Home NDC 61328-120 911
Product NDC 61328-120
11-digit product format 613280120
Labeler code 61328
Product ID 61328-120_471aac11-1c14-86fa-e063-6294a90a082e
Type HUMAN OTC DRUG
Nonproprietary name Allantoin
Dosage form OINTMENT
Route TOPICAL
Labeler Skinfix, Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-12-26
Substance ALLANTOIN
Active strength .5 g/100g
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 911
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALLANTOIN .5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 344S277G0Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1044541 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61328-120-11 911 50 g in 1 TUBE OINTMENT 50 7 61328-120-12 911 8.5 g in 1 TUBE OINTMENT 8.5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61328-120 911 (ALLANTOIN) OINTMENT [SKINFIX, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20241228_f28c251e-a91b-4ed4-8224-b47c345f982f.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 57 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61328-120-11 61328012011 50 g in 1 TUBE (61328-120-11) 50 g 2018-12-26 0000-00-00 No No Current 61328-120-12 61328012012 8.5 g in 1 TUBE (61328-120-12) 8.5 g 2018-12-26 0000-00-00 No No Current 61328-120-13 61328012013 102 g in 1 TUBE (61328-120-13) 102 g 2019-05-17 0000-00-00 No No Current