Mineral Oil

Product NDC: 55319-634
Requested package NDC: 55319-634-16
11-digit product format: 553190634
Labeler code: 55319
Product ID: 55319-634_65ef7143-a71d-400a-ae9c-6d293d22a90b
Type: HUMAN OTC DRUG
Nonproprietary name: Mineral Oil
Dosage form: OIL
Route: ORAL; TOPICAL
Labeler: Family Dollar (FAMILY WELLNESS)
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2017-06-30
Marketing end: 2025-06-30
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55319-634	55319-634-16	D	Discontinued by firm		2026-10-20

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 · 5 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55319-634-16	2022-10-31	C162847	48780-1	d6a99b39-6b91-a426-e053-dadaa90af4c2	Drug Facts
55319-634-16	2022-01-28	C162847	48780-1	d6a99b39-6b91-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-634	MINERAL OIL OIL [FAMILY DOLLAR (FAMILY WELLNESS)]	4	Legacy NDC	20221101_14f40d7a-fff8-4488-93e6-9a835f1efd91.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
55319-634-16	55319063416	473 mL in 1 BOTTLE, PLASTIC (55319-634-16)	473 ml	2017-06-30	2025-06-30	No	No	Current