Home NDC 55681-034-04 ProCure HydroShield
Product NDC 55681-034
Requested package NDC 55681-034-04
11-digit product format 556810034
Labeler code 55681
Product ID 55681-034_5828d726-ec07-e486-e063-6294a90a0ba1
Type HUMAN OTC DRUG
Nonproprietary name Petrolatum 44.28%
Dosage form OINTMENT
Route TOPICAL
Labeler Twin Med LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-09-15
Marketing end 2029-03-31
Substance PETROLATUM
Active strength 44.28 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 HydroShield Active Ingredients# Ingredient, Strength table Ingredient Strength PETROLATUM 44.28 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4T6H12BN9U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2609764 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 55681-034-04 ProCure HydroShield 106 g in 1 TUBE OINTMENT 106 2 55681-034-16 ProCure HydroShield 453 g in 1 JAR OINTMENT 453 2
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 52 of 68 · 1,350 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 55681-034-04 55681003404 106 g in 1 TUBE (55681-034-04) 106 g 2025-09-15 2027-11-27 No No Historical