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

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 Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40, FM5526K07A
Rxcui1087026

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

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