Home NDC 55681-034 ProCure HydroShield
Product NDC 55681-034
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 65 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HEB Calagesic ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE H E B 5d579680-6bcb-1161-e053-2991aa0aead1 2023-12-18 Warnings Exact identifier application number: M016 Publix Clear Anti-Itch ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE Publix 5d6b905f-ed30-1ab7-e053-2a91aa0a816b 2023-12-18 Warnings Exact identifier application number: M016 Humco Calaclear PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE Humco Holding Group, Inc. 5fca3a73-6d66-496b-bd33-6e044f9039bc 2023-12-15 Warnings Exact identifier application number: M016 Calamine Phenolated Topical Suspension CALAMINE AND ZINC OXIDE AND PHENOL Humco Holding Group, Inc a3816729-be2b-4b4f-a609-953576cd2e3b 2023-12-15 Warnings Exact identifier application number: M016 Humco Mineral Oil Light MINERAL OIL Humco Holding Group, Inc. 753f35c3-1420-4817-ba63-b737a9c99a1d 2023-12-15 Warnings Exact identifier application number: M016 Humco Witch Hazel WITCH HAZEL Humco Holding Group, Inc. 3cf07016-a129-49ca-8fad-b67dda5aa009 2023-12-15 Warnings Exact identifier application number: M016 Rite Aid Calamine CALAMINE 8% AND ZINC OXIDE 8% Rite Aid Corporation 5df71189-9b36-9dee-e053-2a91aa0a9e49 2023-12-15 Warnings Exact identifier application number: M016 GNP Witch Hazel WITCH HAZEL Amerisource Bergen 45ac839d-215d-4c5f-8ae5-5e111d170061 2023-12-14 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant GLYCERIN L'Oreal USA Products Inc 32eaaaab-41bd-4efe-a71d-92e3a702c1e5 2023-12-11 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Lipikar Eczema Relief OATMEAL COSMETIQUE ACTIVE PRODUCTION e555de17-9b42-4125-a17b-467bc1d179d7 2023-12-11 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief OATMEAL L'Oreal USA Products Inc f7b71606-0044-4729-82e8-4514331806a0 2023-12-11 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 GLYCERIN Cosmetique Active Production 01c8a0d5-bcd1-4639-be45-530a226401f0 2023-12-11 Warnings Exact identifier application number: M016 Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15 CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 0bc6812a-5c2a-7bb9-e063-6294a90a36e3 2023-12-05 Warnings Exact identifier application number: M016 Carmex Classic Lip Balm Medicated Free Strawberry Stick Sunscreen SPF 15 CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 34fae56e-367d-4659-af2d-1c9ddaf1639c 2023-12-05 Warnings Exact identifier application number: M016 Diaper Rash Cream 2.5oz ZINC OXIDE Rejoice International Corp. 0ba98cdf-489e-dc2a-e063-6294a90adb38 2023-12-04 Warnings Exact identifier application number: M016 Diaper Rash Cream 2.5oz ZINC OXIDE China Ningbo Shangge Cosmetics Technology Corp. 0baa8a14-8655-d77c-e063-6294a90ab8aa 2023-12-04 Warnings Exact identifier application number: M016 THERAPLEX Eczema Therapy OATMEAL THERAPLEX, LLC 86472a3d-7138-4141-8422-ab20c17a46e0 2023-12-04 Warnings Exact identifier application number: M016 SOOTHE Moisturizing Rescue Cream OATMEAL Rodan & Fields 91163267-c2aa-47b3-b290-d1605536d806 2023-12-04 Warnings Exact identifier application number: M016 Manzatin-E Diaper Rash Skin Protectant ZINC OXIDE Laboratorios Zepol S.A. cafd084f-8493-4d6e-b256-2d4b4282f866 2023-12-01 Warnings Exact identifier application number: M016 Manzatin Diaper Rash Skin Protectant ZINC OXIDE Laboratorios Zepol S.A. 5c1618a4-ca08-4814-a556-74e79db618b9 2023-12-01 Warnings Exact identifier application number: M016
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 55681-034-16 55681003416 453 g in 1 JAR (55681-034-16) 453 g 2025-09-15 2029-03-31 No No Historical