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 125 mg/mL

Manufacturer
Medline Industries, LP

Identifiers & Regulatory

Product NDC 53329-159
Product ID 53329-159_18582056-72e0-f103-e063-6394a90a1de2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2023-04-01

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53329159
Hyphenated Format 53329-159

Supplemental Identifiers

RxCUI
2613881
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
  • 125 mg/mL
source: ndc
Packaging
  • 118 mL in 1 TUBE (53329-159-04)
  • 59 mL in 1 TUBE (53329-159-13)
  • 4 mL in 1 PACKET (53329-159-77)
  • 144 PACKET in 1 BOX (53329-159-96) / 4 mL in 1 PACKET
source: ndc

Packages (4)

53329-159-04 118 mL in 1 TUBE (53329-159-04) 53329-159-13 59 mL in 1 TUBE (53329-159-13) 53329-159-77 4 mL in 1 PACKET (53329-159-77) 53329-159-96 144 PACKET in 1 BOX (53329-159-96) / 4 mL in 1 PACKET

Ingredients (1)

dimethicone (125 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": "18582056-72e0-f103-e063-6394a90a1de2", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O"], "rxcui": ["2613881"], "spl_set_id": ["ddab5235-1188-3866-e053-2a95a90a7a31"], "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 (53329-159-04)", "package_ndc": "53329-159-04", "marketing_start_date": "20230401"}, {"sample": false, "description": "59 mL in 1 TUBE (53329-159-13)", "package_ndc": "53329-159-13", "marketing_start_date": "20230501"}, {"sample": false, "description": "4 mL in 1 PACKET (53329-159-77)", "package_ndc": "53329-159-77", "marketing_start_date": "20240501"}, {"sample": false, "description": "144 PACKET in 1 BOX (53329-159-96)  / 4 mL in 1 PACKET", "package_ndc": "53329-159-96", "marketing_start_date": "20240501"}], "brand_name": "Medline", "product_id": "53329-159_18582056-72e0-f103-e063-6394a90a1de2", "dosage_form": "CREAM", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "53329-159", "generic_name": "dimethicone", "labeler_name": "Medline Industries, LP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Medline", "active_ingredients": [{"name": "DIMETHICONE", "strength": "125 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230401", "listing_expiration_date": "20261231"}