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 62 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join XtraCare Skin Relief Oatmeal Daily Moisturizing DIMETHICONE Rejoice International 5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907 2024-02-28 Warnings Exact identifier application number: M016 XtraCare with cooling action Oatmeal Skin Relief Calmin DIMETHICONE Rejoice International 29abd476-c32d-49f0-b283-30f4ba570ab4 2024-02-28 Warnings Exact identifier application number: M016 MAX BARRIER Skin Protectant ZINC OXIDE GL HEALTH, INC. 5eec834d-d8f3-49e3-b230-f8cf88b795e6 2024-02-26 Warnings Exact identifier application number: M016 Rugby Petrolatum Hydrating Skin Protectant PETROLATUM Rugby Laboratories ad63e345-1fe8-4f9a-a32e-8dfcde31bedc 2024-02-12 Warnings Exact identifier application number: M016 A and D PETROLATUM Safetec of America, Inc. b9afda3a-9e1d-46c1-b7aa-c3143caf709e 2024-02-09 Warnings Exact identifier application number: M016 Blistex Medicated Mint Balm DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 86fc9f3c-e35f-4988-bf19-64d9c6c85ee9 2024-02-09 Warnings Exact identifier application number: M016 Blistex Medicated Berry Balm DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 827365b3-b3a5-4472-9add-f822362c4731 2024-02-09 Warnings Exact identifier application number: M016 Blistex Medicated Lip Balm DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 8b4160ed-8889-4e3a-947f-a56c3324dbbe 2024-02-09 Warnings Exact identifier application number: M016 Medline WHITE PETROLATUM, ZINC OXIDE Medline Industries, LP 101b9933-c2b8-0fdd-e063-6294a90a306a 2024-01-29 Warnings Exact identifier application number: M016 XtraCare Skin Relief Oatmeal Daily Moisturizing DIMETHICONE Rejoice International 8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc 2024-01-29 Warnings Exact identifier application number: M016 Cetaphil Baby Healing PETROLATUM Galderma Laboratories, L.P. 5140754e-5db0-470f-adfd-de02b184880b 2024-01-29 Warnings Exact identifier application number: M016 CHAPSTICK CLASSIC MEDICATED CAMPHOR, MENTHOL, PETROLATUM Haleon US Holdings LLC b4259621-ff41-46cc-a658-b57bff3c1525 2024-01-23 Warnings Exact identifier application number: M016 Zinc Oxide 20% ZINC OXIDE Trifecta Pharmaceuticals USA fcef17f1-84e7-a288-e053-6294a90a064b 2024-01-19 Warnings Exact identifier application number: M016 Hydro Gel GLYCERIN 20% Trifecta Pharmaceuticals USA LLC 02e8e5d0-7844-39fe-e063-6394a90a57e1 2024-01-19 Warnings Exact identifier application number: M016 White Petrolatum WHITE PETROLATUM Sled Distribution, LLC e73a4b7a-7b27-abfc-e053-2995a90a35c2 2024-01-15 Warnings Exact identifier application number: M016 Sunmark Caldiphen CALAMINE AND PRAMOXINE HYDROCHLORIDE Strategic Sourcing Services 4f4d4c54-64b5-4e20-bed0-c7fb470b8434 2024-01-12 Warnings Exact identifier application number: M016 EIGHT HOUR NIGHT DIMETHICONE REVLON b3b277f9-565a-636c-e053-2995a90a94d2 2024-01-12 Warnings Exact identifier application number: M016 CeraVe Developed with Dermatologists Eczema Relief Creamy OATMEAL L'Oreal USA Products Inc bcf7b985-6875-4033-a412-1bb6d3afa6d8 2024-01-01 Warnings Exact identifier application number: M016 CeraVe Developed with Dermatologists Healing PETROLATUM L'Oreal USA Products Inc. 1b3ad3e8-cbac-4a92-84e2-4f3ab4512d95 2023-12-31 Warnings Exact identifier application number: M016 CeraVe Developed with Dermatologists Baby Healing PETROLATUM L'Oreal USA Products Inc. fe665bbc-1172-4f59-acc6-8d5c179693b6 2023-12-31 Warnings Exact identifier application number: M016
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