Prescription vs OTC in Japan: What You Can (and Can't) Buy at Pharmacies

If you've spent any time in Japan, you may have noticed something odd. A painkiller that requires a prescription in the United States sits openly on the drugstore shelf in Tokyo. An allergy medicine you used to grab at any U.S. supermarket can only be bought from behind the pharmacy counter — and only when a pharmacist is on duty. And the ADHD medication you take daily back home? It may be illegal to bring into Japan at all.

Japan's medicine system looks similar to the U.S. or U.K. on the surface, but the details are different in ways that matter — sometimes a lot.

This guide, written by a Japanese pharmacist for foreign residents and travelers, walks through four things you actually need to know:

1. How Japan classifies medicines (prescription vs OTC, and the four OTC subcategories)
2. Drugs that are prescription-only abroad but OTC in Japan
3. Drugs that are OTC abroad but prescription-only or restricted in Japan
4. The customs rules for bringing your own medication into Japan (the "Yakkan Shoumei" system)

By the end, you should know exactly what to expect when you walk into a Japanese pharmacy.

Before we start: this is general information, not medical advice

Everything below reflects Japanese regulations and product information current as of May 2026. It does not replace personalized advice from a doctor or pharmacist — your symptoms, age, other medications, and medical history all matter. A full disclaimer is at the end of this article.

1. How Japan classifies medicines

Japan splits all medicines into two large groups.

OTC drugs are then divided into four subcategories based on who can legally sell them and how much information they must give you.

→ For more on the difference between drugstores and dispensing pharmacies, see A guide to Japanese pharmacy types.

A common pitfall for foreign customers: the person in the white coat is not always a pharmacist. Many Japanese drugstores are staffed by registered sellers (登録販売者), who can sell Class 2 and 3 OTC products but not Class 1. If you go in at 9 p.m. looking for Loxonin S and only a registered seller is on duty, you cannot buy it that night.

2. Prescription abroad, OTC in Japan

This is the part that surprises American visitors most.

Loxonin S (loxoprofen 60 mg) — Class 1

A prescription-strength NSAID similar to ibuprofen. Loxoprofen remains a prescription drug under U.S. FDA, but Japan switched it to OTC in 2011. You can buy a 12-tablet box at any drugstore that has a pharmacist on duty.

→ More: What is Loxonin S?

Gaster 10 (famotidine 10 mg) — Class 1

The H2 blocker famotidine is sold in the U.S. as Pepcid AC (10 mg) over the counter, and the equivalent dose is OTC in Japan as Gaster 10. Useful for heartburn and acid stomach.

→ More: Stomach medicine in Japan

Allegra FX, Claritin EX, Alesion 20 — Class 2

Second-generation antihistamines (fexofenadine, loratadine, epinastine) are OTC in both the U.S. and Japan, although the Japanese versions are typically lower-dose than U.S. equivalents and require slightly different labeling.

→ More: Hay fever medicine in Japan

Voltaren EX gel/patch (diclofenac sodium 1%) — Class 2 (topical)

Oral diclofenac is prescription-only in the U.S. and U.K., but topical diclofenac gel and patches are OTC in Japan. Note that topical Loxonin S patches and gels are also Class 2 — different from the Class 1 oral tablets.

→ More: Topical pain relief in Japan

3. Prescription-only in Japan (no matter what)

Some medicines that can be obtained over the counter in certain countries — particularly parts of Asia, Eastern Europe, and Latin America — are strictly prescription-only in Japan. In most of the U.S. and Western Europe these are already prescription drugs, but rules vary widely worldwide, so it is worth checking the Japan side carefully.

Antibiotics. Amoxicillin, levofloxacin, azithromycin, and the rest are all prescription-only in Japan — even for a sore throat or a UTI. Some countries allow antibiotics to be sold at a pharmacy without a prescription, but Japan does not, in order to limit antimicrobial resistance. Registered sellers are not permitted to dispense them.

Sleep and anti-anxiety medications. Benzodiazepines such as lorazepam (Ativan), alprazolam (Xanax), and diazepam (Valium), as well as Z-drugs like zolpidem (Ambien) — all prescription-only. The OTC product Drewell (ジフェンヒドラミン / diphenhydramine) is a sedating antihistamine marketed only as a sleep aid; it is not a substitute for a benzodiazepine.

