Home NDC 57337-164-01 Diaper Rash Cream 2oz
Product NDC 57337-164
Requested package NDC 57337-164-01
11-digit product format 573370164
Labeler code 57337
Product ID 57337-164_130a066e-4f9f-ae7e-e063-6294a90a2743
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Rejoice International Corp.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-06
Substance ZINC OXIDE
Active strength 40 g/100g
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 Diaper Rash Cream 2oz
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 40 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 1305337 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 57337-164-01 Diaper Rash Cream 2oz 57 g in 1 TUBE CREAM 57 1 57337-164-01 Diaper Rash Cream 2oz 1 in 1 BOX CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-164 DIAPER RASH CREAM 2OZ (ZINC OXIDE) CREAM [REJOICE INTERNATIONAL CORP.] 1 Current NDC, 2 package rows 20240308_130a06a7-3360-afed-e063-6294a90ac19f.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 65 of 68 · 1,343 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Petrolatum Jelly PETROLATUM NEW PRIDE CORP f6634410-fa1f-7987-e053-2995a90abb06 2023-12-01 Warnings Exact identifier application number: M016 Cetaphil Cracked Skin Repair Balm DIMETHICONE Galderma Laboratories, L.P. 5efb3ef0-6ee9-4ef8-b81e-90bd1825c956 2023-11-30 Warnings Exact identifier application number: M016 Cetaphil Cracked Skin Repair DIMETHICONE Galderma Laboratories, L.P. 27d74e0f-8359-4c59-bf7f-acade7f4545c 2023-11-30 Warnings Exact identifier application number: M016 Sheffield Advanced Scar Gel ADVANCED SCAR GEL Sheffield Pharmaceuticals LLC ab78b946-81ed-442c-a167-26c26c7fe8a1 2023-11-30 Warnings Exact identifier application number: M016 Akin Diaper Rash ZINC OXIDE Southern Sales & Service, Inc. f5515517-7977-48f9-aab6-cf0d2f2a04a0 2023-11-29 Warnings Exact identifier application number: M016 Dr. Sheffield Diaper Rash ZINC OXIDE Sheffield Pharmaceuticals LLC cac77320-b5cf-4edf-9693-ebabfb61390c 2023-11-28 Warnings Exact identifier application number: M016 Sheffield Zinc Oxide ZINC OXIDE Sheffield Pharmaceuticals LLC 60b54c04-4387-4954-951d-165809947310 2023-11-28 Warnings Exact identifier application number: M016 Cetaphil Baby Soothe and Protect Cream ALLANTOIN Galderma Laboratories, L.P. 38254e03-3716-4e45-86b7-06430ebadc86 2023-11-22 Warnings Exact identifier application number: M016 Cetaphil Baby Eczema Soothing COLLOIDAL OATMEAL Galderma Laboratories, L.P. d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b 2023-11-22 Warnings Exact identifier application number: M016 EczemaHoneyBodyLotion COLLOIDAL OATMEAL Allure Labs 0a710be0-562e-8368-e063-6294a90a3b1b 2023-11-18 Warnings Exact identifier application number: M016 Zinc Oxide SKIN PROTECTANT BluePoint Laboratories d9b752e6-655a-19a6-e053-2995a90a9a37 2023-11-17 Warnings Exact identifier application number: M016 UNIVERSAL ORIGINAL PETROLEUM WHITE PETROLEUM Universal Distribution Center LLC 47b8c720-ad1e-4ac7-ba73-872e409b38bf 2023-11-17 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 Sample Exclude flag Status 57337-164-01 57337016401 1 TUBE in 1 BOX (57337-164-01) / 57 g in 1 TUBE 1 tube 2024-03-06 No No Current