FDA Registration for OTC Overindulgence Products

Antacid Products for Over-the-Counter Human Use — upset stomach, heartburn, and nausea relief after overeating — are regulated as OTC Monograph drugs by FDA.

OTC MonographDrug Facts Required21 CFR Part 207Since 2009

FDA Requirements for OTC Overindulgence Products

OTC antacid drug products are regulated by FDA. Active ingredients include bismuth aluminate for symptoms associated with overindulgence in food and drink.

FDA Drug Establishment Registration
NDC Labeler Code
Drug Listing with Drug Facts labeling
Annual renewal October 1–December 31

Overindulgence isn’t a medical condition: It’s a temporary state caused by consuming too much food or drink. Symptoms and Indications are addressed in different monographs as per the after-effects. For example, if “heartburn,” “sour stomach,” and/or “acid indigestion” are the symptoms, any antacid can be used as per M001. If minor aches and pain are associated with a hangover, a combination of internal analgesics and stimulants can be used, as stated in M013.20.

Active Ingredients	OTC Monograph Number
(1) Basic aluminum carbonate gel	M001.11 (Part 331)
(2) Aluminum hydroxide	M001.11 (Part 331)
(3) Dihydroxyaluminum aminoacetate and dihydroxyaluminum aminoacetic acid	M001.11 (Part 331)
(4) Aluminum phosphate gel when used as part of an antacid combination product and contributing at least 25 percent of the total acid-neutralizing capacity; maximum daily dosage limit is 8 grams.	M001.11 (Part 331)
(5) Dihydroxyaluminum sodium carbonate	M001.11 (Part 331)
(6) Bicarbonate-containing active ingredients: Bicarbonate ion	M001.11 (Part 331)
(7) Bismuth aluminate	M001.11 (Part 331)
(8) Bismuth carbonate	M001.11 (Part 331)
(9) Bismuth subcarbonate	M001.11 (Part 331)
(10) Bismuth subgallate	M001.11 (Part 331)
(11) Bismuth subnitrate	M001.11 (Part 331)
(12) Calcium-containing active ingredients (Calcium, as carbonate or phosphate; maximum daily dosage limit 160 mEq calcium)	M001.11 (Part 331)
(13) Citrate-containing active ingredients (Citrate ion, as citric acid or salt; maximum daily dosage limit 8 grams.)	M001.11 (Part 331)
(14) Glycine (aminoacetic acid)	M001.11 (Part 331)
(15) Hydrate magnesium aluminate activated sulfate	M001.11 (Part 331)
(16) Magaldrate	M001.11 (Part 331)
(17) Magnesium aluminosilicates	M001.11 (Part 331)
(18) Magnesium carbonate	M001.11 (Part 331)
(19) Magnesium glycinate	M001.11 (Part 331)
(20) Magnesium hydroxide	M001.11 (Part 331)
(21) Magnesium oxide	M001.11 (Part 331)
(22) Magnesium trisilicate	M001.11 (Part 331)
(23) Milk solids, dried	M001.11 (Part 331)
(24) Aluminum phosphate	M001.11 (Part 331)
(25) Mono- or dibasic calcium salt	M001.11 (Part 331)
(26) Tricalcium phosphate	M001.11 (Part 331)
(27) Potassium bicarbonate (or carbonate when used as a component of an effervescent preparation)	M001.11 (Part 331)
(28) Sodium potassium tartrate	M001.11 (Part 331)
(29) Sodium bicarbonate (or carbonate when used as a component of an effervescent preparation)	M001.11 (Part 331)
(30) Magnesium aluminosilicates	M001.11 (Part 331)
(31) Magnesium trisilicate	M001.11 (Part 331)
(32) Tartrate-containing active ingredients (Tartaric acid or its salts; maximum daily dosage limit 200 mEq (15 grams) of tartrate.)	M001.11 (Part 331)

These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.