Home NDC 53329-155 Medline
Product NDC 53329-155
11-digit product format 533290155
Labeler code 53329
Product ID 53329-155_5a096e34-45e4-2d7d-e063-6294a90aad9a
Type HUMAN OTC DRUG
Nonproprietary name dimethicone
Dosage form CREAM
Route TOPICAL
Labeler Medline Industries, LP
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-08-01
Substance DIMETHICONE
Active strength 15 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 Medline
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 15 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 309917 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53329-155-04 Medline 118 mL in 1 TUBE CREAM 118 2 53329-155-13 Medline 59 mL in 1 TUBE CREAM 59 2 53329-155-23 Medline 946 mL in 1 BOTTLE, PUMP CREAM 946 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-155 MEDLINE (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, LP] 1 Current NDC, 3 package rows 20231229_0d964138-f68d-dbf5-e063-6294a90a8320.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 59 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 53329-155-04 53329015504 118 mL in 1 TUBE (53329-155-04) 118 ml 2023-09-01 No No Current 53329-155-13 53329015513 59 mL in 1 TUBE (53329-155-13) 59 ml 2023-08-01 No No Current 53329-155-23 53329015523 946 mL in 1 BOTTLE, PUMP (53329-155-23) 946 ml 2023-09-01 No No Current 53329-155-84 53329015584 1000 mL in 1 BAG (53329-155-84) 1000 ml 2026-09-01 No No Current