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 9 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener plus Stimulant Laxative	DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG	CARDINAL HEALTH, 110 DBA LEADER	3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce	2026-03-06	Warnings	Exact identifier application number: M007
Magnesium Citrate	EQUATE MAGNESIUM CITRATE ORAL SOLUTION - LEMON	Walmart Inc.	484d0421-59ea-3783-e063-6394a90af633	2026-03-04	Warnings	Exact identifier application number: M007
Magnesium Citrate	EQUATE MAGNESIUM CITRATE ORAL SOLUTION - CHERRY	Walmart Inc.	484c2586-9e6f-1ce5-e063-6394a90a0d81	2026-03-04	Warnings	Exact identifier application number: M007
Magnesium Citrate	EQUATE MAGNESIUM CITRATE ORAL SOLUTION - GRAPE	Walmart Inc.	450ddcbd-7ccd-3670-e063-6294a90ac2bd	2026-03-04	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Amazon.com Services LLC	787ec4b0-c6c5-44ab-a53d-d6d25304f95e	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Old East Main Co.	3d0d63d7-640d-4e54-a6fd-6b265c79be09	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Old East Main Co.	9b3b6cea-ab83-4b7c-a425-fd0ac7df426c	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Old East Main Co.	51ed515b-cc51-4ea1-b612-090476135005	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Old East Main Co.	a8af6e2d-0052-4fc9-a51a-c9dbeb1ad3f5	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Chain Drug Marketing Association	629c5817-13b7-4527-8998-93131ee3529e	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Chain Drug Marketing Association	4df97cdc-e7a2-4350-8f95-a679cdcaff64	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Chain Drug Marketing Association	46b26b44-e065-4337-a071-fa036f897140	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Chain Drug Marketing Association	ef163b24-ce92-4cbc-b45a-4fae3b511949	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Chain Drug Marketing Association	4ee26633-8eb1-4c68-a768-20460404533a	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Chain Drug Marketing Association	3bfdad9c-ac58-4e92-b952-555e8a8351cd	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	The Kroger Co.	2bcab227-42b6-4bff-8363-f6800665755b	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	The Kroger Co.	a87dceb2-da73-4d3a-b87c-db2af10471bf	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M007
Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	The Kroger Co.	3ae7e275-7bbc-4e62-b30f-013c40a89949	2026-02-27	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	CVS Pharmacy, Inc	0b7736df-c7de-7d00-e063-6294a90aa57e	2026-02-26	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM	DOCUSATE SODIUM	PD-Rx Pharmaceuticals, Inc.	5d300ea7-78eb-4e19-8333-1e42c73c4c54	2026-02-26	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