FDA Registration for OTC Laxative Drug Products

OTC laxative products containing bisacodyl, senna, or psyllium are regulated as OTC Monograph drugs by FDA — requiring establishment registration and drug listing.

OTC MonographDrug Facts Required21 CFR Part 207Since 2009

FDA Requirements for OTC Laxative Drug Products

OTC laxative drug products are regulated under FDA’s OTC Monograph system. There are multiple categories: stimulant laxatives (castor oil, dehydrocholic acid), bulk-forming laxatives (psyllium, methylcellulose), hyperosmotic laxatives (glycerin, sorbitol), and lubricant laxatives (mineral oil).

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

Over-the-counter (OTC) laxative monographs are guidelines established by the U.S. Food and Drug Administration (FDA) to ensure the safety and effectiveness of laxatives available without a prescription. These monographs outline different types of laxatives, such as bulk-forming, stimulant, stool softener, and saline laxatives. They specify ingredients, dosage amounts, and labeling requirements to help consumers choose the right laxative for occasional constipation. The FDA also reviews and updates these monographs to reflect new scientific information and ensure consumer safety.

M007.10 Bulk-forming laxative active ingredients

Active Ingredients	OTC Monograph Number
Bran	M007.10 (Part 334)
Cellulose (semisynthetic) ingredients Methylcellulose Sodium carboxymethylcellulose	M007.10 (Part 334)
Karaya	M007.10 (Part 334)
Malt soup extract	M007.10 (Part 334)
Polycarbophil	M007.10 (Part 334)
Psyllium ingredients except those (in granular dosage form) listed in Non-Monograph Conditions NM900. Plantago ovata husks Plantago seed Psyllium (hemicellulose) Psyllium hydrophilic mucilloid Psyllium seed Psyllium seed (blond) Psyllium seed husks	M007.10 (Part 334)

M007.12 Hyperosmotic laxative active ingredients

Active Ingredients	OTC Monograph Number
Glycerin	M007.12 (Part 334)
Sorbitol	M007.12 (Part 334)

M007.14 Lubricant laxative active ingredients

Active Ingredients	OTC Monograph Number
Mineral oil when used within the dosage limit established	M007.14 (Part 334)

M007.16 Saline laxative active ingredients

Active Ingredients	OTC Monograph Number
Magnesium citrate	M007.16 (Part 334)
Magnesium hydroxide	M007.16 (Part 334)
Magnesium sulfate	M007.16 (Part 334)
Dibasic sodium phosphate/monobasic sodium phosphate marketed as a solution	M007.16 (Part 334)
Dibasic sodium phosphate	M007.16 (Part 334)
Monobasic sodium phosphate	M007.16 (Part 334)

M007.18 Stimulant laxative active ingredients

Active Ingredients	OTC Monograph Number
Castor oil	M007.18 (Part 334)
Dehydrocholic acid	M007.18 (Part 334)

M007.20 Stool softener laxative active ingredients

Active Ingredients	OTC Monograph Number
Docusate calcium	M007.20 (Part 334)
Docusate potassium	M007.20 (Part 334)
Docusate sodium	M007.20 (Part 334)

M007.22 Carbon-dioxide-releasing laxatives

Active Ingredients	OTC Monograph Number
Carbon dioxide released from combined sodium biphosphate anhydrous, sodium acid pyrophosphate, and sodium bicarbonate	M007.22 (Part 334)
Carbon dioxide released from combined sodium bicarbonate and potassium bitartrate	M007.22 (Part 334)

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.

OTC Laxative Drug Products — FAQs

Common questions about FDA registration requirements for otc laxative drug products.

Are OTC laxatives regulated as drugs?

Yes. All OTC laxative products making constipation relief claims are regulated as OTC drugs.

What laxative categories exist under FDA OTC Monograph?

Stimulant (castor oil, dehydrocholic acid), bulk-forming (psyllium), Hyperosmotic (glycerin, sorbitol), saline (magnesium hydroxide), and lubricant (mineral oil) laxatives are recognized categories.