Mineral Oil

Product NDC: 36800-334
11-digit product format: 368000334
Labeler code: 36800
Product ID: 36800-334_b3d9996c-e3e5-432a-a4bb-32c7fb2aeaad
Type: HUMAN OTC DRUG
Nonproprietary name: Mineral Oil
Dosage form: OIL
Route: ORAL; TOPICAL
Labeler: TOP CARE (Topco Associates LLC)
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-11-30
Marketing end: 2027-12-28
Substance: MINERAL OIL
Active strength: 100 mg/100mL
NDC exclude flag: No
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Mineral Oil

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINERAL OIL	100 mg/100mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-334-16	Mineral Oil	473 mL in 1 BOTTLE, PLASTIC	OIL	473		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-334	MINERAL OIL OIL [TOP CARE (TOPCO ASSOCIATES LLC)]	8	Current NDC, Legacy NDC, 1 package rows	20250426_0dd5380e-9671-4a2b-a2ce-6477503d06d2.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 22 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Senna Syrup	NATURAL VEGETABLE LAXATIVE	Method Pharmaceuticals	ce83ba78-7e0d-b37f-e053-2995a90a9383	2025-10-21	Warnings	Exact identifier application number: M007
Fiber Lax	CALCIUM POLYCARBOPHIL	PD-Rx Pharmaceuticals, Inc.	730198a5-b6d9-4fc7-b053-a7c65a93c540	2025-10-20	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Chain Drug Consortium LLC	4694f05b-d927-4e15-9630-a0a1cddb3cbb	2025-10-16	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Amerisource Bergen/Good Neighbor Pharmacy	e6a8914f-cfd9-4c72-abaa-22189bf0faef	2025-10-16	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Chain Drug Marketing Association Inc.	3386fada-6b7f-46fd-e063-6294a90abffc	2025-10-16	Warnings	Exact identifier application number: M007
Senna Syrup	SENNA SYRUP	Kesin Pharma Corporation	360fb98d-c6ad-7bcc-e063-6294a90a9453	2025-10-14	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	H E B	3d0566a1-57a5-6a31-e054-00144ff88e88	2025-10-09	Warnings	Exact identifier application number: M007
SENNA WITH DOCUSATE SODIUM	DOCUSATE SODIUM AND SENNOSIDES	HHH Pharmaceuticals	2bbb1b99-d43c-40a3-bc53-e18e8394c318	2025-10-08	Warnings	Exact identifier application number: M007
Castor Oil	CASTOR OIL	BIONPHARMA INC.	3f9728e8-c7a2-6cfb-e063-6394a90a8f1d	2025-10-06	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	InvaTech Pharma Solutions LLC	3de39fbd-29be-fce7-e063-6394a90a67ae	2025-10-03	Warnings	Exact identifier application number: M007
Metamucil Therapy for regularity	PSYLLIUM HUSK	The Procter & Gamble Manufacturing Company	a9824f73-5ea2-4a65-a926-3a57561441b8	2025-10-01	Warnings	Exact identifier application number: M007
OneLAX SENNA	SENNA	Atlantic Biologicals Corp.	40202c76-4273-88fd-e063-6394a90a07b2	2025-10-01	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE ORAL SOLUTION	Bionpharma, Inc.	4019fbd0-fcf9-77a6-e063-6294a90a5ae7	2025-09-30	Warnings	Exact identifier application number: M007
LEADER HYDROCORTISONE WITH ALOE	HYDROCORTISONE	LEADER	39916470-15bf-4bd0-96e2-b909d68cf9c4	2025-09-29	Warnings	Exact identifier application number: M007
Leader Ready to Use Mineral Oil Laxative	MINERAL OIL	Cardinal Health	b8494d02-8a7d-47b4-80b0-b8ab51b625fd	2025-09-29	Warnings	Exact identifier application number: M007
Leader Ready to Use Saline Laxative	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Cardinal Health	1b4f9c28-0547-4922-aa15-990c6fd9dc9f	2025-09-29	Warnings	Exact identifier application number: M007
Milk of Magnesia	MAGNESIUM HYDROXIDE	Kesin Pharma Corporation	3f7cff50-749b-5275-e063-6394a90af407	2025-09-23	Warnings	Exact identifier application number: M007
Stimulant Laxative Plus Stool Softener	DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG	Bryant Ranch Prepack	12f613e4-c919-4cc4-a445-eb30039ae45f	2025-09-18	Warnings	Exact identifier application number: M007
Saline Laxative	SALINE LAXATIVE	Major Pharmaceuticals	b3758ffe-1bac-4df6-9714-5e33e9d28d90	2025-09-16	Warnings	Exact identifier application number: M007
Gentle Laxative	BISACODYL	BETTER LIVING BRANDS LLC.	f29d57f6-0938-d459-e053-2995a90ad86b	2025-09-13	Warnings	Exact identifier application number: M007

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T5L8T28FGP	MINERAL OIL	8042-47-5	MINERAL OIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-334-16	36800033416	473 mL in 1 BOTTLE, PLASTIC (36800-334-16)	473 ml	2016-11-30	2027-12-28	No	No	Current