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		2026-10-12
excluded package	package	50157-477	50157-477-18	I	Inactivated by FDA		2026-10-12

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 4 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Petroleum Jelly, Lil Drug Store	PETROLATUM JELLY	Lil' Drug Store Products, Inc.	5862af40-97e2-d792-e063-6394a90a0f1a	2026-08-06	Warnings	Exact identifier application number: M016
AOAO RAPID ACNE RELIEF	SALICYLIC ACID,BENZOYL PEROXIDE	Guangzhou Senmai Biotechnology Co.,Ltd.	586df874-0f71-ed46-e063-6294a90a0a8e	2026-08-06	Warnings	Exact identifier application number: M016
Dealmed Vitamins A and D	WHITE PETROLATUM	Dealmed Medical Supplies, LLC.	d6584809-b438-4b2c-ab37-522e0dbef470	2026-08-05	Warnings	Exact identifier application number: M016
Dealmed Vitamins A and D	PETROLATUM	Dealmed Medical Supplies, LLC.	84afe4ae-f9e8-406f-9fbe-f413975f86eb	2026-08-05	Warnings	Exact identifier application number: M016
Petroleum Jelly	PETROLATUM	Walgreens	1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f5	2026-08-04	Warnings	Exact identifier application number: M016
Nail Treatment Repairing Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	57b8b3e5-88be-3a91-e063-6294a90a05be	2026-08-03	Warnings	Exact identifier application number: M016
PROCURE	ZINC OXIDE	TWIN MED, LLC	e68ae97e-668e-31c2-e053-2995a90ab4d3	2026-08-03	Warnings	Exact identifier application number: M016
PROCURE VITAMIN A AND D Skin Protectant	PETROLATUM	TWIN MED, LLC	bbbca68e-1b65-49b1-a5fa-ed4da55d05e3	2026-08-03	Warnings	Exact identifier application number: M016
procure	PETROLATUM	TWIN MED, LLC	32520d8f-91ee-47a1-9129-bf0746791f4b	2026-08-03	Warnings	Exact identifier application number: M016
ProCure HydroShield	PETROLATUM 44.28%	Twin Med LLC	3ab7bfb2-bbcf-0822-e063-6294a90af084	2026-08-03	Warnings	Exact identifier application number: M016
456 Acne Relief Cream	NIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOT	Guangzhou Senmai Biotechnology Co.,Ltd.	5830fd36-0613-1980-e063-6294a90adfb7	2026-08-03	Warnings	Exact identifier application number: M016
Crogooe Skin Relief Cream	COLLOIDAL OATMEAL	Guangdong Outeli Biotechnology Co., Ltd.	57f9b3e8-25d3-2b20-e063-6394a90aaea5	2026-08-01	Warnings	Exact identifier application number: M016
First Aid Beauty Sensitive Skin Bestsellers Kit	COLLOIDAL OATMEAL	JCS Global Distribution, Inc.	57c3556a-aad3-3e65-e063-6394a90ab689	2026-07-29	Warnings	Exact identifier application number: M016
DERMFREE INSECT BITE RELIEF	SODIUM BICARBONATE 5% INSECT BITE RELIEF	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5794886c-0d74-9f35-e063-6394a90a27d8	2026-07-27	Warnings	Exact identifier application number: M016
OKeeffes Lip Repair SEAL and HEAL	PETROLATUM	The Gorilla Glue Company/O'Keeffe's Company	55f66f54-da39-76c7-e063-6394a90aeda9	2026-07-27	Warnings	Exact identifier application number: M016
ATTITUDE Baby Leaves Diaper cream - Unscented	ZINC OXIDE	9055-7588 Quebec Inc. (Attitude)	579aa481-f8ec-b263-e063-6394a90a7754	2026-07-27	Warnings	Exact identifier application number: M016
Boo Boo Magic Diaper Rash Creamy	ZINC OXIDE	Alboo Brands LLC	5114aff8-adde-e610-e063-6294a90a77ea	2026-07-27	Warnings	Exact identifier application number: M016
PrevaDRM Vitamin Repair	SKIN PROTECTANT	Sion Brands LLC	579e4639-a742-1901-e063-6294a90a2d45	2026-07-27	Warnings	Exact identifier application number: M016
Hello Bello Diaper Rash Cream	ZINC OXIDE	Topiderm, Inc.	e158ba31-e159-4624-a490-fe70baaf4a39	2026-07-24	Warnings	Exact identifier application number: M016
Gethorey Vein Target Microneedle Patch	ALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57593145-a874-15d9-e063-6294a90a77d9	2026-07-24	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