Home NDC 75376-104 Awaken Moisturizing Cream
Product NDC 75376-104
11-digit product format 753760104
Labeler code 75376
Product ID 75376-104_3ce09ce0-f4bd-96bf-e063-6394a90aae07
Type HUMAN OTC DRUG
Nonproprietary name dimethicone
Dosage form CREAM
Route TOPICAL
Labeler Guangzhou Danting Bath&Body Care Industry Co. Ltd
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-21
Substance DIMETHICONE
Active strength 5 g/100g
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 Awaken Moisturizing Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 5 g/100g
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 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 75376-104-16 Awaken Moisturizing Cream 453 g in 1 BOTTLE CREAM 453 1
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 30 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 75376-104-16 75376010416 453 g in 1 BOTTLE (75376-104-16) 453 g 2025-08-21 No No Current