Barrier Balm

Product NDC: 75523-200
11-digit product format: 755230200
Labeler code: 75523
Product ID: 75523-200_ea608b09-a044-7457-e053-2995a90a48af
Type: HUMAN OTC DRUG
Nonproprietary name: Skin Protectant
Dosage form: OINTMENT
Route: TOPICAL
Labeler: PROJECT CHEMISTRY, INC.
Application: M016
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-10-19
Marketing end: 0000-00-00
Substance: ZINC OXIDE
Active strength: 15 g/100g
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	75523-200		I	Inactivated by FDA		2026-10-27
excluded package	package	75523-200	75523-200-02	I	Inactivated by FDA		2026-10-27

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75523-200-02	Barrier Balm	57 g in 1 TUBE	OINTMENT	57		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75523-200	BARRIER BALM (SKIN PROTECTANT) OINTMENT [PROJECT CHEMISTRY, INC.]	2	Legacy NDC, 1 package rows	20231030_ea608b09-a043-7457-e053-2995a90a48af.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 68 of 68 · 1,343 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Badger After-BUG Balm	COLLOIDAL OATMEAL	W.S. Badger Company, Inc.	a623da47-cef2-146f-e053-2a95a90afe3a	2021-11-17	Warnings	Exact identifier application number: M016
Derma-e Eczema Relief	OATMEAL	Topiderm, Inc	e1797f81-af4b-49e1-9906-dbfd904a282b	2020-08-19	Warnings	Exact identifier application number: M016
Resurfix Plus	PETROLATUM	Topiderm, Inc.	f100f43d-6ace-4c3a-9c85-640c0ab2e360	2019-11-19	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
245663	zinc oxide 15 % Topical Ointment	PSN	ea608b09-a043-7457-e053-2995a90a48af	2
245663	zinc oxide 0.15 MG/MG Topical Ointment	SCD	ea608b09-a043-7457-e053-2995a90a48af	2
245663	zinc oxide 15 % Topical Ointment	SY	ea608b09-a043-7457-e053-2995a90a48af	2
245663	ZNO 0.15 MG/MG Topical Ointment	SY	ea608b09-a043-7457-e053-2995a90a48af	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75523-200-02	75523020002	57 g in 1 TUBE (75523-200-02)	57 g	2022-10-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ina Labs Barrier Balm	PROJECT CHEMISTRY, INC. \| Packaging On Demand, Inc.	2023-10-28	HUMAN OTC DRUG LABEL	2