dimethicone

Generic: dimethicone

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dimethicone
Generic Name dimethicone
Labeler topco associates llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

dimethicone 12 mg/mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-496
Product ID 76162-496_4ab96f1f-2e42-3a02-e063-6394a90a7001
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2027-12-31
Marketing Start 2024-04-18

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162496
Hyphenated Format 76162-496

Supplemental Identifiers

RxCUI
876980
UNII
92RU3N3Y1O
NUI
N0000010282

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dimethicone (source: ndc)
Generic Name dimethicone (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 12 mg/mL
source: ndc
Packaging
  • 532 mL in 1 BOTTLE, PLASTIC (76162-496-44)
source: ndc

Packages (1)

76162-496-44 532 mL in 1 BOTTLE, PLASTIC (76162-496-44)

Ingredients (1)

dimethicone (12 mg/mL)

Linked Drug Pages (1)

Dimethicone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4ab96f1f-2e42-3a02-e063-6394a90a7001", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O"], "rxcui": ["876980"], "spl_set_id": ["f37f17f7-f084-4b74-8361-178d2315a476"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "532 mL in 1 BOTTLE, PLASTIC (76162-496-44)", "package_ndc": "76162-496-44", "marketing_start_date": "20240418"}], "brand_name": "Dimethicone", "product_id": "76162-496_4ab96f1f-2e42-3a02-e063-6394a90a7001", "dosage_form": "LOTION", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "76162-496", "generic_name": "Dimethicone", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dimethicone", "active_ingredients": [{"name": "DIMETHICONE", "strength": "12 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240418", "listing_expiration_date": "20271231"}