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 7 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Sosnowskis Magic Healing Multi actionCAMPHOR AND COLLOIDAL OATMEALHerstat (USA) Inc.38cd8f11-7264-a004-e063-6294a90a3a1b2026-07-03WarningsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMPublix Super Markets, Inc.c94b5574-3fd7-48a8-94ef-db5d7184fa102026-07-02Warnings, Adverse reactionsExact identifier
application number: M016
Drs. Pharmacy Baby HealingZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACY55a6981c-1b32-f448-e063-6294a90ac6d82026-07-02WarningsExact identifier
application number: M016
AVANCE ALOE INCONTINENCE CAREDIMETICONESMART CHOICE MEDICAL INC.558d239e-b0cf-c145-e063-6294a90a8a8b2026-07-01WarningsExact identifier
application number: M016
DIMETHICONE SKIN PROTECTANTDIMETHICONEVIVE HEALTH LLC5591a321-4831-1844-e063-6394a90a12d12026-07-01WarningsExact identifier
application number: M016
Drs. Pharmacy healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY55947cd9-ca25-0844-e063-6294a90a381f2026-07-01WarningsExact identifier
application number: M016
AVANCE ALOE INCONTINENCE CAREDIMETICONESMART CHOICE MEDICAL INC.55833e0f-d184-16a2-e063-6394a90acfd32026-06-30WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Summer GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company55664a0f-7d46-f002-e063-6394a90a2dc72026-06-29WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Frosted GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5566bce3-fc49-5ef4-e063-6294a90abc7a2026-06-29WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Skin Protectant Velvet PlumCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5568ada5-3ae6-3366-e063-6294a90a71192026-06-29WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Toasted CoconutCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company55698d88-aae7-c46c-e063-6394a90ad0ac2026-06-29WarningsExact identifier
application number: M016
Earth Baby Diaper Rash CreamZINC OXIDEEarth Baby, Inc42c5cf9a-0a35-5681-e054-00144ff8d46c2026-06-28WarningsExact identifier
application number: M016
ORLASKIN HYDROGEL EYE MASKALLANTOINGuangzhou Yapheon Health Industry Co., Ltd.552d072b-396f-c88a-e063-6294a90aabcd2026-06-26WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUMMedline Industries, LP3c442890-733d-8175-e063-6294a90a8b1c2026-06-24WarningsExact identifier
application number: M016
MOROVANESTRIOLHONG KONG UNORDERED TRADING CO., LIMITED54fa4308-44a4-e9dd-e063-6394a90a0cd72026-06-24WarningsExact identifier
application number: M016
EELHOE Sleep Aid PatchGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.550b0494-ca6d-c897-e063-6394a90a87512026-06-24WarningsExact identifier
application number: M016
Hair Regrowth LiquidGLYCERINShantou Woodsleep Biotechnology Co., Ltd.54e662e7-9c63-ad6b-e063-6294a90a1b8d2026-06-23WarningsExact identifier
application number: M016
RoyceDerm Eczema Relief Body WashCOLLOIDAL OATMEAL 2%RoyceDerm LLC54e74eb4-1b42-a748-e063-6394a90aeb162026-06-23WarningsExact identifier
application number: M016
Comfort Shield BarrierDIMETHICONESage Products LLCcc08f571-84ae-4c2f-b09d-a83a8efc39f52026-06-23WarningsExact identifier
application number: M016
CLEAR ANTI ITCHPRAMOXINE HCL, ZINC ACETATE LOTIONH E B54f04056-d805-8c62-e063-6394a90ab7402026-06-23Warnings, Adverse reactionsExact 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