Home NDC 0299-4103 Cetaphil Baby Soothe and Protect Cream
Product NDC 0299-4103
11-digit product format 002994103
Labeler code 0299
Product ID 0299-4103_01b1ef2f-f664-450b-9fc1-81c61d1ed6b1
Type HUMAN OTC DRUG
Nonproprietary name allantoin
Dosage form CREAM
Route TOPICAL
Labeler Galderma Laboratories, L.P.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-02-03
Substance ALLANTOIN
Active strength 5 mg/g
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 Cetaphil Baby Soothe and Protect Cream
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 241509 Internal RxNorm 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 0299-4103-05 Cetaphil Baby Soothe and Protect Cream 170 g in 1 TUBE CREAM 170 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0299-4103 CETAPHIL BABY SOOTHE AND PROTECT CREAM (ALLANTOIN) CREAM [GALDERMA LABORATORIES, L.P.] 4 Current NDC, Legacy NDC, 1 package rows 20231128_38254e03-3716-4e45-86b7-06430ebadc86.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 66 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 0299-4103-05 00299410305 170 g in 1 TUBE (0299-4103-05) 170 g 2020-02-03 0000-00-00 No No Current