Anesthetic
Monograph active ingredient
Dyclonine hydrochloride
Oral anesthetic/analgesic under FDA monograph M022. That monograph is not in the Code of Federal Regulations, so no permitted strength is quoted here.
What the monograph permits
What a given dyclonine hydrochloride product actually contains is on its own Drug Facts panel. The strengths across the 3 FDA-listed products that contain it are on the Dyclonine hydrochloride product page.
A local anaesthetic used in throat lozenges, chemically unrelated to the caine anaesthetics. The oral health care monograph (M022) is not codified in the Code of Federal Regulations. It was proposed as 21 CFR part 356 in 1988 and again in 1994 and never finalised, so there is no regulatory text to quote a strength from. This page states the monograph category, which is FDA's own Drug Facts Purpose vocabulary, and does not assert a permitted strength range, because none is codified. What a given product actually contains is on its label.
On the shelf
3 FDA-listed products in a lozenge, pastille, troche or gum contain dyclonine hydrochloride. What they weigh, who makes them and how they are marketed is on the Dyclonine hydrochloride product page, which is built from the FDA National Drug Code Directory rather than from the monograph.
This page reports what the FDA monograph permits, not what you should take. It is not medical advice, and it makes no claim that dyclonine hydrochloride is effective for any condition. Always follow the product label, and ask a pharmacist or a doctor.
Lozenges.com is a reference publication built from FDA product listings and drug labels. It is not medical advice, diagnosis or treatment, it does not recommend any product for any condition, and it is not a substitute for a pharmacist or a doctor.