Sheffield Advanced Scar Gel

Product NDC
11527-725
11-digit product format
115270725
Labeler code
11527
Product ID
11527-725_b6c2d6dd-7354-4573-b34c-bd22abc7f355
Type
HUMAN OTC DRUG
Nonproprietary name
Advanced Scar Gel
Dosage form
GEL
Route
TOPICAL
Labeler
Sheffield Pharmaceuticals LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-14
Substance
ALLANTOIN
Active strength
5 mg/g
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
Sheffield Advanced Scar Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN5 mg/g

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
ab78b946-81ed-442c-a167-26c26c7fe8a1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-725-07Sheffield Advanced Scar Gel20 g in 1 TUBEGEL202
11527-725-07Sheffield Advanced Scar Gel1 in 1 CARTONGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-725SHEFFIELD ADVANCED SCAR GEL (ADVANCED SCAR GEL) GEL [SHEFFIELD PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 2 package rows20231201_ab78b946-81ed-442c-a167-26c26c7fe8a1.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 45 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIVAGEN ZINC OXIDEZINC OXIDENivagen Pharmaceuticals, Inc.7b42655b-2163-4637-9f5d-1d2efa1bdf1d2025-02-03WarningsExact identifier
application number: M016
MATYS Baby ECZEMA RELIEFCOLLOIDAL OATMEALMatys Healthy Products LLC4c052bed-0931-4b8d-b033-b1872272c5982025-01-29WarningsExact identifier
application number: M016
MATYS Baby DIAPER RASH RELIEFZINC OXIDEMatys Healthy Products LLCf214db72-bf4f-46d7-8ffc-6333185a69d52025-01-29WarningsExact identifier
application number: M016
EARLY MOMMY Baby Bum ButtaZINC OXIDETEKT TONE LABS LLC4bd417ba-3d24-46e3-a771-3183824f02192025-01-28WarningsExact identifier
application number: M016
Rite Aid ScarALLANTOIN 0.5%Rite Aidfd152c8f-6df5-1236-e053-6394a90a865d2025-01-27WarningsExact identifier
application number: M016
BIA Eczema ReliefOATMEALCodex Labs Corporation2f2de819-b7db-4c1e-9d6e-9ce33f7e6d052025-01-27WarningsExact identifier
application number: M016
Geri-Gentle petrolatumWHITE PETROLATUMGeri-gentle corporation0adfbb9e-173c-925a-e063-6394a90aeb5d2025-01-25WarningsExact identifier
application number: M016
Royal Creamy Petroleum Jelly Cocoa ButterPETROLATUM JELLYMission Series Inc. dba Prestige Beauty Careaca24d5e-42ee-1606-e053-2a95a90ab4e62025-01-23WarningsExact identifier
application number: M016
Royal Creamy Petroleum JellyPETROLATUM JELLYMission Series Inc. dba Prestige Beauty Carea903becc-443d-284b-e053-2a95a90a6c752025-01-23WarningsExact identifier
application number: M016
Pharmacys Prescription Petroleum JellyPETROLATUMAmerican Consumer Products Corpc4d29ecb-bb00-cb0b-e053-2995a90a37ef2025-01-23WarningsExact identifier
application number: M016
Baby XtraCare OatmealDIMETHICONERejoice International0049462b-ff31-440f-9244-b61153625bca2025-01-23WarningsExact identifier
application number: M016
Repair and ProtectPETROLATUMBlistex Inc.a51e1b67-e2c7-4b67-95db-07f5f3bdc0682025-01-23WarningsExact identifier
application number: M016
Bebe BottomsZINC OXIDETARO PHARMACEUTICALS U.S.A., INC.eb8512db-f8a9-432c-8779-2971411ce43d2025-01-21WarningsExact identifier
application number: M016
Johnsons First Touch Baby Gift SetZINC OXIDEKenvue Brands LLC2c2337cf-4507-7232-e063-6294a90a79c32025-01-20WarningsExact identifier
application number: M016
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLC1ac59efd-9efd-09d9-e063-6394a90a5e402025-01-20WarningsExact identifier
application number: M016
Hand Sanitizer WipesALCOHOLHANUL CO.,LTDa3424b96-74b0-21c4-e053-2a95a90ae7ea2025-01-20WarningsExact identifier
application number: M016
Hand Sanitizer WipesALCOHOLHANUL CO.,LTDa4eb1cad-a9c0-43d3-e053-2995a90a06a02025-01-20WarningsExact identifier
application number: M016
RICO Hand Sanitizer WipesALCOHOLHANUL CO.,LTDdc8ba3a2-9748-ec52-e053-2995a90a638b2025-01-20WarningsExact identifier
application number: M016
Hand SanitizerALCOHOLHANUL CO.,LTDa4fa65f9-9786-76dd-e053-2995a90a6e132025-01-20WarningsExact identifier
application number: M016
SAN Skinlab Cloth Wet WipesBENZALKONIUM CHLORIDE 0.13%HANUL CO.,LTDc058d278-3d6d-7e3c-e053-2995a90a6c2f2025-01-20WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1442087allantoin 0.5 % Topical GelPSNab78b946-81ed-442c-a167-26c26c7fe8a12
1442087allantoin 0.005 MG/MG Topical GelSCDab78b946-81ed-442c-a167-26c26c7fe8a12
1442087allantoin 0.5 % Topical GelSYab78b946-81ed-442c-a167-26c26c7fe8a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11527-725-07115270725071 TUBE in 1 CARTON (11527-725-07) / 20 g in 1 TUBE1 tube2021-10-140000-00-00NoNoCurrent