FDA.reportPublic FDA data

Dr. Sheffield Anti Itch Cream

Product NDC
11527-069
11-digit product format
115270069
Labeler code
11527
Product ID
11527-069_36f56c5a-15fe-4243-83a4-e9a54eca9a13
Type
HUMAN OTC DRUG
Nonproprietary name
Anti Itch Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Sheffield Pharmaceuticals LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-11-11
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
20; 1 mg/g; mg/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage11527-069-04IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage11527-069-04IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage11527-069-04EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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 Anti Itch Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE20 mg/g
ZINC ACETATE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup
FM5526K07AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1087026Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
77f0593e-f694-4c02-9fd9-ad56ff2a920cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11527-069-042021-11-24C16284748780-19d75b9d0-585d-f424-e053-dadaa90a57ceSheffield Extra Strength Anti- Itch Cream
11527-069-042020-01-31C16284748780-19d75b9d0-585d-f424-e053-dadaa90a57ceSheffield Extra Strength Anti- Itch Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-069-04Dr. Sheffield Anti Itch Cream35 g in 1 TUBECREAM353
11527-069-04Dr. Sheffield Anti Itch Cream1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-069-04GM - Gram11527-06943a1f25b-33f7-4fd3-b5cf-f4abb6578be412021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
ZINC ACETATEACTIVE INGREDIENTFM5526K07ADR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
ZINC CATIONACTIVE MOIETY13S1S8SF37DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNDR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
PEG-20 STEARATEINACTIVE INGREDIENTNBX892EA57DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RDR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-069DR. SHEFFIELD ANTI ITCH CREAM (ANTI ITCH CREAM) CREAM [SHEFFIELD PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 2 package rows20231031_77f0593e-f694-4c02-9fd9-ad56ff2a920c.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 12 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Herpecin Pain ReliefALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCLFocus Consumer Healthcare, LLCbeeb6043-6547-4fe9-e053-2995a90a5d742026-04-30WarningsExact identifier
application number: M016
CVSPETROLATUMApollo Health and Beauty Care47d2b9be-91ad-e9e2-e063-6294a90ac29f2026-04-30WarningsExact identifier
application number: M016
Dr. NumbLIDOCAINEShinpharma Inc0578fbcb-875a-4606-acde-dcecb29756e62026-04-30WarningsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALAmazon.com Services LLC423c821d-92af-47f0-b9ee-8b68ecbcc44e2026-04-29Warnings, Adverse reactionsExact identifier
application number: M016
MICRO INFUSIONSYSTEMSEEK GLONingbo Kenwei International Trade Co., Ltd.50746cab-bfcc-fe0b-e063-6394a90adc012026-04-27WarningsExact identifier
application number: M016
Pharmacy ChoiceMENTHOL, ZINC OXIDEPHARMACY CHOICE INC5031fc05-e1c7-40b1-e063-6394a90aa12c2026-04-24WarningsExact identifier
application number: M016
Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTIONSEL PH BABY PH-BALANCED ECZEMA DRYNESS BABYGuangzhou Ariel Biotech Co., Ltd.5040b707-87af-3859-e063-6294a90afb3d2026-04-24WarningsExact identifier
application number: M016
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
application number: M016
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
application number: M016
Arm and Hammer Baking SodaSODIUM BICARBONATEChurch & Dwight Co., Inc.643fe204-4a7b-00e4-e053-2a91aa0aef062026-04-21WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMMY IMPORTS USA LLC4fba8bc7-590d-f621-e063-6294a90ad8c92026-04-18WarningsExact identifier
application number: M016
Anti-Itch Regular StrengthHYDROCORTISONECVS Pharmacy9fe7768b-9023-c9ee-e053-2a95a90a55b32026-04-17WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONPharma Nobis, LLC4f853183-5925-2c73-e063-6394a90adf6c2026-04-15WarningsExact identifier
application number: M016
Freskaro Calamine PlusZINC OXIDE LOTIONPharma Nobis, LLC4f85bdc7-8fed-f1f5-e063-6394a90a63582026-04-15WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDynarex Corporation11d79dd6-35f7-4399-e063-6294a90ac7dd2026-04-13WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f261746-37e9-7b30-e063-6294a90a92242026-04-10WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f268501-6cd7-7edd-e063-6294a90ac6492026-04-10WarningsExact identifier
application number: M016
BEVERLY HILLS MD HYDRARESCUE TREATMENTDIMETHICONEBeverly Hills MD, LLC4ed33a43-d059-2589-e063-6294a90a30b32026-04-09WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWAL-MART STORES INC00faa772-53f3-9276-e063-6394a90a2dab2026-04-07WarningsExact identifier
application number: M016
ProCure Zinc OxideZINC OXIDETwin Med LLC37a30ee5-fd33-b410-e063-6294a90aef722026-04-07WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN77f0593e-f694-4c02-9fd9-ad56ff2a920c3
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD77f0593e-f694-4c02-9fd9-ad56ff2a920c3
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY77f0593e-f694-4c02-9fd9-ad56ff2a920c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11527-069-04115270069041 TUBE in 1 CARTON (11527-069-04) / 35 g in 1 TUBE1 tube2008-11-110000-00-00NoNoCurrent