Every medicine box in a Japanese drugstore has a small boxed label on the front reading 第1類医薬品, 第2類医薬品 or 第3類医薬品. If you cannot read the rest of the packet, this is the part to learn. It tells you who is allowed to sell the medicine to you, and whether anyone in the shop has to explain it.

This came up while we were going through the women's health shelf, so the examples below are from there. The rule itself applies to every non-prescription medicine in the country.

The three classes

Japan sorts non-prescription medicine into three classes by risk. The rules for each are set out in Articles 36-9 and 36-10 of the Pharmaceuticals and Medical Devices Act.

第3類医薬品CLASS 3
Who may sell itA pharmacist or a registered seller Where it sitsOpen shelf. Take it to the till yourself Must they explain itA duty of effort. Ask if you want it
第2類医薬品CLASS 2
Who may sell itA pharmacist or a registered seller Where it sitsOpen shelf. Take it to the till yourself Must they explain itA duty of effort. Ask if you want it
第1類医薬品CLASS 1
Who may sell itA pharmacist only Where it sitsBehind the counter. No pharmacist on duty, no sale Must they explain itRequired by law
低Lower risk 高Higher risk
Classes run from lower risk on the left to higher risk on the right. Among the examples the health ministry gives, 漢方製剤 (herbal preparations) sit in Class 2, while 生理痛用薬 (period pain medicine) and 膣カンジダ用薬 (vaginal thrush treatment) sit in Class 1. Source: Ministry of Health, Labour and Welfare working group paper, May 2013 (in Japanese).

Only the number changes: 1, 2 or 3, sitting between 第 and 類. The rest of the label is identical on every packet.

What a “registered seller” is

A 登録販売者 is a licensed seller of non-prescription medicine who is not a pharmacist. They pass a prefectural exam and can handle Class 2 and Class 3 products. That is how a drugstore keeps selling most of its medicine when no pharmacist is on duty, and why the person helping you may not be a pharmacist at all.

What this means in the aisle

The practical difference lands on Class 1. If a product is Class 1, a pharmacist has to be there and has to give you information. In many shops that means the product sits behind the counter, and if the pharmacist has gone home you cannot buy it that day.

Class 2 and Class 3 are the opposite. You can take the box off the shelf, walk to the till and pay. Nobody is obliged to talk you through it.

Ask, and they will tell you. For Class 2 and Class 3 the duty to explain is only a duty of effort. If you want the ingredients, the dose or the warnings gone over, you usually have to raise it yourself. Nobody staying quiet at the till is the shop being unhelpful. It is just the default.

Where women's health products sit

Take Inochi no Haha A (命の母A), a herbal medicine for menopausal symptoms made by Kobayashi Pharmaceutical (小林製薬), one of the larger Japanese makers of over-the-counter medicine. Its box is marked 第2類医薬品. So it sits on the open shelf, a registered seller can ring it up, and nobody has to explain it unless you ask.

These are not simple products. Inochi no Haha A contains thirteen herbs alongside B vitamins, vitamin E, calcium and taurine, and its leaflet runs to a long list of indications and cautions. None of that reaches you automatically at the till.

The other label on the box

Above the product name on a box like this you may also see 女性保健薬 (josei hokenyaku). This is not a class. It describes what kind of medicine it is. The leaflet for Inochi no Haha A defines it as a medicine intended to relieve symptoms particular to women and to support general health.

One thing the leaflet is explicit about: it is not a hormone preparation. If you came to Japan expecting to find hormone replacement therapy on a shelf, this is not that. It is a herbal preparation, and the leaflet describes it as working gently.

A class number is not a safety rating. Class 2 does not mean mild or harmless. It describes the level of regulatory caution around selling it, nothing more. The leaflet inside the box is still where the warnings, the dose and the list of people who should not take it are written.

If you cannot read the leaflet

The leaflet folded inside the box is in Japanese, and for most products that is the only version there is. A few manufacturers publish an English leaflet as well. Those are not always dependable. Kobayashi's English leaflet for Inochi no Haha A defines 血の道症 as covering mental anxiety and frustration. The Japanese leaflet defines it as covering psychological, neurological and physical symptoms. The English version leaves a whole category out.

As we work through these products, the ingredients, dose and cautions go up in English on our Women's Health page, translated from the Japanese leaflet rather than from the manufacturer's own English version.

Further reading

Our sister site OTC Guide Japan covers the class system and the back of the box in more depth, across all kinds of medicine rather than just women's health:

Sources: the Japanese package leaflet and official product page for 女性保健薬 命の母A (Kobayashi Pharmaceutical); Articles 36-9 and 36-10 of the Pharmaceuticals and Medical Devices Act.