ADHD medications. All ADHD medicines are prescription-only in Japan. Concerta (methylphenidate) and Vyvanse (lisdexamfetamine) are tracked through the ADHD Proper Distribution Management System — only registered doctors, pharmacies, and patients can be involved in their dispensing, because both fall under the stimulants/raw-material control framework. Strattera (atomoxetine), on the other hand, is not part of that system and is not a controlled substance — it is prescribed as an ordinary prescription drug at psychiatry, psychosomatic medicine, or paediatric clinics. In all cases, you must see a Japanese doctor in person; foreign prescriptions cannot be transferred.

Oral contraceptives. Discussions about OTC oral contraceptives are ongoing in Japan, but as of May 2026, all combined and progestin-only pills remain prescription-only and are dispensed at gynaecology clinics or some online clinics. (Pharmacy-based emergency contraception is being trialed — see below.)

Emergency contraception. Levonorgestrel-based emergency contraceptives have been part of a pilot program since December 2023, sold at a limited list of designated pharmacies after a face-to-face consultation with a specially trained pharmacist. They are not yet available nationwide on demand.

Erectile dysfunction drugs. Sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra) are prescription-only. Many fake products circulate online — always go through a clinic.

4. OTC abroad, restricted in Japan

The reverse case: medications you may have used freely overseas, but which are harder to find — or simply unavailable — in Japan.

Advil PM (ibuprofen + diphenhydramine)

A common U.S. nighttime painkiller. Japan does not have an equivalent fixed-dose combination as a mainstream OTC.

The closest match by ingredient is to combine Eve A (ibuprofen) with Drewell (diphenhydramine sleep aid) — purchased separately. Be aware, however, that combining diphenhydramine-containing products can amplify drowsiness and anticholinergic effects (dizziness, dry mouth, urinary retention), so always confirm with a pharmacist before taking them together.

High-dose Benadryl (oral diphenhydramine for allergies)

In the U.S., Benadryl is the go-to OTC antihistamine for allergic reactions. In Japan, the mainstream use of oral diphenhydramine OTC is as a sleep aid (Drewell). An allergy-indicated diphenhydramine OTC does exist — Restamin Kowa Tablets (Class 2, indicated for hives, eczema, and itching) — but because it is sedating, it is rarely the first choice for everyday allergy management.

For hay fever or hives, the standard approach in Japan is to start with a second-generation antihistamine — Allegra FX, Claritin EX, or Alesion 20 — and consider Restamin Kowa only when symptoms warrant it or when a pharmacist recommends it. Don't expect U.S. Benadryl to map onto a single high-dose Japanese OTC.

Codeine-containing cough medicines

U.S. cough syrups containing codeine (Robitussin AC, Cheratussin AC) are themselves prescription or controlled in many states. In Japan, codeine-containing OTC cough medicines have been prohibited for children under 12 since 2019.

A small number of codeine-containing OTC cough products remain on the market for adults, but abuse-prevention controls — sales record-keeping, per-purchase quantity limits, and pharmacist-mediated sales — have been progressively tightened. Do not assume Robitussin AC has a direct equivalent on Japanese drugstore shelves.

→ More: Children's OTC medicine in Japan

5. Bringing your own medication into Japan: the customs rules

This is where most travelers get into trouble. Bringing in more than the permitted amount can lead to confiscation at the airport — and in some cases criminal proceedings.

5-1. Personal-use limits without paperwork

For your own personal use, you may bring the following amounts into Japan without applying for a Yakkan Shoumei (medication import certificate, also known as Yakkan Shōmei).

Above these amounts — or for injectables and narcotics — you must apply for a Yakkan Shoumei in advance.

5-2. Psychotropics: rules vary by class and quantity

Psychotropics (benzodiazepines, Z-drugs, certain codeine-containing painkillers, etc.) are categorised in Japan as Class 1, Class 2, or Class 3 psychotropics, and the personal-use quantity allowed without paperwork differs for each class and substance. Some can be brought in within the limit without a Yakkan Shoumei; others cannot.

