Skip to content
AlternativeMed

Reading a Chinese Patent Medicine Label

How to read what is, and is not, on a Chinese patent medicine label: registration numbers by country, ingredient names, and why a label alone cannot prove what is inside.

Content last updated . This page has not been medically reviewed.

What this page covers

A Chinese patent medicine (also called a proprietary Chinese medicine) is a ready-made product, usually a pill, tablet, capsule, granule or liquid, made from a set formula. This page explains what a label can tell you, what it cannot, and what to check before using one. It is information only. It does not tell you what to take. For the wider picture see Chinese herbal medicine: what it is and what research shows.

Start with the most important limit

A label is a claim by the seller, not a test result. An overview of 26 systematic reviews found herbal products adulterated or contaminated with materials ranging from pesticides and heavy metals to prescription drugs, with serious harm in some cases; contamination was most often noted for Chinese remedies. [1] The US National Center for Complementary and Integrative Health (NCCIH) says some Chinese herbal products have been found contaminated with undeclared plant or animal material, drugs such as warfarin and diclofenac, heavy metals, and pesticides. [2]

In one laboratory study, DNA sequencing of 15 traditional Chinese medicine samples found plants such as Ephedra and Asarum, and animal families that include endangered species, and said animal DNA was rarely declared on the packaging. [3] That is a small sample, but it shows why "not listed" does not always mean "not present".

What a registration number means in different places

Rules differ by country, and a number on a label means something different in each.
PlaceWhat to look forWhat it means, according to the regulator or health authority
Hong KongA registration number in the form HKC followed by five digitsRegistered products are required to carry it on the package. Selling or possessing an unregistered proprietary Chinese medicine is an offence, and the Chinese Medicine Council lists registered products. [4]
CanadaAn eight-digit Natural Product Number (NPN) or homeopathic numberHealth Canada says it indicates a licensed product. Having no number does not necessarily mean unsafe, only that the product has not been assessed. [5]
EnglandA Traditional Herbal Registration (THR) mark and product code from the MHRAThe NHS says these show the medicine is licensed in England and meets safety standards. [6]
United StatesNo premarket approval numberFDA does not approve dietary supplements before they are sold; firms are responsible for the safety and labeling of their products. [7][8]
Mainland ChinaA drug approval numberChina's drug regulator (NMPA) has rules on registration classes, drug names and package inserts for traditional Chinese medicines. [9] We did not read a source describing the number format, so we do not describe it here.

Australia: we could not read the Therapeutic Goods Administration's pages in this session, so we make no statement about its listing numbers. Check the TGA directly.

Reading the rest of the label

Hong Kong's Chinese Medicine Regulatory Office lists what a registered product's label must show: the name of the medicine, active ingredients, country of origin, registration number, registration holder, dosage and method of use, expiry date and batch number. [4] Those are a good checklist anywhere. Look for:
  • A full ingredient list in a language you can read. Chinese herbs are often named in pinyin (Chinese romanization), Latin pharmaceutical names, or common English names. The same common name can refer to different plants.
  • Which part of the plant and what species. Names that sound alike can hide very different plants. FDA says outbreaks of kidney failure tied to aristolochic acid arose when the plant on the label was misidentified, or when "traditional Chinese names were misinterpreted or similar". [10]
  • A manufacturer and batch number. These let a company, regulator or poison centre trace a product.
  • Minerals and animal parts. Hong Kong's list of toxic Chinese medicines that need a practitioner's prescription includes cinnabar, realgar, mercury and arsenic compounds. [11] A review of Chinese patent medicines noted cinnabar and calomel as mercury-containing ingredients. [12] We do not recommend products with these ingredients or with endangered-species ingredients (see herb sourcing and sustainability).
  • Claims that sound like a drug. Promises to cure disease are a warning sign, not reassurance.

When the label is not enough

FDA has recalled a Chinese patent medicine sold as a dietary supplement ("Xanthium & Siler Combo (Bi Yan Pian)") because it contained undeclared Ephedra herba (ma huang), which FDA lists as banned. FDA says such supplements carry a risk of serious adverse events, including heart attack, stroke and death. [13] See adulteration and substitution in Chinese herbal products for more examples, and undeclared drugs in Chinese patent medicines. To buy with more care, read buying Chinese herbs safely.

If you feel unwell

Stop the product and seek medical care. In the US, Poison Help is 1-800-222-1222; other countries are on Poison Help by country. Bring the package. In an emergency in the US, call 911.

Frequently asked questions

Does a registration number prove a Chinese patent medicine is safe?

No. It shows the product went through that country's system, which differs by place. Hong Kong requires registration and Canada licenses products, but neither removes the need to check with a clinician or pharmacist. [4][5]

What if my product has no number at all?

Health Canada says no number does not necessarily mean unsafe, only that it has not been assessed. In the US there is no premarket approval for supplements, so absence of a number is normal. [5][7]

Can a label hide ingredients?

Yes. FDA warns of products with hidden ingredients not listed on the label, often prescription drug ingredients or banned substances. [7]

Are ingredients in pinyin enough to identify a plant?

Not reliably. FDA found that confusion between similar Chinese names contributed to aristolochic acid exposure. Ask a pharmacist or qualified practitioner to identify the exact species. [10]

Should I ask a Chinese medicine practitioner before using a patent medicine?

Hong Kong's regulator advises seeking a registered practitioner's advice before buying, and notes that curative products are generally not for long-term use. Practitioner rules vary by place: see TCM qualifications and licensing. [4]

More details: evidence, limits and cautions

The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.

Medicines, pregnancy and children
The NHS advises that herbal medicines are not recommended for children, and that you should not take them if pregnant or breastfeeding, if you have kidney or liver problems, or if you take certain medicines, naming statins, antidepressants, diabetes and blood pressure medicines, warfarin and the combined pill. [6] Always show the box and package insert to a pharmacist or doctor. Do not stop a prescribed medicine on your own. More in Chinese herbal products: quality, contamination and medicine interactions.
References
Education, not medical advice. This page is for general information. It does not diagnose or treat any condition and is not a substitute for care from a qualified health professional. Natural does not automatically mean safe. Ask a clinician or pharmacist before changing your care, especially if you take medication, are pregnant or breastfeeding, or have a health condition.