Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drugs

The Food and Drug Administration (FDA) has established a set of regulations called the "OTC monograph" for over-the-counter (OTC) cold, cough, allergy, bronchodilator, and antiasthmatic drugs. This monograph outlines the conditions under which these medications are considered safe and effective for self-treatment. It ensures ingredients, dosage amounts, and labeling meet specific criteria. The goal is to make sure these common medications are helpful for mild symptoms while preventing misuse or misleading claims.

M012.12 Antihistamine active ingredients

Active Ingredients OTC Monograph Number
Brompheniramine maleateM012.12 (Part 341)
Chlorcyclizine hydrochlorideM012.12 (Part 341)
Chlorpheniramine maleateM012.12 (Part 341)
Dexbrompheniramine maleateM012.12 (Part 341)
Dexchlorpheniramine maleateM012.12 (Part 341)
Diphenhydramine citrateM012.12 (Part 341)
Diphenhydramine hydrochlorideM012.12 (Part 341)
Doxylamine succinateM012.12 (Part 341)
Phenindamine tartrateM012.12 (Part 341)
Pheniramine maleateM012.12 (Part 341)
Pyrilamine maleateM012.12 (Part 341)
Thonzylamine hydrochlorideM012.12 (Part 341)
Triprolidine hydrochlorideM012.12 (Part 341)

M012.14 Antitussive active ingredients

Active Ingredients OTC Monograph Number
Oral antitussives
  • Chlophedianol hydrochloride
  • Codeine
  • Codeine phosphate
  • Codeine sulfate
  • Dextromethorphan
  • Dextromethorphan hydrobromide
  • Diphenhydramine citrate
  • Diphenhydramine hydrochloride
M012.14 (Part 341)
Topical antitussives
  • Camphor
  • Menthol
M012.14 (Part 341

M012.16 Bronchodilator active ingredients

Active Ingredients OTC Monograph Number
EphedrineM012.16 (Part 341)
Ephedrine hydrochlorideM012.16 (Part 341)
Ephedrine sulfateM012.16 (Part 341)
EpinephrineM012.16 (Part 341)
Epinephrine bitartrateM012.16 (Part 341)
Racephedrine hydrochlorideM012.16 (Part 341)
Racepinephrine hydrochlorideM012.16 (Part 341)

M012.18 Expectorant active ingredients

Active Ingredients OTC Monograph Number
GuaifenesinM012.18 (Part 341)

M012.20 Nasal decongestant active ingredients

Active Ingredients OTC Monograph Number
Oral nasal decongestants
  • Phenylephrine hydrochloride
  • Pseudoephedrine hydrochloride
  • Pseudoephedrine sulfate
  • Phenylephrine bitartrate in an effervescent dosage form
M012.20 (Part 341)
Topical nasal decongestants
  • Levmetamfetamine
  • Ephedrine
  • Ephedrine hydrochloride
  • Ephedrine sulfate
  • Naphazoline hydrochloride
  • Oxymetazoline hydrochloride
  • Phenylephrine hydrochloride
  • Propylhexedrine
  • Xylometazoline hydrochloride
M012.20 (Part 341)