Because the matrix is detailed, the safe practical approach is: if you take any psychotropic regularly, apply for a Yakkan Shoumei in advance. The application is free, handled by email through the Regional Bureau of Health and Welfare, and typically issued within a few business days to two weeks. You will need a copy of your prescription and a doctor's letter explaining the medical need.

If you are over the personal-use limit and have not obtained a Yakkan Shoumei, expect serious problems at the airport. Before flying, always confirm your specific medication against the most current MHLW guidance.

5-3. Drugs that are illegal to bring into Japan

Some medications are prohibited entirely under Japanese law, even with a valid foreign prescription. Carrying them into Japan may result in confiscation and criminal proceedings. The most important examples for U.S. travelers:

If you take Adderall for ADHD, plan ahead before you fly. Vyvanse (lisdexamfetamine) is approved in Japan as a domestic product (sold as Vyvanse Capsules), but you cannot import it yourself. Once in Japan, see a psychiatrist registered in the ADHD Proper Distribution Management System and discuss switching to Concerta, Strattera, or domestic Vyvanse.

5-4. CBD and THC

Japan revised its Cannabis Control Act in December 2024. CBD products circulating in Japan must contain THC at or below the residual threshold set by the Ministry of Health, Labour and Welfare — the law no longer requires "zero THC" but does require staying within that limit. Imported CBD gummies, oils, and vape products from overseas frequently cannot be objectively verified against this threshold, and Japanese customs has been confiscating them — and in some cases prosecuting travelers — under the Cannabis Control Act. Avoid bringing foreign CBD products.

6. Useful Japanese phrases for the pharmacy

When buying Class 1 products such as Loxonin S or Gaster 10, ask specifically for a pharmacist (yakuzaishi) — registered sellers cannot legally sell them.

7. If you actually need a prescription

Once it becomes clear that the OTC route won't work, the next step is seeing a doctor. Two practical guides:

• How to see a doctor in Japan — paperwork, insurance, and what to expect at a Japanese clinic
• Feeling sick at night in Japan? Dial #7119 — for urgent but not emergency situations

Summary: a three-step rule of thumb

1. Assess severity first. High fever lasting more than three days, severe abdominal pain, breathing difficulty — go to a clinic, not a drugstore.
2. For OTC-treatable issues, check the class. Class 1 medicines need a pharmacist on duty.
3. Before bringing medication from home, check Japanese customs rules. Stimulant ADHD medications such as Adderall cannot be brought in at all; for benzodiazepines and similar psychotropics, the rules vary by class and quantity, so when in doubt apply for a Yakkan Shoumei.

If in doubt, talk to a pharmacist. Japanese pharmacists are increasingly used to working with foreign customers — don't hesitate to ask.

Sources

• Pharmaceuticals and Medical Devices Agency (PMDA) — Package insert database
• Ministry of Health, Labour and Welfare (MHLW) — "Importing medicines for personal use"
• MHLW — "Risk classification of OTC medicines"
• Regional Bureau of Health and Welfare — Yakkan Shoumei application guidance
• U.S. Embassy Tokyo — "Importing medication into Japan" (2025 edition)
• U.S. FDA — Drugs@FDA database
• ADHD Proper Distribution Management System (Japan)
• Product package inserts for Loxonin S, Gaster 10, Allegra FX, Drewell, and others

About the author

Sakura is a licensed Japanese pharmacist and medical writer who specializes in OTC medicines and the medical-information needs of foreign readers in Japan. James translated and adapted this article for English-speaking readers; he holds a PhD in Pharmacy from Waseda University and has worked on PMDA English-language regulatory translation for over a decade.

Disclaimer

This article is for informational purposes only and does not constitute medical advice. The medication classifications, sales conditions, and customs rules described above reflect Japanese regulations as of May 2026 and may change. Before purchasing, taking, or importing any medication, please consult a licensed pharmacist or physician, and verify the latest information from official sources such as the PMDA, the Ministry of Health, Labour and Welfare, Japan Customs, and the relevant Regional Bureau of Health and Welfare. The publisher assumes no responsibility for actions taken on the basis of this article.