Anesthetic
Monograph active ingredient
Phenol
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 phenol product actually contains is on its own Drug Facts panel.
Phenol is an oral anaesthetic used in sore throat sprays and lozenges. 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
The monograph permits phenol, but no lozenge, pastille, troche or gum in the current FDA listing contains it . A permitted ingredient is not the same as an ingredient on a shelf, and this is one that is on the books without being in the box. Not currently listed
This page reports what the FDA monograph permits, not what you should take. It is not medical advice, and it makes no claim that phenol 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.