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 12 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Herpecin Pain Relief	ALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCL	Focus Consumer Healthcare, LLC	beeb6043-6547-4fe9-e053-2995a90a5d74	2026-04-30	Warnings	Exact identifier application number: M016
CVS	PETROLATUM	Apollo Health and Beauty Care	47d2b9be-91ad-e9e2-e063-6294a90ac29f	2026-04-30	Warnings	Exact identifier application number: M016
Dr. Numb	LIDOCAINE	Shinpharma Inc	0578fbcb-875a-4606-acde-dcecb29756e6	2026-04-30	Warnings	Exact identifier application number: M016
Colloidal oatmeal	COLLOIDAL OATMEAL	Amazon.com Services LLC	423c821d-92af-47f0-b9ee-8b68ecbcc44e	2026-04-29	Warnings, Adverse reactions	Exact identifier application number: M016
MICRO INFUSIONSYSTEM	SEEK GLO	Ningbo Kenwei International Trade Co., Ltd.	50746cab-bfcc-fe0b-e063-6394a90adc01	2026-04-27	Warnings	Exact identifier application number: M016
Pharmacy Choice	MENTHOL, ZINC OXIDE	PHARMACY CHOICE INC	5031fc05-e1c7-40b1-e063-6394a90aa12c	2026-04-24	Warnings	Exact identifier application number: M016
Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTION	SEL PH BABY PH-BALANCED ECZEMA DRYNESS BABY	Guangzhou Ariel Biotech Co., Ltd.	5040b707-87af-3859-e063-6294a90afb3d	2026-04-24	Warnings	Exact identifier application number: M016
Caldesene Baby	STARCH, CORN AND ZINC OXIDE	Insight Pharmaceuticals LLC	9f12dee2-7afa-45e9-a729-0fd42bb77715	2026-04-22	Warnings	Exact identifier application number: M016
Caldesene Medicated Protecting	CORNSTARCH AND ZINC OXIDE	Insight Pharmaceuticals LLC	ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b	2026-04-22	Warnings	Exact identifier application number: M016
Arm and Hammer Baking Soda	SODIUM BICARBONATE	Church & Dwight Co., Inc.	643fe204-4a7b-00e4-e053-2a91aa0aef06	2026-04-21	Warnings	Exact identifier application number: M016
PURE PETROLATUM	PETROLATUM	MY IMPORTS USA LLC	4fba8bc7-590d-f621-e063-6294a90ad8c9	2026-04-18	Warnings	Exact identifier application number: M016
Anti-Itch Regular Strength	HYDROCORTISONE	CVS Pharmacy	9fe7768b-9023-c9ee-e053-2a95a90a55b3	2026-04-17	Warnings	Exact identifier application number: M016
Calamine Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	Pharma Nobis, LLC	4f853183-5925-2c73-e063-6394a90adf6c	2026-04-15	Warnings	Exact identifier application number: M016
Freskaro Calamine Plus	ZINC OXIDE LOTION	Pharma Nobis, LLC	4f85bdc7-8fed-f1f5-e063-6394a90a6358	2026-04-15	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE OINTMENT	Dynarex Corporation	11d79dd6-35f7-4399-e063-6294a90ac7dd	2026-04-13	Warnings	Exact identifier application number: M016
FB HYDRATING HAND SANITIZER	FB HYDRATING HAND SANITIZER	FAMILY DOLLAR SERVICES, LLC	4f261746-37e9-7b30-e063-6294a90a9224	2026-04-10	Warnings	Exact identifier application number: M016
FB HYDRATING HAND SANITIZER	FB HYDRATING HAND SANITIZER	FAMILY DOLLAR SERVICES, LLC	4f268501-6cd7-7edd-e063-6294a90ac649	2026-04-10	Warnings	Exact identifier application number: M016
BEVERLY HILLS MD HYDRARESCUE TREATMENT	DIMETHICONE	Beverly Hills MD, LLC	4ed33a43-d059-2589-e063-6294a90a30b3	2026-04-09	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	WAL-MART STORES INC	00faa772-53f3-9276-e063-6394a90a2dab	2026-04-07	Warnings	Exact identifier application number: M016
ProCure Zinc Oxide	ZINC OXIDE	Twin Med LLC	37a30ee5-fd33-b410-e063-6294a90aef72	2026-04-07	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