FDA.reportPublic FDA data

Barrier Balm

Product NDC
51514-0363
11-digit product format
515140363
Labeler code
51514
Product ID
51514-0363_01df9746-991c-4363-e063-6294a90aaac6
Type
HUMAN OTC DRUG
Nonproprietary name
Barrier Balm
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Autumn Harp, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-02
Substance
DIMETHICONE 20; PETROLATUM
Active strength
13; 41.9 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Barrier Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE 2013 g/100g
PETROLATUM41.9 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H8YMB5QY0DInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2665902Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
01df9746-991b-4363-e063-6294a90aaac6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51514-0363-1Barrier Balm15 g in 1 TUBEOINTMENT151
51514-0363-2Barrier Balm1 in 1 CARTONOINTMENT11
51514-0363-3Barrier Balm28 g in 1 TUBEOINTMENT281
51514-0363-4Barrier Balm1 in 1 CARTONOINTMENT11
51514-0363-5Barrier Balm48 g in 1 TUBEOINTMENT481
51514-0363-6Barrier Balm1 in 1 CARTONOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51514-0363BARRIER BALM OINTMENT [AUTUMN HARP, INC.]1Current NDC, 6 package rows20231229_01df9746-991b-4363-e063-6294a90aaac6.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 5 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fresh Scent PROTECTIVE BABYZINC OXIDECVS Pharmacy, Inc.3f33c62c-43ec-4576-a24d-bd5de07e74d22026-07-23WarningsExact identifier
application number: M016
DERMFREE Vein Target Microneedle PatchALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57449e29-ec46-9c30-e063-6394a90a7b4a2026-07-23WarningsExact identifier
application number: M016
Baby Vitamin A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a125ea-6f9f-310c-e063-6394a90acef22026-07-22WarningsExact identifier
application number: M016
First Aid A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a319d0-d39a-5ff0-e063-6394a90a671d2026-07-22WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
application number: M016
DermasporinLANOLINMarie's Original Formulas LLC562f40aa-eeec-2b7c-e063-6294a90ad68d2026-07-22WarningsExact identifier
application number: M016
CAREALL Vitamin A and DPETROLATUMNew World Imports, Incef89a68a-74c1-4c42-8078-b7a208ace0de2026-07-22WarningsExact identifier
application number: M016
DermactLANOLINMarie's Original Formulas LLC57121dbe-e886-a562-e063-6294a90a367f2026-07-22WarningsExact identifier
application number: M016
Universal WITCH HAZELWITCH HAZELUniversal Distribution Center LLC7e0b56ef-fa41-4862-b387-5b58d81d67d42026-07-22WarningsExact identifier
application number: M016
Aveeno Soothing Bath TreatmentOATMEALKenvue Brands LLC0c410b8e-025f-477c-afac-6e2e9ac88f7d2026-07-21WarningsExact identifier
application number: M016
DERMFREE SCAR SHEETSSILICONE GEL 1% SCAR SHEETSJiangxi Yudexi Pharmaceutical Co., LTD4a4ce316-4b92-7e81-e063-6294a90af6db2026-07-21WarningsExact identifier
application number: M016
DERMFREE VARICOSE VEINSDIMETHICONE 3% VARICOSE VEINSJiangxi Yudexi Pharmaceutical Co., LTD4a5a2d1d-9e84-18eb-e063-6394a90a97ee2026-07-21WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
application number: M016
Mederma Stretch Marks TherapyDIMETHICONEPMI Branded Pharmaceuticals, Inc.0f2918e3-9615-40e3-ab7e-6bfbe022e03c2026-07-16WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
application number: M016
DoveMEN CARE ANTIBACTERIAL CARE MOISTURIZING CREAM BARConopco d/b/a Unilever56bd6fcb-c762-4e5a-e063-6394a90a34382026-07-16WarningsExact identifier
application number: M016
Mederma Advanced ScarALLANTOINPMI Branded Pharmaceuticals, Inc.25bc1eae-3502-4c63-bd8a-43be2dfb0d6d2026-07-16WarningsExact identifier
application number: M016
Mederma Advanced ScarALLANTOINL. Perrigo Company9c3d9e08-9428-4b28-82a2-0cb24c3c92a32026-07-16WarningsExact identifier
application number: M016
aftershaveCERAMIDE NPShengnan (Guangzhou) Cosmetics Co., LTD56a17ac9-803b-932c-e063-6394a90aae902026-07-15WarningsExact identifier
application number: M016
Clear Root Labs Wound CareCRL WOUND CARE OINTMENTAidance Scientific Inc. DBA Aidance Skincare & Topicals56a6dbc7-5001-c095-e063-6294a90a1aa02026-07-15WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2665902dimethicone 13 % / petrolatum 41.9 % Topical OintmentPSN01df9746-991b-4363-e063-6294a90aaac61
2665902dimethicone 0.13 MG/MG / petrolatum 0.419 MG/MG Topical OintmentSCD01df9746-991b-4363-e063-6294a90aaac61
2665902dimethicone 13 % / petrolatum 41.9 % Topical OintmentSY01df9746-991b-4363-e063-6294a90aaac61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51514-0363-15151403630115 g in 1 TUBE15 gHistorical
51514-0363-2515140363021 TUBE in 1 CARTON (51514-0363-2) / 15 g in 1 TUBE (51514-0363-1) 1 tube2023-10-02NoNoCurrent
51514-0363-35151403630328 g in 1 TUBE28 gHistorical
51514-0363-4515140363041 TUBE in 1 CARTON (51514-0363-4) / 28 g in 1 TUBE (51514-0363-3) 1 tube2023-10-02NoNoCurrent
51514-0363-55151403630548 g in 1 TUBE48 gHistorical
51514-0363-6515140363061 TUBE in 1 CARTON (51514-0363-6) / 48 g in 1 TUBE (51514-0363-5) 1 tube2023-10-02NoNoCurrent