FDA.reportPublic FDA data

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct75523-200IInactivated by FDA2026-10-21
excluded packagepackage75523-20075523-200-02IInactivated by FDA2026-10-21

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 NDCProductDescriptionFormQuantityStrengthSPL version
75523-200-02Barrier Balm57 g in 1 TUBEOINTMENT572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75523-200BARRIER BALM (SKIN PROTECTANT) OINTMENT [PROJECT CHEMISTRY, INC.]2Legacy NDC, 1 package rows20231030_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 37 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
The Zoeun Skin Nourishing CreamCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42849f5c-a983-c3ce-e063-6394a90a2fb52025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon Body WashCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.4285320a-bf0b-915d-e063-6394a90a9cfd2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon GelCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42859de3-15dd-c7b9-e063-6394a90af5012025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon Hair EssenceCOLLOIDAL OATMAELSturgeonbio Co.,Ltd.4285eb13-d1a2-0663-e063-6294a90ac40f2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Total Care CreamCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.428643c3-e932-4db5-e063-6294a90ac36c2025-10-01WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEGeri-Gentle Corporationf5cfab62-8aab-4109-b15b-4fe380f7cb9e2025-09-29WarningsExact identifier
application number: M016
GoodSense Petroleum JellyWHITE PETROLATUMGOOD SENSE3492f044-250e-45f7-8638-e3c55713e0f52025-09-29WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy MoisturizingOATMEALKenvue Brands LLC2a028465-1dff-4ae7-abf6-7521c2784dd12025-09-26WarningsExact identifier
application number: M016
Johnsons Baby First Touch Gift SetZINC OXIDEKenvue Brands LLC3f838eb7-42a3-c96b-e063-6294a90a74912025-09-26WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly OriginalWHITE PETROLATUMVeridian Healthcare1fb96a6c-7d13-4ccf-8fa6-55ec79e6877c2025-09-25WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly Baby FreshWHITE PETROLATUMVeridian Healthcare0d3e6c1a-3ba9-4442-bae0-27312d658d072025-09-25WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly Cocoa ButterWHITE PETROLATUMVeridian Healthcare5c7d9eb6-c129-4fd9-9671-2e0f0453fd282025-09-25WarningsExact identifier
application number: M016
SKIN TAG REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD3ee79d66-e728-48dd-e063-6394a90a64632025-09-16WarningsExact identifier
application number: M016
ProCure LanaCareLANOLIN 50%Twin Med LLC3aabd4ea-107c-a02c-e063-6294a90aee072025-09-15WarningsExact identifier
application number: M016
ProCure LanaCareLANOLIN 30%Twin Med LLC3aad8395-6dc2-f600-e063-6294a90a6e9a2025-09-15WarningsExact identifier
application number: M016
ProCure DryDroxALUMINUM HYDROXIDE GEL 2%Twin Med LLC3ab4efb6-bd31-2583-e063-6294a90a415b2025-09-15WarningsExact identifier
application number: M016
ProCure Petroleum100% WHITE PETROLATUMTwin Med LLC3eddf0e7-8e9d-a311-e063-6394a90ad1562025-09-15WarningsExact identifier
application number: M016
NOURISHING HAND SANITIZER SPRAYSCHLORHEXIDINE DIGLUCONATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3e95a30c-8ed3-30ed-e063-6294a90a24172025-09-12WarningsExact identifier
application number: M016
I.C. Ivy BlockZINC ACETATER & R Lotion, Incdb263f4a-56a1-432c-b2e8-2a9bdd3ff1292025-09-10WarningsExact identifier
application number: M016
RoyceDerm Eczema Relief CreamCOLLOIDAL OATMEAL 1%RoyceDerm LLC3e09f000-01d2-0d21-e063-6294a90ac5482025-09-05WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245663zinc oxide 15 % Topical OintmentPSNea608b09-a043-7457-e053-2995a90a48af2
245663zinc oxide 0.15 MG/MG Topical OintmentSCDea608b09-a043-7457-e053-2995a90a48af2
245663zinc oxide 15 % Topical OintmentSYea608b09-a043-7457-e053-2995a90a48af2
245663ZNO 0.15 MG/MG Topical OintmentSYea608b09-a043-7457-e053-2995a90a48af2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75523-200-027552302000257 g in 1 TUBE (75523-200-02) 57 g2022-10-190000-00-00NoNoCurrent