A and D

Product NDC: 0404-0375
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0404-0375		D	Discontinued by firm		2026-10-16
excluded package	package	0404-0375	0404-0375-47	D	Discontinued by firm		2026-10-16

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 · 22 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	0404-0375-47	`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	0404-0375-47	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0404-0375-47	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0404-0375-47	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0404-0375-47	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0404-0375-47	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0404-0375-47	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0404-0375-47	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0404-0375-47	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0404-0375-47	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0404-0375-47	`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 51 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Copperlife Foot	DIMETHICONE 1%	Tommie Copper, Inc.	cb825d2c-6333-3c1f-e053-2995a90a78f3	2024-12-15	Warnings	Exact identifier application number: M016
Tommie Copper Foot	DIMETHICONE 1%	Tommie Copper, Inc.	ca3d3374-a3d4-69e5-e053-2995a90a3ece	2024-12-15	Warnings	Exact identifier application number: M016
Evereden Healing Eczema Treatment	COLLOIDAL OATMEAL	Eden Brands, Inc.	d43f0eaa-aab0-eaff-e053-2995a90ac5c8	2024-12-13	Warnings	Exact identifier application number: M016
Babo Fragrance Free Diaper Cream	ZINC OXIDE	Babo Botanicals, Inc.	adcd4fc7-c400-fc8e-e053-2a95a90a7e1f	2024-12-12	Warnings	Exact identifier application number: M016
Domeboro	ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE	Advantice Health, LLC.	28c39200-2f7c-954b-3ce7-7349b2738812	2024-12-12	Warnings	Exact identifier application number: M016
Atopis Eczema Therapy Cream	COLLOIDAL OATMEAL	Bionona Limited	8d4b4a14-b631-f2fa-e053-2a95a90a932f	2024-12-12	Warnings	Exact identifier application number: M016
Desitin Daily Defense Zinc Oxide Diaper Rash	ZINC OXIDE	Kenvue Brands LLC	b6e0d1a3-e469-4102-916b-d5cc8ca12e73	2024-12-11	Warnings	Exact identifier application number: M016
Little Me Multipurpose Baby Balm	WHITE PETROLATUM	Shalom International Corp	e09518f1-3691-4d85-a8e1-a5c452057066	2024-12-11	Warnings	Exact identifier application number: M016
Blistex Ivarest Poison Ivy Itch	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Blistex Inc.	e1eaa3e7-12ab-4b7b-b1b0-77ab07b76a2a	2024-12-11	Warnings	Exact identifier application number: M016
Deep Renewal Broad Spectrum	DIMETHICONE, AVOBENZONE, HOMOSALATE, AND OCTISALATE	Blistex Inc	11c0e084-dc40-4969-a176-3af4116d6f27	2024-12-10	Warnings	Exact identifier application number: M016
BOA VIDA Recovery Creme	DIMETHICONE	Central Solutions Inc	bfa07058-7a20-4b9f-bad1-4b9fb5c037e0	2024-12-09	Warnings	Exact identifier application number: M016
BOA VIDA Canopy	DIMETHICONE	Central Solutions Inc	44c98a3f-02f1-46ae-9fb0-1eb822b5ceaf	2024-12-09	Warnings	Exact identifier application number: M016
DermaCen Skin Protectant	ZINC OXIDE	Central Solutions Inc	990c3a65-bca5-1f0d-e053-2995a90aa7ae	2024-12-09	Warnings	Exact identifier application number: M016
BOA VIDA Calvida	ZINC OXIDE	Central Solutions Inc	48eb2031-bc80-45d5-b8b3-cc08fcab64f1	2024-12-09	Warnings	Exact identifier application number: M016
BOA VIDA Cleansing	DIMETHICONE	Central Solutions Inc	0b456b20-ab06-4adf-b5f0-1693d33979df	2024-12-09	Warnings	Exact identifier application number: M016
SOOTHE Sensitive Skin Treatment	ALLANTOIN, DIMETHICONE	Rodan & Fields	2bd8cac4-5f40-4d04-91f2-3ea8a138033b	2024-12-09	Warnings	Exact identifier application number: M016
Aveeno Eczema Therapy Rescue Relief Treatment	COLLOIDAL OATMEAL	Kenvue Brands LLC	f67e528a-b822-3f7a-e053-2995a90ae733	2024-12-06	Warnings	Exact identifier application number: M016
Humphreys Maravilla	WITCH HAZEL	Humphreys Pharmacal, Incorporated	7d403bf4-8a0d-4337-8e81-1149cd0ae1dc	2024-12-06	Warnings	Exact identifier application number: M016
Skin Soothing Cream	COLLOIDAL OATMEAL	Allure Labs Inc	9b1dfb4b-ce35-46a1-bfc6-ee5b871955f3	2024-12-05	Warnings	Exact identifier application number: M016
Skin Soothing Cream - Nut Free	COLLOIDAL OATMEAL	Allure Labs	b5eb48a5-e884-3bf6-e053-2a95a90abb97	2024-12-05	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	0000-00-00	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