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 18 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Skin ProtectantPETROLATUMWalmart Inc.eb836922-f467-42ab-a6e7-b787d97e6c172026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalmart Inc.aa7dbf7f-50be-475b-8140-68be3fa935072026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
White PetrolatumWHITE PETROLATUMWalmart Inc.176d7711-7c4f-4319-91af-0aba1260c4122026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Soothing MoisturizingCOLLOIDAL OATMEALWalmart Inc.2d813455-c268-4c6d-9952-eaf0e0007d902026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Rapid Repair Healing CreamALLANTOIN, DIMETHICONEJune Jacobs Labs LLC186c13be-5e41-b9c9-e063-6294a90ad5742026-02-26WarningsExact identifier
application number: M016
LanashieldLANOLINDynarex Corporation94b277dc-6512-4d36-8485-8ea5100974282026-02-26WarningsExact identifier
application number: M016
GLADSKIN ECZEMACT ECZEMACOLLOIDAL OATMEALMicreos North America, Inc.06f9af75-c5ff-d37b-e063-6394a90a4f6c2026-02-25WarningsExact identifier
application number: M016
Skin Mercy Recovery CreamCOLLOIDAL OATMEALCultskin Apothecary, Inc.4bac19f3-13bb-8d18-e063-6394a90aa3932026-02-25WarningsExact identifier
application number: M016
Skin Mercy Intense Recovery CreamCOLLOIDAL OATMEALCultskin Apothecary, Inc.468f21c6-2d6f-1654-e063-6394a90ab2f52026-02-25WarningsExact identifier
application number: M016
Magnet Eye Sheet MaskEYE MASKGuangdong Bisutang Biotechnology Co., LTD4a0a84d4-4024-5ea7-e063-6394a90a2b6c2026-02-24WarningsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMFamily Dollar Stores, Incac7da793-8a39-4b47-b075-a4c4820cadad2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDFamily Dollar Stores, Inc1a03331e-3676-451c-be22-9a547e8ae6e22026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMFamily Dollar Stores, Inc7e64a424-afdb-4eb9-b6af-7b8123f1e2072026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMH E Be6154e44-d7b2-429c-9bc7-5c064220d3fb2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEH E Bf0b31d52-2903-487a-aa70-0dbdf4c4d7e72026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMH E Bff79e42c-da3f-4aec-acf4-cc26e10a1d082026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
DimethiconeDIMETHICONEH E Ba8ad595a-c811-4534-82e0-9a01085b4b1e2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALH E Bce9ffcc1-a4c3-4771-ae27-ba99c74bb1ba2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMH E B460802cc-c1b9-41cb-afe3-ca4078175efb2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMH E B2dd85211-0840-4d0d-8ba7-ea6184a509422026-02-24Warnings, Adverse reactionsExact 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