Home NDC 53329-163 Medline
Product NDC 53329-163
11-digit product format 533290163
Labeler code 53329
Product ID 53329-163_101b9933-c2b9-0fdd-e063-6294a90a306a
Type HUMAN OTC DRUG
Nonproprietary name white petrolatum, zinc oxide
Dosage form OINTMENT
Route TOPICAL
Labeler Medline Industries, LP
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-01
Substance WHITE PETROLATUM; ZINC OXIDE
Active strength 71.5; 1 g/100g; g/100g
NDC exclude flag No
Listing certified through 2026-12-31
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength WHITE PETROLATUM 71.5 g/100g ZINC OXIDE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B6E5W8RQJ4 Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2587748 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53329-163-10 Medline 71 g in 1 TUBE OINTMENT 71 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-163 MEDLINE (WHITE PETROLATUM, ZINC OXIDE) OINTMENT [MEDLINE INDUSTRIES, LP] 1 Current NDC, 1 package rows 20240130_101b9933-c2b8-0fdd-e063-6294a90a306a.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 28 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 53329-163-10 53329016310 71 g in 1 TUBE (53329-163-10) 71 g 2024-01-01 No No Current