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 41 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Astringent SolutionALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATEFirst Nation Group065c895c-7d86-f1ed-e063-6394a90a3a522025-07-07WarningsExact identifier
application number: M016
Creamy PetroleumPETROLATUMSavvy Care & Cosmetics Pvt Ltd3916daee-f8d2-e3f0-e063-6294a90a38832025-07-04WarningsExact identifier
application number: M016
Exemax CreamDIMETHICONE, ALLANTOINPureTek Corporation38e79055-df84-d314-e063-6394a90ac95f2025-07-01WarningsExact identifier
application number: M016
Procure Dimethicone 5%DIMETHICONETwin Med LLC38a7e4af-997d-549e-e063-6394a90a0bd62025-06-28WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDerma Sciences Canada Inc.37eff762-1ea9-ec66-e063-6394a90a3d102025-06-19WarningsExact identifier
application number: M016
Dr.Johnes SKIN TAG REMOVERSALICYLIC ACIDDr.Johnes LLCb731c55e-31ee-429f-8432-fac7c5718d832025-06-18WarningsExact identifier
application number: M016
Dr. Johne SKIN TAG REMOVERSALICYLIC ACIDDr.Johnes LLC6c5adc3c-9d45-449a-ad42-f9571851cd182025-06-18WarningsExact identifier
application number: M016
THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal OatmealOATMEALTHERAPLEX, LLCe51aa467-ffe7-4c6b-8588-6df8592596d42025-06-16WarningsExact identifier
application number: M016
ZIIDII Wild Yam CreamWILD YAMGuangzhou Haishi Biological Technology Co., Ltd.3733154a-4884-9988-e063-6294a90aa78c2025-06-10WarningsExact identifier
application number: M016
Aveeno Calm Plus Restore Skin Therapy BalmCOLLOIDAL OATMEALKenvue Brands LLCdbe7a2cc-9c21-2a48-e053-2a95a90a54e22025-06-04WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWALGREENS2017113f-d192-5fbb-e063-6294a90a83b02025-05-31WarningsExact identifier
application number: M016
AHHH Bite ReliefSODIUM BICARBONATE7827125a1e070-9228-4ec9-e063-6294a90ad78d2025-05-27WarningsExact identifier
application number: M016
SupreH Bee Venom Skin Tag Treatment LiquidSUPREH BEE VENOM SKIN TAG REMOVER LIQUIDShenzhen Xinxin Yunhai Technology Co., Ltd.35ca9836-917a-b0ac-e063-6294a90a28a22025-05-23WarningsExact identifier
application number: M016
terrasil Diabetics Ulcer and Bed Sore ReliefALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions35d2738c-dacf-7309-e063-6294a90aab4c2025-05-23WarningsExact identifier
application number: M016
terrasil Diabetics Ulcer and Sore ReliefALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionsfd6bf169-f1e2-48d4-b98d-8f3c39981a892025-05-23WarningsExact identifier
application number: M016
Perfect 10 Soothing RecoveryPETROLATUMTopiderm, Inc.e3a4f038-d084-4d77-bd35-13f41856a6152025-04-30WarningsExact identifier
application number: M016
Diabetic Advanced Healing CreamDIMETHICONENeoteric Cosmetics, Inc.46996845-9398-41d8-bf99-79f6a29bec282025-04-30WarningsExact identifier
application number: M016
BabyDiaperCreamBABY DIAPER CREAMWhole Foods Marketd7b19529-d0b2-638b-e053-2a95a90acf2f2025-04-29WarningsExact identifier
application number: M016
ChapIce Moisture SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMNavajo Manufacturing Company Inc.60ce1a8c-180a-161e-e053-2991aa0ae9812025-04-29WarningsExact identifier
application number: M016
Assurance Barrier CreamDIMETHICONE CREAMWalmart Inc23a2a04f-71ce-4fa1-e063-6394a90a649e2025-04-22WarningsExact 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