Zinc Oxide 40%

Product NDC: 50157-477
11-digit product format: 501570477
Labeler code: 50157
Product ID: 50157-477_e91ff69e-84b8-ead0-e053-2995a90a752d
Type: HUMAN OTC DRUG
Nonproprietary name: Diaper Rash Skin
Dosage form: CREAM
Route: TOPICAL
Labeler: BRANDS INTERNATIONAL
Application: M016
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-09-20
Marketing end: 0000-00-00
Substance: ZINC OXIDE
Active strength: 40 g/100mL
NDC exclude flag: No
Listing certified through: 2023-12-31
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	50157-477		I	Inactivated by FDA		2026-10-15
excluded package	package	50157-477	50157-477-18	I	Inactivated by FDA		2026-10-15

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50157-477-18	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50157-477-18	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50157-477-18	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50157-477-18	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50157-477-18	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50157-477-18	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50157-477-18	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50157-477-18	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50157-477-18	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
50157-477-18	2025-01-30	C162847	48780-1	2cef2736-8e40-d83d-e063-dadaa90ab31f	Zinc Oxide 40% Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50157-477-18	Zinc Oxide 40%	118 mL in 1 TUBE	CREAM	118		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50157-477	ZINC OXIDE 40% (DIAPER RASH SKIN) CREAM [BRANDS INTERNATIONAL]	1	Legacy NDC, 1 package rows	20220921_e9201a26-46b3-477f-e053-2995a90a5e0e.zip

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 48 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TAN	ZINC OXIDE	Bentley Laboratories, LLC	7920708a-6fa7-4bc8-94ba-096e77d9d7e1	2024-12-27	Warnings	Exact identifier application number: M016
AD Medicated Rash	AD MEDICATED RASH	WellSpring Pharmaceutical Corporation	aac345bf-ea66-4f5b-a497-c24ea72f93ea	2024-12-27	Warnings	Exact identifier application number: M016
ZO Skin Health Post Procedure Recovery System	ALUMINUM ACETATE	ZO Skin Health, Inc.	3b977415-2bf4-43a9-bb48-1eb023ca4f53	2024-12-27	Warnings	Exact identifier application number: M016
terrasil Scar Recovery	ALLANTOIN	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	2a2f91ff-a447-9d2a-e063-6394a90a84f8	2024-12-26	Warnings	Exact identifier application number: M016
WITCH HAZEL	WITCH HAZEL	CHAIN DRUG MARKETING ASSOCIATION INC	bdccee3f-0ad8-4264-a65f-ae86aed6bf03	2024-12-26	Warnings	Exact identifier application number: M016
All Over Lavender Rosemary	COLLOIDAL OAT OINTMENT	Tubby Todd	29f46671-7467-95c9-e063-6294a90a1354	2024-12-23	Warnings	Exact identifier application number: M016
Sweet Cheeks Diaper Sprayer	ZINC OXIDE DIAPER PASTE SPRAY	Tubby Todd	29f4aa3c-d10e-52a5-e063-6294a90acc4b	2024-12-23	Warnings	Exact identifier application number: M016
calamine	CALAMINE AND ZINC OXIDE	WALGREEN COMPANY	fed3026b-3473-26fe-e053-6294a90a8aa2	2024-12-23	Warnings	Exact identifier application number: M016
CUREFINI	PETROLATUM, COD LIVER OIL	Miramar Cosmetics, Inc DBA Miramar Lab	fc9211db-71aa-44d8-a00b-65f1482d3981	2024-12-23	Warnings	Exact identifier application number: M016
CUREFINI	PETROLATUM	Miramar Cosmetics, Inc DBA Miramar Lab	6a2610ca-ca80-451f-8fed-b982443a10b9	2024-12-23	Warnings	Exact identifier application number: M016
Vitamin A and D	LANOLIN, PETROLATUM	Trifecta Pharmaceuticals USA LLC	453dffec-de9d-0eac-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier application number: M016
Vitamin A and D	LANOLIN, PETROLATUM	Trifecta Pharmaceuticals USA LLC	455a16fd-9ce5-6bef-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M016
White Petrolatum	PETROLATUM	Trifecta Pharmaceuticals USA LLC	f1eb0ec2-98e7-13a2-e053-2a95a90a2938	2024-12-20	Warnings	Exact identifier application number: M016
Zinc Oxide 20%	ZINC OXIDE	Pharmacy Value Alliance, LLC	38018e3f-3778-01d1-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier application number: M016
DiaperRashOintment	ZINC OXIDE	Pharmacy Value Alliance, LLC	3aace6d8-d24c-00e1-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier application number: M016
Medicated Body Powder	MENTHOL	New Pride Corp	f0f0e332-cb93-42a7-e053-2995a90ac4ae	2024-12-19	Warnings	Exact identifier application number: M016
Health Smart Medicated Body	MENTHOL AND ZINC OXIDE	International Wholesale Inc dba Home Smart Products	044870e2-ebac-a095-e063-6294a90a2751	2024-12-19	Warnings	Exact identifier application number: M016
White Rain Original Petroleum	WHITE PETROLEUM	INTERNATIONAL WHOLESALE INC.	d6ebe00c-b692-5171-e053-2a95a90a976c	2024-12-19	Warnings	Exact identifier application number: M016
Health Smart Original Petroleum	WHITE PETROLEUM	Home Smart Products	aedf746f-4c49-421d-a666-1ba02e8fb17d	2024-12-19	Warnings	Exact identifier application number: M016
white rain Cocoa Butter Petroleum Jelly	WHITE PETROLATUM	INTERNATIONAL WHOLESALE INC.	d7068e2b-c3b2-d16d-e053-2a95a90a6dd2	2024-12-19	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1305337	zinc oxide 40 % Topical Cream	PSN	e9201a26-46b3-477f-e053-2995a90a5e0e	1
1305337	zinc oxide 400 MG/ML Topical Cream	SCD	e9201a26-46b3-477f-e053-2995a90a5e0e	1
1305337	zinc oxide 40 % Topical Cream	SY	e9201a26-46b3-477f-e053-2995a90a5e0e	1
1305337	ZNO 400 MG/ML Topical Cream	SY	e9201a26-46b3-477f-e053-2995a90a5e0e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50157-477-18	50157047718	118 mL in 1 TUBE (50157-477-18)	118 ml	2022-09-20	0000-00-00	No	No	Current