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 41 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Wal-Mart Stores, Inc.	750e0355-369e-b679-e053-2a91aa0a66ca	2023-11-01	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Wal-Mart Stores, Inc.	750efd58-5845-fbc4-e053-2a91aa0a86d1	2023-11-01	Warnings	Exact identifier application number: M007
Gentle Laxative	MAGNESIUM HYDROXIDE	WALGREEN COMPANY	ba4a29b3-2ddc-b906-e053-2995a90a2ab7	2023-11-01	Warnings	Exact identifier application number: M007
DOCUZEN	SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG	Proficient Rx LP	92879e62-f60a-4ab4-9532-610cdd2628ee	2023-11-01	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	A-S Medication Solutions	5999904a-6ac8-4d9e-951c-6e64e8cd93eb	2023-11-01	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	VALU MERCHANDISERS COMPANY	5e98f9d9-679c-63a2-e053-2991aa0a4b8d	2023-10-31	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	VALU MERCHANDISERS COMPANY	5e957b01-4f44-0a2a-e053-2991aa0a37a0	2023-10-31	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	VALU MERCHANDISERS COMPANY	5e993b13-8dc8-6653-e053-2a91aa0a4c2a	2023-10-31	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	CVS	3c8e4144-6702-2678-e054-00144ff88e88	2023-10-31	Warnings	Exact identifier application number: M007
Fiber Laxative	CALCIUM POLYCARBOPHIL	Magno-Humphries, Inc.	9d22c208-d089-8b6a-e053-2995a90ab90a	2023-10-27	Warnings	Exact identifier application number: M007
Stool Softener Docusate Sodium	DOCUSATE SODIUM	Magno-Humphries, Inc.	a0e6ab9b-fd31-45fd-93d5-b51d705c180a	2023-10-27	Warnings	Exact identifier application number: M007
Sennosides Natural Laxative	SENNOSIDES	Magno-Humphries, Inc.	9d22bedb-9fca-8421-e053-2a95a90acf4a	2023-10-27	Warnings	Exact identifier application number: M007
Stool Softener Docusate Sodium	DOCUSATE SODIUM	Magno-Humphries, Inc.	9d22d642-8aed-d17e-e053-2995a90ae182	2023-10-27	Warnings	Exact identifier application number: M007
Senna S	DOCUSATE SODIUM, SENNOSIDES	Magno-Humphries, Inc.	9deaf264-6af0-40ba-e053-2a95a90ada0e	2023-10-27	Warnings	Exact identifier application number: M007
FLEET	MINERAL OIL	C.B. Fleet Company, Inc.	2528cb5e-437e-41f0-9c34-e9ce57404d8b	2023-10-26	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAJOR MAGNESIUM CITRATE ORAL SOLUTION - LEMON	Major Pharmaceuticals	088e5543-c947-af78-e063-6294a90a8bc4	2023-10-25	Warnings	Exact identifier application number: M007
DOK	DOCUSATE SODIUM	MAJOR PHARMACEUTICALS	7a92070d-98cc-662f-e053-2991aa0aa1b2	2023-10-23	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	KROGER COMPANY	a1afaa71-7e8c-5a49-e053-2a95a90a4db0	2023-10-23	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Geri-Care Pharmaceutical Corp	644d81ec-d38f-4172-a087-727b94e2fefe	2023-10-19	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Asclemed USA, Inc.	30fc8c07-c26b-4bcc-a727-6e193f5727fd	2023-10-16	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