Home NDC 55681-025 ProCure Moisture Barrier
Product NDC 55681-025
11-digit product format 556810025
Labeler code 55681
Product ID 55681-025_39eea0b7-df3d-a70e-e063-6294a90a19ea
Type HUMAN OTC DRUG
Nonproprietary name 1% Dimethicone, 12% ZInc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Twin Med LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-09
Substance ZINC OXIDE; DIMETHICONE
Active strength 12; 1 g/100g; g/100g
Pharmacologic classes Skin Barrier Activity [PE]
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 ProCure Moisture Barrier
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 12 g/100g DIMETHICONE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 92RU3N3Y1O Internal UNII 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 55681-025-04 ProCure Moisture Barrier 113 g in 1 TUBE CREAM 113 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 45 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55681-025-04 55681002504 113 g in 1 TUBE (55681-025-04) 113 g 2025-07-09 No No Current