Mineral oil

Product NDC: 63868-938
11-digit product format: 638680938
Labeler code: 63868
Product ID: 63868-938_ca3086e8-2446-49e4-9816-997ef2e4f9fe
Type: HUMAN OTC DRUG
Nonproprietary name: Mineral oil
Dosage form: OIL
Route: ORAL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-07-31
Marketing end: 2025-05-30
Substance: MINERAL OIL
Active strength: 100 mg/100mL
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63868-938		D	Discontinued by firm		2026-10-05
excluded package	package	63868-938	63868-938-16	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63868-938-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63868-938-16	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-938-16	ML - Milliliter	63868-938	96508fd8-4f9e-4ebf-88f4-799b03e181c6	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	MINERAL OIL OIL [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	2
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	MINERAL OIL OIL [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	2
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	MINERAL OIL OIL [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-938	MINERAL OIL OIL [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	5	Legacy NDC	20221105_b53b68de-e2b6-4c8b-b486-2e8aba32a9b6.zip

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
63868-938-16	63868093816	473 mL in 1 BOTTLE (63868-938-16)	473 ml	2014-07-31	2025-05-30	No	No	Current