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		2026-10-16
excluded package	package	50157-477	50157-477-18	I	Inactivated by FDA		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 · 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 42 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
terrasil Diabetics Ulcer and Sore Relief	ALLANTOIN	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	fd6bf169-f1e2-48d4-b98d-8f3c39981a89	2025-05-23	Warnings	Exact identifier application number: M016
Perfect 10 Soothing Recovery	PETROLATUM	Topiderm, Inc.	e3a4f038-d084-4d77-bd35-13f41856a615	2025-04-30	Warnings	Exact identifier application number: M016
Diabetic Advanced Healing Cream	DIMETHICONE	Neoteric Cosmetics, Inc.	46996845-9398-41d8-bf99-79f6a29bec28	2025-04-30	Warnings	Exact identifier application number: M016
BabyDiaperCream	BABY DIAPER CREAM	Whole Foods Market	d7b19529-d0b2-638b-e053-2a95a90acf2f	2025-04-29	Warnings	Exact identifier application number: M016
ChapIce Moisture SPF 15 Lip Balm	OXYBENZONE, OCTINOXATE, PETROLATUM	Navajo Manufacturing Company Inc.	60ce1a8c-180a-161e-e053-2991aa0ae981	2025-04-29	Warnings	Exact identifier application number: M016
Assurance Barrier Cream	DIMETHICONE CREAM	Walmart Inc	23a2a04f-71ce-4fa1-e063-6394a90a649e	2025-04-22	Warnings	Exact identifier application number: M016
Aveeno Baby Eczema Therapy Moisturizing	OATMEAL	Kenvue Brands LLC	21d2c0a0-70c3-7fd3-e063-6394a90a46d4	2025-04-18	Warnings	Exact identifier application number: M016
Secura Extra Protective	ZINC OXIDE	Smith & Nephew Medical Ltd	499a1944-1682-4798-9058-3748a5eaa420	2025-04-17	Warnings	Exact identifier application number: M016
Firming Care Gel	FIRMING CARE GEL	Guangzhou Jiaan Cosmetics Co.,Ltd.	32cb8a71-81cd-cdbd-e063-6394a90ac07f	2025-04-15	Warnings	Exact identifier application number: M016
Baby Mantra Diaper Cream	ZINC OXIDE 10%	Renu Laboratories, LLC	0427bbc9-f4c0-0eb6-e063-6294a90a7199	2025-04-14	Warnings	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	TOP CARE (Topco Associates LLC)	23b592f7-3af3-45ef-897a-fe33ab518b6d	2025-04-14	Warnings	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Strategic Sourcing Services LLC	ef3408db-de98-4a43-9215-f80fed14815c	2025-04-14	Warnings	Exact identifier application number: M016
Petroleum Jelly	PETROLATUM	Walgreens	69bdd508-7c33-42c5-9a08-e56cf3eaebf3	2025-04-11	Warnings	Exact identifier application number: M016
4% 10gTATTOO Numb Cream	4% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	322daa32-a74e-1fee-e063-6294a90a37aa	2025-04-07	Warnings	Exact identifier application number: M016
Aluroderm Scar	ALLANTOIN	Asclemed USA, Inc.	60656ca1-5218-4595-854e-19f1061def1e	2025-04-01	Warnings	Exact identifier application number: M016
Dr. Maxs Diaper	ZINC OXIDE	Dr. Maxs LLC	31bfa962-5e3b-c5d2-e063-6294a90ac177	2025-04-01	Warnings	Exact identifier application number: M016
Vaseline	BABY HEALING JELLY	Conopco Inc. d/b/a Unilever	bca3176f-86fe-5969-e053-2995a90a2419	2025-03-31	Warnings	Exact identifier application number: M016
4% TATTOO Numb Cream	4% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	31646815-f591-c560-e063-6294a90ad11a	2025-03-28	Warnings	Exact identifier application number: M016
Face Saver Gel	SKIN PROTECTANT GEL	Neat Feat Products Limited	31563dd7-9f58-80f6-e063-6294a90a5571	2025-03-27	Warnings	Exact identifier application number: M016
Porphose	COLLOIDAL OATMEAL TOPICAL SPRAY	Porphose	315951e0-899f-c968-e063-6294a90abe61	2025-03-27	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