Home NDC 53329-768 Medline
Product NDC 53329-768
11-digit product format 533290768
Labeler code 53329
Product ID 53329-768_41349255-e0cd-8d71-e063-6394a90a32ca
Type HUMAN OTC DRUG
Nonproprietary name zinc oxide
Dosage form SPRAY
Route TOPICAL
Labeler Medline Industries, LP
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-01
Substance ZINC OXIDE
Active strength 250 mg/mL
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 ZINC OXIDE 250 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 865073 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 53329-768-55 Medline 59 mL in 1 BOTTLE, SPRAY SPRAY 59 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-768 MEDLINE (ZINC OXIDE) SPRAY [MEDLINE INDUSTRIES, LP] 2 Current NDC, 1 package rows 20241027_dae45414-7401-9536-e053-2a95a90a0a86.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 53329-768-55 53329076855 59 mL in 1 BOTTLE, SPRAY (53329-768-55) 59 ml 2023-12-01 No No Current