medline

Generic: dimethicone

Labeler: medline industries, lp
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name medline
Generic Name dimethicone
Labeler medline industries, lp
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

dimethicone 15 mg/mL

Manufacturer
Medline Industries, LP

Identifiers & Regulatory

Product NDC 53329-154
Product ID 53329-154_423d4f62-2f8b-5a6d-e063-6294a90a47c6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2023-09-01

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53329154
Hyphenated Format 53329-154

Supplemental Identifiers

RxCUI
309917
UPC
0888277678227
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 medline (source: ndc)
Generic Name dimethicone (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/mL
source: ndc
Packaging
  • 118 mL in 1 TUBE (53329-154-04)
  • 59 mL in 1 TUBE (53329-154-13)
  • 946 mL in 1 BOTTLE, PUMP (53329-154-23)
  • 1000 mL in 1 BAG (53329-154-84)
source: ndc

Packages (4)

53329-154-04 118 mL in 1 TUBE (53329-154-04) 53329-154-13 59 mL in 1 TUBE (53329-154-13) 53329-154-23 946 mL in 1 BOTTLE, PUMP (53329-154-23) 53329-154-84 1000 mL in 1 BAG (53329-154-84)

Ingredients (1)

dimethicone (15 mg/mL)

Linked Drug Pages (1)

Medline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "423d4f62-2f8b-5a6d-e063-6294a90a47c6", "openfda": {"nui": ["N0000010282"], "upc": ["0888277678227"], "unii": ["92RU3N3Y1O"], "rxcui": ["309917"], "spl_set_id": ["0d94fd18-a120-e171-e063-6394a90ae9c0"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Medline Industries, LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 TUBE (53329-154-04)", "package_ndc": "53329-154-04", "marketing_start_date": "20231101"}, {"sample": false, "description": "59 mL in 1 TUBE (53329-154-13)", "package_ndc": "53329-154-13", "marketing_start_date": "20230901"}, {"sample": false, "description": "946 mL in 1 BOTTLE, PUMP (53329-154-23)", "package_ndc": "53329-154-23", "marketing_start_date": "20231101"}, {"sample": false, "description": "1000 mL in 1 BAG (53329-154-84)", "package_ndc": "53329-154-84", "marketing_start_date": "20231101"}], "brand_name": "Medline", "product_id": "53329-154_423d4f62-2f8b-5a6d-e063-6294a90a47c6", "dosage_form": "CREAM", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "53329-154", "generic_name": "dimethicone", "labeler_name": "Medline Industries, LP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Medline", "active_ingredients": [{"name": "DIMETHICONE", "strength": "15 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230901", "listing_expiration_date": "20261231"}