Home NDC 69366-505-28 Calm and Heal Melting Balm
Product NDC 69366-505
Requested package NDC 69366-505-28
11-digit product format 693660505
Labeler code 69366
Product ID 69366-505_eea2ae69-c25a-a9e0-e053-2a95a90a144b
Type HUMAN OTC DRUG
Nonproprietary name Allantoin
Dosage form CREAM
Route TOPICAL
Labeler The Honest Company, Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-09-29
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 Calm and Heal Melting Balm
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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69366-505-23 Calm and Heal Melting Balm 1 in 1 CARTON CREAM 1 4 69366-505-23 Calm and Heal Melting Balm 50 g in 1 JAR CREAM 50 4 69366-505-28 Calm and Heal Melting Balm 1 in 1 CARTON CREAM 1 4 69366-505-28 Calm and Heal Melting Balm 15 g in 1 JAR CREAM 15 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69366-505 CALM AND HEAL MELTING BALM (ALLANTOIN) CREAM [THE HONEST COMPANY, INC.] 4 Current NDC, Legacy NDC, 4 package rows 20231220_b08a1bd6-986d-9520-e053-2995a90a865e.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 44 of 68 · 1,350 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69366-505-28 69366050528 1 JAR in 1 CARTON (69366-505-28) / 15 g in 1 JAR 1 jar 2021-09-01 0000-00-00 Yes No Current