Home NDC 53329-159 Medline
Product NDC 53329-159
11-digit product format 533290159
Labeler code 53329
Product ID 53329-159_5c3e33fc-648e-a2a3-e063-6294a90a4845
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 2023-04-01
Substance DIMETHICONE
Active strength 125 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 125 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-159 MEDLINE (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, LP] 3 Current NDC, 5 package rows 20240514_ddab5235-1188-3866-e053-2a95a90a7a31.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 57 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 53329-159-04 53329015904 118 mL in 1 TUBE (53329-159-04) 118 ml 2023-04-01 No No Current 53329-159-13 53329015913 59 mL in 1 TUBE (53329-159-13) 59 ml 2023-05-01 No No Current 53329-159-77 53329015977 4 mL in 1 PACKET (53329-159-77) 4 ml 2024-05-01 No No Current 53329-159-96 53329015996 144 PACKET in 1 BOX (53329-159-96) / 4 mL in 1 PACKET 144 packet 2024-05-01 No No Current