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		2026-10-27

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 63 of 68 · 1,343 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Calamine Plus	ZINC OXIDE LOTION	Cardinal Health, 110 dba Leader	81f29789-f794-1e64-e053-2a91aa0ac85e	2023-12-22	Warnings	Exact identifier application number: M016
CVS Calamine Plus	ZINC OXIDE	CVS Pharmacy	b90cd214-d44a-4458-876d-59cc0795226d	2023-12-22	Warnings	Exact identifier application number: M016
Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Pharma Nobis, LLC	e42f0bd6-3ad3-7e07-e053-2995a90a564a	2023-12-22	Warnings	Exact identifier application number: M016
DDM Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Discount Drug Mart	5d53685b-ca4c-35c1-e053-2a91aa0aff6e	2023-12-20	Warnings	Exact identifier application number: M016
DDM Calagesic	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Discount Drug Mart	5d537a11-049e-0a8d-e053-2a91aa0aa0c3	2023-12-20	Warnings	Exact identifier application number: M016
Health Mart Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Strategic Sourcing Services LLC	349ea07d-79bc-46f3-9d60-85b40db51bbb	2023-12-20	Warnings	Exact identifier application number: M016
Health Mart Witch Hazel	WITCH HAZEL	Strategic Sourcing Services LLC	2a1d9b27-0bd4-4475-8218-ba0f5560a969	2023-12-20	Warnings	Exact identifier application number: M016
Quality Choice Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Chain Drug Market Association	62fe653f-e861-472b-b193-4fdd9d25de8d	2023-12-20	Warnings	Exact identifier application number: M016
Premier Value Calaclear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Chain Drug Consortium	5c89e3ac-ca4d-ec3a-e053-2a91aa0a1c0b	2023-12-20	Warnings	Exact identifier application number: M016
Best Choice Medicated Calamine	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Valu Merchandisers, CO.	5d6c668a-80b4-de18-e053-2991aa0a38fb	2023-12-20	Warnings	Exact identifier application number: M016
Premiere Value Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Chain Drug Consortium	5c8bde5a-591d-085f-e053-2991aa0a56af	2023-12-20	Warnings	Exact identifier application number: M016
Best Choice Anti-Itch Clear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Valu Merchandisers, CO	5d6c51b8-47f8-c38b-e053-2991aa0a0f23	2023-12-20	Warnings	Exact identifier application number: M016
Health Care Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Great Lakes Wholesale, Marketing and Sales Inc	5d8f02fb-0794-8ec2-e053-2991aa0aac63	2023-12-20	Warnings	Exact identifier application number: M016
Harris Teetter Calagesic	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Harris Tetter, LLC.	5c7a7418-c973-2869-e053-2991aa0ab4f5	2023-12-20	Warnings	Exact identifier application number: M016
Harris Teeter Calamine	ZINC OXIDE	Harris Teeter, LLC.	86021cc5-fea7-4363-8fb2-2b0484437fe8	2023-12-20	Warnings	Exact identifier application number: M016
CVS Itch Relief	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	CVS Pharmacy	c60cfbf2-6788-43dc-b23a-e3433b7f3265	2023-12-20	Warnings	Exact identifier application number: M016
Sunmark Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Strategic Sourcing Services LLC	c7467f21-56cc-43ca-abfa-e62d35c8baa6	2023-12-19	Warnings	Exact identifier application number: M016
Sunmark Witch Hazel	WITCH HAZEL	Strategic Sourcing Services LLC	08c00c1a-7ec8-4624-9db0-a0e8430cd126	2023-12-19	Warnings	Exact identifier application number: M016
Sunmark Caldyphen Clear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Strategic Sourcing Services LLC	329cd4ef-b699-46ff-a5d6-907f7c327c03	2023-12-19	Warnings	Exact identifier application number: M016
DDM Calaclear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Discount Drug Mart	5d536077-b5c6-29b8-e053-2a91aa0a9ae1	2023-12-19	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