Home NDC 76162-496 Dimethicone
Product NDC 76162-496
11-digit product format 761620496
Labeler code 76162
Product ID 76162-496_4ab96f1f-2e42-3a02-e063-6394a90a7001
Type HUMAN OTC DRUG
Nonproprietary name Dimethicone
Dosage form LOTION
Route TOPICAL
Labeler Topco Associates LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-18
Substance DIMETHICONE
Active strength 12 mg/mL
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Dimethicone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 12 mg/mL
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 876980 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 76162-496-44 Dimethicone 532 mL in 1 BOTTLE, PLASTIC LOTION 532 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76162-496 DIMETHICONE LOTION [TOPCO ASSOCIATES LLC] 2 Current NDC, 1 package rows 20250406_f37f17f7-f084-4b74-8361-178d2315a476.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 45 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 Sample Exclude flag Status 76162-496-44 76162049644 532 mL in 1 BOTTLE, PLASTIC (76162-496-44) 532 ml 2024-04-18 No No Current