Home NDC 82876-989 Earthmed Lip Balm unflavored
Product NDC 82876-989
11-digit product format 828760989
Labeler code 82876
Product ID 82876-989_3ba1f64c-5672-53c6-e063-6294a90adda4
Type HUMAN OTC DRUG
Nonproprietary name Allantoin
Dosage form SALVE
Route TOPICAL
Labeler Earthmed LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-05
Substance ALLANTOIN
Active strength .045 g/4.455g
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 Earthmed Lip Balm unflavored
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALLANTOIN .045 g/4.455g
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82876-989-01 Earthmed Lip Balm unflavored 4.455 g in 1 TUBE SALVE 4.455 2
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 39 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 82876-989-01 82876098901 4.455 g in 1 TUBE (82876-989-01) 4.455 g 2025-08-05 No No Current