Home NDC 0299-4115 Cetaphil Cracked Skin Repair Balm
Product NDC 0299-4115
11-digit product format 002994115
Labeler code 0299
Product ID 0299-4115_40277fde-372e-4ded-b7f8-15168d11582a
Type HUMAN OTC DRUG
Nonproprietary name Dimethicone
Dosage form CREAM
Route TOPICAL
Labeler Galderma Laboratories, L.P.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-05-01
Substance DIMETHICONE
Active strength 10 mg/g
Pharmacologic classes Skin Barrier Activity [PE]
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 Cracked Skin Repair Balm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200010 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 0299-4115-00 Cetaphil Cracked Skin Repair Balm 1 in 1 CARTON CREAM 1 3 0299-4115-00 Cetaphil Cracked Skin Repair Balm 85 g in 1 TUBE CREAM 85 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0299-4115 CETAPHIL CRACKED SKIN REPAIR BALM (DIMETHICONE) CREAM [GALDERMA LABORATORIES, L.P.] 3 Current NDC, Legacy NDC, 2 package rows 20231205_5efb3ef0-6ee9-4ef8-b81e-90bd1825c956.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 39 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 0299-4115-00 00299411500 1 TUBE in 1 CARTON (0299-4115-00) / 85 g in 1 TUBE 1 tube 2021-05-01 0000-00-00 No No Current