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 29 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TrueLipids Relieve and Protect CL MD	WHITE PETROLATUM	Claridei Laboratories, Inc.	27c0af9b-f397-dec3-e063-6394a90aed8b	2025-12-15	Warnings	Exact identifier application number: M016
Truelipids TrueLips Lip Balm CL MD	WHITE PETROLATUM	Claridei Laboratories, Inc.	27c155dc-f194-6750-e063-6394a90a20b1	2025-12-15	Warnings	Exact identifier application number: M016
Aquaphor Healing	PETROLATUM	Beiersdorf Inc	0a17bf6f-6114-4647-a509-65999255c37b	2025-12-15	Warnings	Exact identifier application number: M016
Aquaphor Original	PETROLATUM	Beiersdorf Inc	d38ec874-7b8c-4b9b-92b6-286278bb67f3	2025-12-15	Warnings	Exact identifier application number: M016
Aquaphor Healing Diaper Rash	ZINC OXIDE	Beiersdorf Inc	dec07dfc-67a2-46ad-8fab-828488bdba15	2025-12-15	Warnings	Exact identifier application number: M016
HealthWise Diabetic Foot Cream	DIMETHICONE, PETROLATUM	Veridian Healthcare	7ba0ac53-c78c-4a70-a977-a082f731919e	2025-12-15	Warnings	Exact identifier application number: M016
Aquaphor Lip Protectant and Sunscreen	PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Beiersdorf Inc	a43c2802-9cf1-477e-9f93-e11cf40b480d	2025-12-15	Warnings	Exact identifier application number: M016
Prequel Barrier Therapy Rich Skin Protectant Cream	SKIN PROTECTANT CREAM	The Center Brands, LLC	39945806-8f29-020b-e063-6294a90a9fc6	2025-12-13	Warnings	Exact identifier application number: M016
ECZEMA	COLLOIDAL OATMEAL	Smith Amish, LLC	20c4bc16-ba20-47ec-e063-6394a90a8b4e	2025-12-12	Warnings	Exact identifier application number: M016
Humco Calagesic	CALAMINE AND PRAMOXINE HYDROCHLORIDE	Humco Holding Group, Inc.	8c43590d-56ec-4588-8076-99ba94a16685	2025-12-11	Warnings	Exact identifier application number: M016
Soteri Skin Baby Eczema Relief Cream	COLLOIDAL OATMEAL	Soteri Skin, Inc	41d88ff2-22aa-8447-e063-6294a90aea0e	2025-12-10	Warnings	Exact identifier application number: M016
Soteri Skin Active Flare-Up Eczema Relief Cream	COLLOIDAL OATMEAL	Soteri Skin, Inc.	41b558d9-55ba-97ff-e063-6394a90a963b	2025-12-10	Warnings	Exact identifier application number: M016
CeraVe Developed With Dermatologist Baby Eczema Relief Cream	OATMEAL	L'Oreal USA Products Inc	5d392529-9f0c-40bc-92ca-7003f8e64b1c	2025-12-09	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Eczema Relief Moisturizing	COLLOIDAL OATMEAL	L'Oreal USA Products Inc	c4dde987-fe4e-4f8e-8f3a-1bc12c9588ed	2025-12-09	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	446ddb19-4bdb-6827-e063-6394a90a6af8	2025-12-09	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Warm Vanilla	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	45864832-51bb-4e24-e063-6294a90ab554	2025-12-09	Warnings	Exact identifier application number: M016
AquaSoothe	AQUASOOTHE	Dynarex Corporation	45878c3c-d05d-984c-e063-6294a90a4661	2025-12-09	Warnings	Exact identifier application number: M016
Soteri Skin Long-Term Eczema Relief Cream	COLLOIDAL OATMEAL	Soteri Skin, Inc	41d752cb-3866-e840-e063-6394a90acc37	2025-12-09	Warnings	Exact identifier application number: M016
Earths Care Eczema	OATMEAL	DLC Laboratories, Inc.	f72e2adf-8930-458f-a6cc-9b240b2f5eba	2025-12-08	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sparkling Grapefruit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	4575ba40-009c-26e0-e063-6394a90adee6	2025-12-08	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