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 35 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Witch HazelWITCH HAZELMeijer Distribution Inc03f23b04-e7f7-49b7-e063-6294a90ad58a2025-10-31WarningsExact identifier
application number: M016
Diaper Rash skin protectantLANOLIN AND PETROLATUMUniversal Distribution Centre LLC1852246a-6a1c-49ab-e063-6294a90a90482025-10-30WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b531c1-9ab0-5ff1-e063-6394a90a29752025-10-30WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b650bd-18fe-8696-e063-6394a90aa9a22025-10-30WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b5f354-3379-3d9f-e063-6294a90ae8172025-10-30WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.59d90652-a471-4f77-a3d5-88aad9dc9e132025-10-30WarningsExact identifier
application number: M016
CVS Cools Itch FastHYDROCORTISONECVS Pharmacy, Inc.8a4544df-bbba-47d2-ada0-352757abc91f2025-10-29WarningsExact identifier
application number: M016
Winco Maximum Strength HydrocortisoneHYDROCORTISONEWINCO FOODS, LLCb1812ea3-78cc-607a-e053-2a95a90a0a102025-10-29WarningsExact identifier
application number: M016
Good Neighbor Pharmacy Skin ProtectantZINC OXIDEAMERISOURCE BERGENc28e63f1-34be-9206-e053-2995a90accf62025-10-29WarningsExact identifier
application number: M016
Remedy NutrashieldDIMETHICONEMedline Industries, LPed8a08a7-594c-46e2-b70f-b75b2960141f2025-10-28WarningsExact identifier
application number: M016
American Red Cross Anti-ItchHYDROCORTISONE 1.0%(W/W)MY IMPORTS USA LLC421da126-a1c4-54d7-e063-6394a90ac4012025-10-27WarningsExact identifier
application number: M016
GeriGardZINC OXIDEGeri-Gentle Corporation05b67830-adc8-46b1-b0a0-a6cd2875e80c2025-10-27WarningsExact identifier
application number: M016
Boudreauxs Butt BarrierDIMETHICONEC.B. Fleet Company, Inc.06a5af4d-40dd-42a4-8368-4d6a772d1b3a2025-10-27WarningsExact identifier
application number: M016
Boudreauxs Baby Shower BundleZINC OXIDEC.B. Fleet Company, Inc.a289ed3c-3c7a-4eda-bf5e-139203d2e17e2025-10-27WarningsExact identifier
application number: M016
WinCo Original Strength Anti-ItchDIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATEWinCo Foods, LLCae74e163-ba1a-4d1e-aaeb-9976bd2026742025-10-24WarningsExact identifier
application number: M016
Maximum Strength Moisture BarrierPETROLATUM AND ZINC OXIDEDerma Sciences Canada Inc.41ee91c0-d196-cc0f-e063-6394a90a7b972025-10-24WarningsExact identifier
application number: M016
TenderphorSKIN PROTECTANTGERI-GENTLE CORPORATIONe6763da3-cbd1-7a86-e053-2995a90a26c12025-10-23WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.262278f6-7e4c-44ee-b40d-39662a239d732025-10-23WarningsExact identifier
application number: M016
American Red Cross Anti-ItchHYDROCORTISONE 1.0%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41b8cb00-a04e-52f0-e063-6294a90aabf72025-10-22WarningsExact identifier
application number: M016
WinCo Foods Hydrocortisone Cream Intensive HealingHYDROCORTISONEWINCO FOODS, LLCac4e0e24-9295-b83b-e053-2995a90a996f2025-10-22WarningsExact 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