FDA.reportPublic FDA data

Mederma Advanced Gel

Manufacturer
Merz North America
Effective date
2024-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:47

Label at a glance#

ProductMederma Advanced
Active ingredientALLANTOIN
Label structure1 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL - 50 mL Tube Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 46783-801-50

MEDERMA
ADVANCED GEL

50 mL

Manufactured by:
Merz Pharma GmbH & Co. KGaA
Reinheim, Germany

PRINCIPAL DISPLAY PANEL - 50 mL Tube Box Label
PRINCIPAL DISPLAY PANEL - 50 mL Tube Box Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46783-801-20Mederma Advanced20 mL in 1 TUBEGEL201
46783-801-20Mederma Advanced1 in 1 BOXGEL11
46783-801-50Mederma Advanced1 in 1 BOXGEL11
46783-801-50Mederma Advanced50 mL in 1 TUBEGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46783-801MEDERMA ADVANCED (ALLANTOIN) GEL [MERZ NORTH AMERICA]14 package rows20240316_1a96584a-1cbb-4159-9397-10cb18da1de5.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46783-80146783-801-20, 46783-801-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZACTIB
WATER059QF0KO0RIACT
EGG PHOSPHOLIPIDS1Z74184RGVIACT
XANTHAN GUMTTV12P4NEEIACT
ALCOHOL3K9958V90MIACT
SORBIC ACIDX045WJ989BIACT
METHYLPARABENA2I8C7HI9TIACT
ONION492225Q21HIACT
PANTHENOLWV9CM0O67ZIACT
POLYETHYLENE GLYCOL 200R95B8J264JIACT
HYALURONATE SODIUMYSE9PPT4THIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e6b4efec-6219-4bbe-95ac-2aa8fce422f51a96584a-1cbb-4159-9397-10cb18da1de52024-03-11Exact identifier
spl id: e6b4efec-6219-4bbe-95ac-2aa8fce422f5
spl set id: 1a96584a-1cbb-4159-9397-10cb18da1de5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.