FDA.reportPublic FDA data

First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant

Product NDC
84126-045
11-digit product format
841260045
Labeler code
84126
Product ID
84126-045_4c37b1d2-abaf-4a15-e063-6394a90a7970
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
CREAM
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-01
Substance
DIMETHICONE
Active strength
1 g/100g
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
276c68d4-e273-4e48-e063-6294a90ab16fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-045-01First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant1 in 1 CARTONCREAM15
84126-045-01First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant63.7 g in 1 TUBECREAM63.75
84126-045-02First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant2 g in 1 POUCHCREAM25
84126-045-10First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant10 g in 1 TUBECREAM105
84126-045-30First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant30 g in 1 TUBECREAM305
84126-045-63First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant63.7 g in 1 TUBECREAM63.75

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-045FIRST AID BEAUTY FAB ULTRA REPAIR RESCUE BARRIER BALM SKIN PROTECTANT (DIMETHICONE) CREAM [THE PROCTER & GAMBLE MANUFACTURING COMPANY]3Current NDC, 6 package rows20250305_276c68d4-e273-4e48-e063-6294a90ab16f.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 14 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChapStick Classic Variety Cherry-Strawberry-SpearmintSKIN PROTECTANT LIP BALMSuave Brands Co., LLC450e46d2-de86-e5fa-e063-6294a90ac6ff2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic OriginalSKIN PROTECTANT LIP BALMSuave Brands Co., LLC4512220a-9fc2-8816-e063-6394a90a9d152026-03-30WarningsExact identifier
application number: M016
ChapStick Classic Original MilitarySKIN PROTECTANT LIP BALMSuave Brands Co., LLC45136b7e-136b-0283-e063-6394a90a599a2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic Variety-Classic Cherry-Classic Strawberry-Classic SpearmintSKIN PROTECTANT LIP BALMSuave Brands Co., LLC4523af69-1a0d-6d18-e063-6394a90ad9d12026-03-30WarningsExact identifier
application number: M016
ChapStick Sweet Valetine Berry Much Besties, Mint To Be, Cherish Me CherryLIP BALM SKIN PROTECTANTSuave Brands Company47a2487d-b2e5-7195-e063-6394a90ae4812026-03-30WarningsExact identifier
application number: M016
ChapStick Classic CherrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC4512b5a0-ce1f-c53e-e063-6294a90a56b62026-03-30WarningsExact identifier
application number: M016
ChapStick Classic StrawberrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC42770fff-d70a-d9d1-e063-6294a90aa98d2026-03-30WarningsExact identifier
application number: M016
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
application number: M016
Critic Aid ClearPETROLATUMColoplast Corp0b6da97e-519b-4579-9895-f4ede5c48b472026-03-27WarningsExact identifier
application number: M016
Baza ProtectZINC OXIDE AND DIMETHICONEColoplast Corp256dfcfc-a91c-49b0-9439-452586a0880e2026-03-27WarningsExact identifier
application number: M016
Sween 24DIMETHICONEColoplast Corpa623c8d7-8db0-410a-9980-02ac02f7b6ea2026-03-27WarningsExact identifier
application number: M016
Baza Cleanse and Protect Odor ControlDIMETHICONEColoplast Corpca5fa4ae-c18d-4457-b520-4a9318ea821f2026-03-27WarningsExact identifier
application number: M016
Baza Cleanse and ProtectDIMETHICONEColoplast Corp82eff041-0c9d-4261-a6b6-5a041a6600742026-03-27WarningsExact identifier
application number: M016
Baza ClearPETROLATUMColoplast Corp69d9f456-1a35-4146-8366-c0285648a1722026-03-27WarningsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMTopco Associates LLC5126fdf6-5df5-474b-bc0d-3a82dea61abb2026-03-26Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMAmazon.com Services LLCcdf1bd12-ac59-4f06-be0f-ef6eb3caeeff2026-03-26Warnings, Adverse reactionsExact identifier
application number: M016
Dynashield with DimethiconeZINC OXIDEDynarex Corporationb5dcf9e8-4689-4a08-ae73-3a859b4cbffe2026-03-26WarningsExact identifier
application number: M016
Eczema Relief CreamCOLLOIDAL OATMEALLavior Pharma Incbdd2fc9f-2718-1d88-e053-2995a90a86822026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f2dec8-7ffc-fc3e-e063-6294a90a76ff2026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f33001-7fec-682e-e063-6394a90a94282026-03-26WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
84126-045-01841260045011 TUBE in 1 CARTON (84126-045-01) / 63.7 g in 1 TUBE1 tube2026-02-01NoNoCurrent
84126-045-02841260045022 g in 1 POUCH (84126-045-02) 2 g2024-12-012026-12-01YesNoHistorical
84126-045-108412600451010 g in 1 TUBE (84126-045-10) 10 g2024-12-01NoNoCurrent
84126-045-308412600453030 g in 1 TUBE (84126-045-30) 30 g2024-12-01NoNoCurrent
84126-045-638412600456363.7 g in 1 TUBE (84126-045-63) 63.7 g2024-12-012026-12-01NoNoHistorical