FDA.reportPublic FDA data

SkinCeuticals Advanced Scar Control Skin Protectant

Product NDC
49967-783
11-digit product format
499670783
Labeler code
49967
Product ID
49967-783_ed1a7373-e1dc-4f6f-a2fc-5da01f1d3f35
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin
Dosage form
GEL
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-01
Substance
ALLANTOIN
Active strength
5 mg/mL
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
SkinCeuticals Advanced Scar Control Skin Protectant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
344S277G0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1442087Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
83f4bfbb-47d8-4fe9-ba33-85142ec6221cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-783-01SkinCeuticals Advanced Scar Control Skin Protectant1 in 1 CARTONGEL14
49967-783-01SkinCeuticals Advanced Scar Control Skin Protectant50 mL in 1 TUBEGEL504
49967-783-02SkinCeuticals Advanced Scar Control Skin Protectant4 mL in 1 TUBEGEL44
49967-783-03SkinCeuticals Advanced Scar Control Skin Protectant50 mL in 1 BOTTLEGEL504
49967-783-03SkinCeuticals Advanced Scar Control Skin Protectant1 in 1 CARTONGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-783SKINCEUTICALS ADVANCED SCAR CONTROL SKIN PROTECTANT (ALLANTOIN) GEL [L'OREAL USA PRODUCTS INC]4Current NDC, Legacy NDC, 5 package rows20241230_83f4bfbb-47d8-4fe9-ba33-85142ec6221c.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 3 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DawnMist White PetrolatumWHITE PETROLATUMDukal LLC598e9d46-6450-af60-e063-6394a90a3a6b2026-08-21WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP0073de92-585d-e01a-e063-6394a90a2ec22026-08-21WarningsExact identifier
application number: M016
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsExact identifier
application number: M016
Earths Care Hemorrhoid ReliefWITCH HAZEL AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.e860d65b-126d-4d77-8003-9d1381849ab52026-08-20WarningsExact identifier
application number: M016
ClaraViePETROLATUMGentell LLC596987e4-4205-b911-e063-6294a90aa5702026-08-19WarningsExact identifier
application number: M016
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsExact identifier
application number: M016
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
application number: M016
ClaravieLANOLINGentell LLC596c1b73-e34d-c97d-e063-6394a90ada1b2026-08-19WarningsExact identifier
application number: M016
ClaraVieMENTHOL, ZINC OXIDEGentell LLC596c467f-a056-ea78-e063-6394a90a79f22026-08-19WarningsExact identifier
application number: M016
ClaraVieLANOLINGentell LLC596fe32d-be34-0635-e063-6394a90a2fc02026-08-19WarningsExact identifier
application number: M016
MedprideZINC OXIDEShield Line LLCe2689cae-e347-4c0b-825b-6281a0b7c2f12026-08-18WarningsExact identifier
application number: M016
Eczema Skin Relief CreamCOLLOIDAL OATMEALCVS Health98fac854-f7b0-4c6e-888d-1bdc6b9323b92026-08-17WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEADUSA Distribution, LLC5940399c-31e3-6d51-e063-6294a90a8e7c2026-08-17Warnings, Adverse reactionsExact identifier
application number: M016
Intimate CareGelHYALURONIC ACIDGuangzhou Yilong Cosmetics.,Ltd5918d204-52db-e6d0-e063-6394a90ab78c2026-08-14WarningsExact identifier
application number: M016
TENA Proskin protective creamZINC OXIDEEssity HMS North America Inc.b840377f-a297-4aff-900e-7ea8b7c987172026-08-13Warnings, Adverse reactionsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP087d66ff-1a8c-dcb2-e063-6294a90a2f8c2026-08-11WarningsExact identifier
application number: M016
Nail Renewal LiquidGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.581f7192-fc17-a706-e063-6394a90a3ffa2026-08-11WarningsExact identifier
application number: M016
Intertrigo Relief CreamGLYCERINShantou South Moon Biotechnology Co., Ltd.587220c9-0ae9-3438-e063-6394a90a0a862026-08-07WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1442087allantoin 0.5 % Topical GelPSN83f4bfbb-47d8-4fe9-ba33-85142ec6221c4
1442087allantoin 0.005 MG/MG Topical GelSCD83f4bfbb-47d8-4fe9-ba33-85142ec6221c4
1442087allantoin 0.5 % Topical GelSY83f4bfbb-47d8-4fe9-ba33-85142ec6221c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-783-01499670783011 TUBE in 1 CARTON (49967-783-01) / 50 mL in 1 TUBE1 tube2021-06-010000-00-00NoNoCurrent
49967-783-02499670783024 mL in 1 TUBE (49967-783-02) 4 ml2021-06-010000-00-00NoNoCurrent
49967-783-03499670783031 BOTTLE in 1 CARTON (49967-783-03) / 50 mL in 1 BOTTLE1 bottle2021-06-01NoNoCurrent