Anesthetic
Monograph active ingredient
Benzocaine
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 benzocaine product actually contains is on its own Drug Facts panel. The strengths across the 36 FDA-listed products that contain it are on the Benzocaine product page.
Benzocaine is a local anaesthetic: in a lozenge it numbs the surface of the throat rather than treating what is causing the pain. 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. Many benzocaine labels carry a warning about methemoglobinemia; that warning is on the package.
On the shelf
36 FDA-listed products in a lozenge, pastille, troche or gum contain benzocaine. What they weigh, who makes them and how they are marketed is on the Benzocaine 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 benzocaine 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.