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 17 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEOld East Main Co.91df1434-bce6-4c6e-beee-cb5ec1cc8fff2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMOld East Main Co.cf916191-1de2-4305-b783-9e074c1ad94b2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Eczema ReliefCOLLOIDAL OATMEALOld East Main Co.b2dba027-c295-4a41-8d30-144904e1aa342026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Baby Eczema TherapyCOLLOIDAL OATMEALOld East Main Co.9720e2ad-1bcf-4023-8e92-22a962df3aad2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDChain Drug Marketing Association86ff4875-9007-4b7b-8f46-16cbd475d4bb2026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEChain Drug Marketing Association1ff6bd85-3658-47ea-b6ca-0eb5d8dbb6932026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLChain Drug Marketing Association6c848b98-f01c-40f2-a9aa-2af76cb370c82026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEThe Kroger Co.fcffbe1f-79b8-451a-9384-19533b81d8c82026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMThe Kroger Co.d2095c7b-61ca-40d3-bbf1-04bed4dd789c2026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEThe Kroger Co.ea8b186c-82d5-4552-bcce-03e56023ea992026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Diaper Rash CreamZINC OXIDESmalls Brand LLC DBA Roe Wellness4bd29285-29b4-5d57-e063-6294a90af4812026-02-27WarningsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMWalmart Inc.5893801a-25e1-4750-a55b-d9cddd3f12842026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEWalmart Inc.320bcbd3-9e91-437f-99c5-066f880a4b322026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
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

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