Home NDC 55681-304 PROCURE
Product NDC 55681-304
11-digit product format 556810304
Labeler code 55681
Product ID 55681-304_58273b5e-0985-f14a-e063-6294a90ad1f4
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form OINTMENT
Route TOPICAL
Labeler TWIN MED, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-05-23
Marketing end 2028-03-31
Substance ZINC OXIDE
Active strength 20 g/100g
NDC exclude flag No
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 PROCURE Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 20 g/100g
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 198911 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 55681-304-03 PROCURE 28.3 g in 1 TUBE OINTMENT 28.3 3 55681-304-04 PROCURE 56.6 g in 1 TUBE OINTMENT 56.6 3 55681-304-05 PROCURE 425 g in 1 JAR OINTMENT 425 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55681-304 PROCURE (ZINC OXIDE) OINTMENT [TWIN MED, LLC] 2 Current NDC, Legacy NDC, 3 package rows 20240109_e68ae97e-668e-31c2-e053-2995a90ab4d3.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 39 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 Marketing end Sample Exclude flag Status 55681-304-03 55681030403 28.3 g in 1 TUBE (55681-304-03) 28.3 g 2013-05-23 2028-02-28 No No Current 55681-304-04 55681030404 56.6 g in 1 TUBE (55681-304-04) 56.6 g 2013-05-23 2028-02-28 No No Current 55681-304-05 55681030405 425 g in 1 JAR (55681-304-05) 425 g 2013-05-23 2028-03-31 No No Current