FDA.reportPublic FDA data

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
IngredientStrength
ZINC OXIDE400 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
244638Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cac77320-b5cf-4edf-9693-ebabfb61390cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-058-40Dr. Sheffield Diaper Rash28 g in 1 TUBEOINTMENT284
11527-058-40Dr. Sheffield Diaper Rash1 in 1 CARTONOINTMENT14
11527-058-41Dr. Sheffield Diaper Rash56 g in 1 TUBEOINTMENT564
11527-058-41Dr. Sheffield Diaper Rash1 in 1 CARTONOINTMENT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-058-41GM - Gram11527-05801e5a460-122f-4378-81d1-b67ba2d5ddb412021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZDR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZDR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UDR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC]1
COD LIVER OILINACTIVE INGREDIENTBBL281NWFGDR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC]1
LANOLININACTIVE INGREDIENT7EV65EAW6HDR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UDR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RDR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-058DR. SHEFFIELD DIAPER RASH (ZINC OXIDE) OINTMENT [SHEFFIELD PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 4 package rows20231129_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 41 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
terrasil Infection Protection Wound CareALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionse98d1d8c-c979-49de-9bd8-cd409efff6de2025-07-11WarningsExact identifier
application number: M016
Neosporin Lip Health Overnight Renewal TherapyPETROLATUMKenvue Brands LLC0da54fe1-c99f-4a2d-9ee5-2dc24005096c2025-07-10WarningsExact identifier
application number: M016
COCOA BUTTER PETROLEUM jellyPETROLATUMSavvy Care & Cosmetics Pvt. Ltd.397d13f1-3b86-3c76-e063-6394a90a0f242025-07-09WarningsExact identifier
application number: M016
Pipette EczemaCOLLOIDAL OATMEALPipette LLC39829827-d801-f5a7-e063-6394a90a024c2025-07-09WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEWestminster Pharmaceuticals, LLC7e045b3a-f33b-4faa-ab9b-2baec6ff79242025-07-08WarningsExact identifier
application number: M016
Desitin Multi-Purpose HealingPETROLATUMKenvue Brands LLC30f06dbb-de8c-43ee-b1ed-99ffd59dd3ab2025-07-07WarningsExact identifier
application number: M016
Astringent SolutionALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATEFirst Nation Group065c895c-7d86-f1ed-e063-6394a90a3a522025-07-07WarningsExact identifier
application number: M016
Creamy PetroleumPETROLATUMSavvy Care & Cosmetics Pvt Ltd3916daee-f8d2-e3f0-e063-6294a90a38832025-07-04WarningsExact identifier
application number: M016
Exemax CreamDIMETHICONE, ALLANTOINPureTek Corporation38e79055-df84-d314-e063-6394a90ac95f2025-07-01WarningsExact identifier
application number: M016
Procure Dimethicone 5%DIMETHICONETwin Med LLC38a7e4af-997d-549e-e063-6394a90a0bd62025-06-28WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDerma Sciences Canada Inc.37eff762-1ea9-ec66-e063-6394a90a3d102025-06-19WarningsExact identifier
application number: M016
Dr.Johnes SKIN TAG REMOVERSALICYLIC ACIDDr.Johnes LLCb731c55e-31ee-429f-8432-fac7c5718d832025-06-18WarningsExact identifier
application number: M016
Dr. Johne SKIN TAG REMOVERSALICYLIC ACIDDr.Johnes LLC6c5adc3c-9d45-449a-ad42-f9571851cd182025-06-18WarningsExact identifier
application number: M016
THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal OatmealOATMEALTHERAPLEX, LLCe51aa467-ffe7-4c6b-8588-6df8592596d42025-06-16WarningsExact identifier
application number: M016
ZIIDII Wild Yam CreamWILD YAMGuangzhou Haishi Biological Technology Co., Ltd.3733154a-4884-9988-e063-6294a90aa78c2025-06-10WarningsExact identifier
application number: M016
Aveeno Calm Plus Restore Skin Therapy BalmCOLLOIDAL OATMEALKenvue Brands LLCdbe7a2cc-9c21-2a48-e053-2a95a90a54e22025-06-04WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWALGREENS2017113f-d192-5fbb-e063-6294a90a83b02025-05-31WarningsExact identifier
application number: M016
AHHH Bite ReliefSODIUM BICARBONATE7827125a1e070-9228-4ec9-e063-6294a90ad78d2025-05-27WarningsExact identifier
application number: M016
SupreH Bee Venom Skin Tag Treatment LiquidSUPREH BEE VENOM SKIN TAG REMOVER LIQUIDShenzhen Xinxin Yunhai Technology Co., Ltd.35ca9836-917a-b0ac-e063-6294a90a28a22025-05-23WarningsExact identifier
application number: M016
terrasil Diabetics Ulcer and Bed Sore ReliefALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions35d2738c-dacf-7309-e063-6294a90aab4c2025-05-23WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244638zinc oxide 40 % Topical OintmentPSNcac77320-b5cf-4edf-9693-ebabfb61390c4
244638zinc oxide 0.4 MG/MG Topical OintmentSCDcac77320-b5cf-4edf-9693-ebabfb61390c4
244638zinc oxide 40 % Topical OintmentSYcac77320-b5cf-4edf-9693-ebabfb61390c4
244638ZNO 0.4 MG/MG Topical OintmentSYcac77320-b5cf-4edf-9693-ebabfb61390c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11527-058-40115270058401 TUBE in 1 CARTON (11527-058-40) / 28 g in 1 TUBE1 tube2014-01-170000-00-00NoNoCurrent
11527-058-41115270058411 TUBE in 1 CARTON (11527-058-41) / 56 g in 1 TUBE1 tube2002-01-090000-00-00NoNoCurrent