FDA.reportPublic FDA data

Shopko Anti-Itch

Product NDC
37012-089
11-digit product format
370120089
Labeler code
37012
Product ID
37012-089_39e53a54-ad67-5db4-e063-6294a90aa72e
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride and zinc acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Shopko Stores Operating Co., LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-09-20
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
Shopko Anti-Itch
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
37012-089-022024-11-15C16284748780-19d75b9cf-f78e-f424-e053-dadaa90a57ceShopko ® Anti-Itch Cream
37012-089-022020-01-31C16284748780-19d75b9cf-f78e-f424-e053-dadaa90a57ceShopko ® Anti-Itch Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37012-089-02Shopko Anti-Itch28.4 g in 1 TUBECREAM28.43
37012-089-02Shopko Anti-Itch1 in 1 CARTONCREAM13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD40SHOPKO ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
zinc acetateACTIVE INGREDIENTFM5526K07ASHOPKO ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
diphenhydramineACTIVE MOIETY8GTS82S83MSHOPKO ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
zinc cationACTIVE MOIETY13S1S8SF37SHOPKO ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNSHOPKO ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4SHOPKO ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TSHOPKO ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
PEG-100 stearateINACTIVE INGREDIENTYD01N1999RSHOPKO ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3SHOPKO ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHSHOPKO ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
waterINACTIVE INGREDIENT059QF0KO0RSHOPKO ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [SHOPKO STORES OPERATING CO., LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37012-089SHOPKO ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [SHOPKO STORES OPERATING CO., LLC]2Current NDC, Legacy NDC, 2 package rows20241116_130119eb-b87e-4a07-8d2a-317369bfa541.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN130119eb-b87e-4a07-8d2a-317369bfa5413
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD130119eb-b87e-4a07-8d2a-317369bfa5413
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY130119eb-b87e-4a07-8d2a-317369bfa5413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37012-089-02370120089021 TUBE in 1 CARTON (37012-089-02) / 28.4 g in 1 TUBE1 tube2005-09-20NoNoHistorical