Home NDC 53329-259 Medline
Product NDC 53329-259
11-digit product format 533290259
Labeler code 53329
Product ID 53329-259_50a03f0b-b618-c7ec-e063-6294a90a48e3
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 2026-06-08
Substance DIMETHICONE
Active strength 66 mg/g
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 66 mg/g
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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 39 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53329-259-14 53329025914 57 g in 1 TUBE (53329-259-14) 57 g 2026-06-08 No No Current 53329-259-64 53329025964 142 g in 1 TUBE (53329-259-64) 142 g 2026-06-08 No No Current 53329-259-74 53329025974 256 g in 1 TUBE (53329-259-74) 256 g 2026-06-08 No No Current