Mineral Oil

Product NDC: 46122-395
11-digit product format: 461220395
Labeler code: 46122
Product ID: 46122-395_3fff7ff5-b86e-4d83-a612-623e245ecd97
Type: HUMAN OTC DRUG
Nonproprietary name: Mineral Oil
Dosage form: OIL
Route: ORAL; TOPICAL
Labeler: AmerisourceBergen (Good Neighbor Pharmacy) 46122
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-11-30
Substance: MINERAL OIL
Active strength: 100 mg/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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
Listing expiration: 2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
T5L8T28FGP	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
581f81a0-7488-4c90-b33e-06c6301a4fd2	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46122-395-16	Mineral Oil	473 mL in 1 BOTTLE, PLASTIC	OIL	473		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46122-395-16	ML - Milliliter	46122-395	289f1dd6-2d78-420a-ba77-1e442dd824ff	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46122-395	MINERAL OIL OIL [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]	8	Current NDC, Legacy NDC, 1 package rows	20250418_581f81a0-7488-4c90-b33e-06c6301a4fd2.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 42 of 42 · 826 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Senna Lax	SENNOSIDES 8.6MG	Allegiant Health	94a9c24a-07c3-4535-b810-b7abc9fc5ad5	2019-12-11	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Marc Glassman, Inc.	ec34fc1e-d122-4fa4-859e-e89e3e12edd5	2019-09-18	Warnings	Exact identifier application number: M007
Womens Laxative	BISACODYL	Marc Glassman, Inc.	aeb3c49b-cbf5-4a47-b19c-e77fbb987a49	2019-09-17	Warnings	Exact identifier application number: M007
Bisacodyl 5mg	BISACODYL 5MG	Allegiant Health	46a377f5-822b-496f-a73b-66d8f902680a	2019-03-26	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Allegiant Health	51f1c6c0-770c-4426-820b-bc1f42e143fd	2019-02-07	Warnings	Exact identifier application number: M007
Senna-Lax	SENNOSIDES	Marc Glassman, Inc.	7dd97c54-2ba1-4629-87b9-1ba0913fe531	2016-12-27	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
46122-395-16	46122039516	473 mL in 1 BOTTLE, PLASTIC (46122-395-16)	473 ml	2016-11-30	0000-00-00	No	No	Current