FDA.reportPublic FDA data

WinCo Original Strength Anti-Itch

Product NDC
67091-277
11-digit product format
670910277
Labeler code
67091
Product ID
67091-277_41ec24f4-f2b5-f40a-e063-6394a90ab1b4
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride, and Zinc acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
WinCo Foods, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-09
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
10; 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

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
WinCo Original Strength Anti-Itch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE10 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
1292313Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae74e163-ba1a-4d1e-aaeb-9976bd202674Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-277-28WinCo Original Strength Anti-Itch28 g in 1 TUBECREAM287
67091-277-28WinCo Original Strength Anti-Itch1 in 1 CARTONCREAM17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40WINCO ORIGINAL STRENGTH ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATE) CREAM [WINCO FOODS, LLC]1
ZINC ACETATEACTIVE INGREDIENTFM5526K07AWINCO ORIGINAL STRENGTH ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATE) CREAM [WINCO FOODS, LLC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MWINCO ORIGINAL STRENGTH ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATE) CREAM [WINCO FOODS, LLC]1
ZINC CATIONACTIVE MOIETY13S1S8SF37WINCO ORIGINAL STRENGTH ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATE) CREAM [WINCO FOODS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TWINCO ORIGINAL STRENGTH ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATE) CREAM [WINCO FOODS, LLC]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IWINCO ORIGINAL STRENGTH ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATE) CREAM [WINCO FOODS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3WINCO ORIGINAL STRENGTH ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATE) CREAM [WINCO FOODS, LLC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YWINCO ORIGINAL STRENGTH ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATE) CREAM [WINCO FOODS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RWINCO ORIGINAL STRENGTH ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATE) CREAM [WINCO FOODS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-277WINCO ORIGINAL STRENGTH ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATE) CREAM [WINCO FOODS, LLC]6Current NDC, Legacy NDC, 2 package rows20241222_ae74e163-ba1a-4d1e-aaeb-9976bd202674.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 1 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Eczema Soothing Moisturizing CreamCOLLOIDAL OATMEALNice-Pak Products, LLC23548524-2e2e-4d1a-9ebb-6f86d6279e932026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Drs. pharmacy Scar CreamALLANTOINOL PHARMA TECH, LLC Drs PHARMACYd0381034-8cf7-5e8d-e053-2995a90a9faa2026-09-09WarningsExact identifier
application number: M016
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
application number: M016
Wart RemoverGLYCERINShantou Ouhoe Technology Co., Ltd.5af3afe1-dad5-91b7-e063-6294a90ab95e2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
application number: M016
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a9aaca8-474a-0393-e063-6394a90a5a3a2026-09-04WarningsExact identifier
application number: M016
Aveeno Eczema Therapy CreamCOLLOIDAL OATMEALKenvue Brands LLC5a7b0470-3ed5-5b92-e063-6294a90ae0f42026-09-03WarningsExact identifier
application number: M016
First Aid Beauty Face and Body Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a974dbf-84ac-5374-e063-6294a90a8da02026-09-03WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMJell Pharmaceuticals Pvt. Ltd.cdc297cb-476a-6da9-e053-2a95a90a399a2026-09-02WarningsExact identifier
application number: M016
Nail Treatment LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.5a7cd607-a50e-17d0-e063-6294a90acdb22026-09-02WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1292313diphenhydrAMINE HCl 1 % / zinc acetate 0.1 % Topical CreamPSNae74e163-ba1a-4d1e-aaeb-9976bd2026747
1292313diphenhydramine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical CreamSCDae74e163-ba1a-4d1e-aaeb-9976bd2026747
1292313diphenhydramine hydrochloride 1 % / zinc acetate 0.1 % Topical CreamSYae74e163-ba1a-4d1e-aaeb-9976bd2026747

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-277-28670910277281 TUBE in 1 CARTON (67091-277-28) / 28 g in 1 TUBE1 tube2015-02-090000-00-00NoNoCurrent