A and D

Product NDC: 0404-0375
Requested package NDC: 0404-0375-47
11-digit product format: 004040375
Labeler code: 0404
Product ID: 0404-0375_f1628c66-5650-fa92-e053-2995a90a601f
Type: HUMAN OTC DRUG
Nonproprietary name: Petrolatum
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Henry Schein, Inc.
Application: M016
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-12-04
Marketing end: 2024-09-01
Substance: PETROLATUM
Active strength: 938 mg/g
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	0404-0375	0404-0375-47	D	Discontinued by firm		2026-10-23

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	A AND D (PETROLATUM) OINTMENT [HENRY SCHEIN, INC.]	6
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	A AND D (PETROLATUM) OINTMENT [HENRY SCHEIN, INC.]	6
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	A AND D (PETROLATUM) OINTMENT [HENRY SCHEIN, INC.]	6
ERGOCALCIFEROL	INACTIVE INGREDIENT	VS041H42XC	A AND D (PETROLATUM) OINTMENT [HENRY SCHEIN, INC.]	6
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	A AND D (PETROLATUM) OINTMENT [HENRY SCHEIN, INC.]	6
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	A AND D (PETROLATUM) OINTMENT [HENRY SCHEIN, INC.]	6

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 59 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ivarest	ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE	Blistex Inc	6f68cbbb-6269-4bb3-8cc9-50b146703b42	2024-07-09	Warnings	Exact identifier application number: M016
Best Choice Diaper Rash	ZINC OXIDE	Trifecta Pharmaceuticals USA LLC	1be37841-e0a8-a0de-e063-6294a90a9eb1	2024-06-27	Warnings	Exact identifier application number: M016
Gas Relief Ultra Strength	SIMETHICONE	Walgreens	00a9164a-1817-4130-9c7f-9f5833c9690f	2024-06-26	Warnings	Exact identifier application number: M016
Astonea Skin Protectant	ZINC OXIDE	ASTONEA LABS PRIVATE LIMITED	e3c7a515-3e77-da85-e053-2995a90a3ee1	2024-06-25	Warnings	Exact identifier application number: M016
Astonea Vitamin A and D	WHITE PETROLATUM	ASTONEA LABS PRIVATE LIMITED	ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf	2024-06-25	Warnings	Exact identifier application number: M016
ZOEY NATURALS DIAPER Cream	ZINC OXIDE	Absolutely Natural	70fac4d6-8833-4799-b6b6-796f8f13f80e	2024-06-25	Warnings	Exact identifier application number: M016
Medicated Body	MENTHOL AND ZINC OXIDE	Universal Distribution Center LLC	2a59a847-cc7a-42cf-b49a-92e7254c1629	2024-06-19	Warnings	Exact identifier application number: M016
THERA Moisturizing Body Shield	DIMETHICONE	McKesson Medical-Surgical Inc.	56869b64-11ee-4df6-8102-ce5818e0116e	2024-06-18	Warnings	Exact identifier application number: M016
Dimethicone	SKIN PROTECTANT	McKesson	96886b33-44d4-5a2a-e053-2a95a90a505e	2024-06-18	Warnings	Exact identifier application number: M016
Derma E Eczema Relief	OATMEAL	derma e	767c4a76-8ccb-4530-9b4b-a7ea1a596c7f	2024-06-18	Warnings	Exact identifier application number: M016
Insect sting relief pad 01	SODIUM BICARBONATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	1b0f0088-6482-6de7-e063-6294a90aeeb7	2024-06-17	Warnings	Exact identifier application number: M016
THERA Calazinc Body Shield	ZINC OXIDE	McKesson Medical-Surgical Inc.	974b1046-83ee-4207-91d3-40982beb9c63	2024-06-17	Warnings	Exact identifier application number: M016
Dimethicone	BODY CLEANSER	McKesson	8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a8	2024-06-14	Warnings	Exact identifier application number: M016
Dr. Mom Butt Balm	DIMETHICONE PETROLATUM	Ferndale Laboratories, Inc.	ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd	2024-06-13	Warnings	Exact identifier application number: M016
Secura Protective	PETROLATUM	Smith & Nephew Medical Ltd	20906566-fbf2-46d9-a5d8-c7f7356d1080	2024-06-12	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	NuCare Pharmaceuticals,Inc.	66e98554-e158-a519-e053-2a91aa0a6783	2024-06-06	Warnings, Adverse reactions	Exact identifier application number: M016
CVS Health Vitamin A and D Skin Protectant	LANOLIN AND PETROLATUM	CVS Health	fe3ccabb-9644-4091-9dca-ffd96a43ecaf	2024-05-28	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash	ZINC OXIDE	Babo Botanicals, Inc.	186a9642-cd73-adfb-e063-6394a90a75c7	2024-05-14	Warnings	Exact identifier application number: M016
Honest Eczema Balm	COLLOIDAL OATMEAL	The Honest Company, Inc.	35b8bc5c-420e-4d31-9659-f36cabbd897a	2024-05-14	Warnings	Exact identifier application number: M016
Extra Strength Itch Stopping	ITCH STOPPING CREAM	Universal Distribution Centre LLC	b9a42aa3-1903-76f0-e053-2a95a90a51d1	2024-05-13	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-0375-47	00404037547	144 PACKET in 1 CARTON (0404-0375-47) > 5 g in 1 PACKET (0404-0375-05)	144 packet	2011-12-04	2024-09-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS	Henry Schein, Inc. \| ULTRAtab Laboratories, Inc. \| Ultra Seal Corporation	2023-01-03	HUMAN OTC DRUG LABEL	10