Home NDC 11527-058 Dr. Sheffield Diaper Rash
Product NDC 11527-058
11-digit product format 115270058
Labeler code 11527
Product ID 11527-058_569610c1-6c56-4437-a651-2004d621d8ac
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form OINTMENT
Route TOPICAL
Labeler Sheffield Pharmaceuticals LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2002-01-09
Substance ZINC OXIDE
Active strength 400 mg/g
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 Dr. Sheffield Diaper Rash
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 400 mg/g
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 244638 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 11527-058-40 Dr. Sheffield Diaper Rash 28 g in 1 TUBE OINTMENT 28 4 11527-058-40 Dr. Sheffield Diaper Rash 1 in 1 CARTON OINTMENT 1 4 11527-058-41 Dr. Sheffield Diaper Rash 56 g in 1 TUBE OINTMENT 56 4 11527-058-41 Dr. Sheffield Diaper Rash 1 in 1 CARTON OINTMENT 1 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC] 1 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC] 1 COD LIVER OIL INACTIVE INGREDIENT BBL281NWFG DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC] 1 LANOLIN INACTIVE INGREDIENT 7EV65EAW6H DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11527-058 DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS LLC] 4 Current NDC, Legacy NDC, 4 package rows 20231129_cac77320-b5cf-4edf-9693-ebabfb61390c.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 29 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TrueLipids Relieve and Protect CL MD WHITE PETROLATUM Claridei Laboratories, Inc. 27c0af9b-f397-dec3-e063-6394a90aed8b 2025-12-15 Warnings Exact identifier application number: M016 Truelipids TrueLips Lip Balm CL MD WHITE PETROLATUM Claridei Laboratories, Inc. 27c155dc-f194-6750-e063-6394a90a20b1 2025-12-15 Warnings Exact identifier application number: M016 Aquaphor Healing PETROLATUM Beiersdorf Inc 0a17bf6f-6114-4647-a509-65999255c37b 2025-12-15 Warnings Exact identifier application number: M016 Aquaphor Original PETROLATUM Beiersdorf Inc d38ec874-7b8c-4b9b-92b6-286278bb67f3 2025-12-15 Warnings Exact identifier application number: M016 Aquaphor Healing Diaper Rash ZINC OXIDE Beiersdorf Inc dec07dfc-67a2-46ad-8fab-828488bdba15 2025-12-15 Warnings Exact identifier application number: M016 HealthWise Diabetic Foot Cream DIMETHICONE, PETROLATUM Veridian Healthcare 7ba0ac53-c78c-4a70-a977-a082f731919e 2025-12-15 Warnings Exact identifier application number: M016 Aquaphor Lip Protectant and Sunscreen PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE Beiersdorf Inc a43c2802-9cf1-477e-9f93-e11cf40b480d 2025-12-15 Warnings Exact identifier application number: M016 Prequel Barrier Therapy Rich Skin Protectant Cream SKIN PROTECTANT CREAM The Center Brands, LLC 39945806-8f29-020b-e063-6294a90a9fc6 2025-12-13 Warnings Exact identifier application number: M016 ECZEMA COLLOIDAL OATMEAL Smith Amish, LLC 20c4bc16-ba20-47ec-e063-6394a90a8b4e 2025-12-12 Warnings Exact identifier application number: M016 Humco Calagesic CALAMINE AND PRAMOXINE HYDROCHLORIDE Humco Holding Group, Inc. 8c43590d-56ec-4588-8076-99ba94a16685 2025-12-11 Warnings Exact identifier application number: M016 Soteri Skin Baby Eczema Relief Cream COLLOIDAL OATMEAL Soteri Skin, Inc 41d88ff2-22aa-8447-e063-6294a90aea0e 2025-12-10 Warnings Exact identifier application number: M016 Soteri Skin Active Flare-Up Eczema Relief Cream COLLOIDAL OATMEAL Soteri Skin, Inc. 41b558d9-55ba-97ff-e063-6394a90a963b 2025-12-10 Warnings Exact identifier application number: M016 CeraVe Developed With Dermatologist Baby Eczema Relief Cream OATMEAL L'Oreal USA Products Inc 5d392529-9f0c-40bc-92ca-7003f8e64b1c 2025-12-09 Warnings Exact identifier application number: M016 CeraVe Developed with Dermatologists Eczema Relief Moisturizing COLLOIDAL OATMEAL L'Oreal USA Products Inc c4dde987-fe4e-4f8e-8f3a-1bc12c9588ed 2025-12-09 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 446ddb19-4bdb-6827-e063-6394a90a6af8 2025-12-09 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Warm Vanilla COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 45864832-51bb-4e24-e063-6294a90ab554 2025-12-09 Warnings Exact identifier application number: M016 AquaSoothe AQUASOOTHE Dynarex Corporation 45878c3c-d05d-984c-e063-6294a90a4661 2025-12-09 Warnings Exact identifier application number: M016 Soteri Skin Long-Term Eczema Relief Cream COLLOIDAL OATMEAL Soteri Skin, Inc 41d752cb-3866-e840-e063-6394a90acc37 2025-12-09 Warnings Exact identifier application number: M016 Earths Care Eczema OATMEAL DLC Laboratories, Inc. f72e2adf-8930-458f-a6cc-9b240b2f5eba 2025-12-08 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Sparkling Grapefruit COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 4575ba40-009c-26e0-e063-6394a90adee6 2025-12-08 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 11527-058-40 11527005840 1 TUBE in 1 CARTON (11527-058-40) / 28 g in 1 TUBE 1 tube 2014-01-17 0000-00-00 No No Current 11527-058-41 11527005841 1 TUBE in 1 CARTON (11527-058-41) / 56 g in 1 TUBE 1 tube 2002-01-09 0000-00-00 No No Current