Home NDC 81995-050 Manuka Honey Extra Strength
Product NDC 81995-050
11-digit product format 819950050
Labeler code 81995
Product ID 81995-050_2d5e1f54-b018-fce5-e063-6394a90a76d7
Type HUMAN OTC DRUG
Nonproprietary name ALLANTOIN
Dosage form GEL
Route TOPICAL
Labeler First Honey LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-01
Substance ALLANTOIN
Active strength 5 mg/g
NDC exclude flag No
Listing certified through 2027-12-31
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 Manuka Honey Extra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALLANTOIN 5 mg/g
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 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 81995-050-01 Manuka Honey Extra Strength 1 in 1 CARTON GEL 1 3 81995-050-01 Manuka Honey Extra Strength 21 g in 1 TUBE GEL 21 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81995-050 MANUKA HONEY EXTRA STRENGTH (ALLANTOIN) GEL [FIRST HONEY LLC] 3 Current NDC, 2 package rows 20250206_b742585d-9a0c-489b-b268-590583cfabd1.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81995-050-01 81995005001 1 TUBE in 1 CARTON (81995-050-01) / 21 g in 1 TUBE 1 tube 2024-09-01 No No Current