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 40 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EIGHT HOUR SKIN FRAGRANCE FREEPETROLATUMREVLONb61d6e2e-18dd-37d2-e053-2a95a90af57b2025-08-01WarningsExact identifier
application number: M016
Vigority Wild Yam CreamESTRIOL CREAMFOUNDATION COMMERCE INC39b2bef7-46c5-9ad5-e063-6294a90ae9832025-07-30WarningsExact identifier
application number: M016
Rugby Caldyphen ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONRugby Laboratories9af3a740-ef97-26ce-e053-2a95a90a0ee12025-07-28WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy Soothing Bath TreatmentOATMEALKenvue Brands LLCe7eb10b7-3950-49cb-ba73-11e7581b6be92025-07-25WarningsExact identifier
application number: M016
ProCure SkinGuardPETROLATUM 49.9%Twin Med LLC3a1721f6-1bb0-cd47-e063-6394a90a148e2025-07-25WarningsExact identifier
application number: M016
ProCure HydroCerinPETROLATUM 33%Twin Med LLC3ab7248d-b914-9fdd-e063-6294a90ac4c82025-07-24WarningsExact identifier
application number: M016
AD PREVENT OriginalAD PREVENT ORIGINALWellSpring Pharmaceutical Corporationcf73246e-81c1-42e9-a107-dc6c99cf7d012025-07-24WarningsExact identifier
application number: M016
Dimethicone 1 Skin ProtectantDIMETHICONEUniversal Distribution Center LLC2c5b96b9-24d6-4223-a63d-fe83d7c023682025-07-24WarningsExact identifier
application number: M016
Dr Butlers Soothing IncontinenceMINERAL OIL 59.8%, PETROLATUM 36.0%Beyond Health PA3a9d3796-fd05-fe57-e063-6294a90a0ac62025-07-23WarningsExact identifier
application number: M016
A and D plus EVITAMIN A, D AND E OINTMENTDerma Sciences Canada Inc.35aca592-bfd0-652f-e063-6394a90ac53e2025-07-22WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMDerma Sciences Canada Inc.3a895e6c-da8d-db9b-e063-6394a90ace402025-07-22WarningsExact identifier
application number: M016
Petroleum JellyPETROLEUM JELLYNeilMed Pharmaceuticals Inc.36bbbb1e-78e9-98f6-e063-6294a90a66d12025-07-21WarningsExact identifier
application number: M016
Mountain Ice EczemaCOLLOIDAL OATMEALMountainside Medical Equipment, Inc.1a91f33e-dd85-4d5a-b61c-e460a507e2922025-07-21WarningsExact identifier
application number: M016
Our Eczema RemedyCOLLOIDAL OATMEALFewer Better Things3a755b4c-47c8-9ca5-e063-6394a90af84a2025-07-21WarningsExact identifier
application number: M016
Aveeno DAILY MOISTURIZINGDIMETHICONEKenvue Brands LLC54a13b85-32b5-439d-a27a-8fba2cf442512025-07-16WarningsExact identifier
application number: M016
ProCure Moisture Barrier1% DIMETHICONE, 12% ZINC OXIDETwin Med LLC3988c83b-d4eb-1f09-e063-6394a90a45ad2025-07-14WarningsExact identifier
application number: M016
Avalon Organics Antidandruff ConditionerSALICYLIC ACIDThe Hain Celestial Group, Inc.66db1071-022a-aa19-e053-2a91aa0a8e392025-07-11WarningsExact identifier
application number: M016
Avalon Organics AntidandruffSALICYLIC ACIDThe Hain Celestial Group, Inc.66c7f730-64f3-4eef-e053-2a91aa0a42252025-07-11WarningsExact identifier
application number: M016
terrasil Infection Protection Wound Care Maximum StrengthALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions9e7843e2-ca69-40f5-a4ce-da6b03ebe7f72025-07-11WarningsExact identifier
application number: M016
terrasil Skin RepairALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions92a23c7f-6b89-49cb-93e2-49ab7a85c86d2025-07-11WarningsExact 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