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 10 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EELHOE Cuticle Pusher PenGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.52c7f956-a2a1-ae1d-e063-6294a90ab3c22026-05-27WarningsExact identifier
application number: M016
Dermoia Eczema Relief Colloidal OatmealOATMEALTreasurewise LLC1285c0a4-5fdf-4691-a8c6-1de8e2e2f66a2026-05-27WarningsExact identifier
application number: M016
CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEWal-Mart Stores, Inc.61e76e2a-fc46-7a64-e053-2991aa0a56a82026-05-26WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEWal-Mart Stores, Inc.61929c97-bd6b-0d7c-e053-2991aa0aa5712026-05-26WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
application number: M016
Humco CalamineCALAMINE 8% AND ZINC OXIDE 8%Humco holding Group, Inc.f7dcd959-fb98-43bb-8dd3-a662bf8a053c2026-05-26WarningsExact identifier
application number: M016
Advanced HealingPETROLATUMCVS Pharamacy, Inc0bd3380e-2284-44a7-b2ef-68c9909627fd2026-05-26Warnings, Adverse reactionsExact identifier
application number: M016
CeraVe Developed with Dermatologists Healing Lip BalmPETROLATUML'Oreal USA Products Inc21dc8842-0672-4d46-bcea-b8e3d54c48bf2026-05-20WarningsExact identifier
application number: M016
AFTER CAREDIMETHICONEMerz North Americac19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae2026-05-20WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USA63b551fc-7d16-c099-e053-2a91aa0a5f2c2026-05-18WarningsExact identifier
application number: M016
ADVANCED SILICONE SCARALLANTOINYantai Aien Biotechnology Co., Ltd.51ffdc45-5acf-ae20-e063-6294a90a55e82026-05-17WarningsExact identifier
application number: M016
LCFateLC Nail LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.51ea23f4-0a23-4ae1-e063-6394a90aa0512026-05-16WarningsExact identifier
application number: M016
Radlive Active Defense Nano-Silver CreamCOLLOIDAL OATMEALSilverCeuticals51e23135-008d-9db5-e063-6294a90a7d612026-05-15WarningsExact identifier
application number: M016
Cerave Developed with Dermatologists HealingPETROLATUMLOreal USA Products Incde44ac01-ba17-4f97-ac12-9ea348013bde2026-05-14WarningsExact identifier
application number: M016
Triple 3x Max Diaper RashZINC OXIDEAdvantice Health, LLCe554046b-cd0a-4a6e-8f24-2e610c6974322026-05-14WarningsExact identifier
application number: M016
Eczema TherapyCOLLOIDAL OATMEALSilverCeuticals3a26a35e-a098-0e22-e063-6294a90a96b92026-05-13WarningsExact identifier
application number: M016
Nail- PflasterGLYCERINShantou Ximonth Biotechnology Co., Ltd.519681bc-6312-f627-e063-6394a90a28452026-05-11WarningsExact identifier
application number: M016
HydratingPETROLATUMAldermed Inc.4aa6a354-e487-4b65-e063-6394a90abbf02026-05-09WarningsExact identifier
application number: M016
Diaper RashZINC OXIDEAldermed Inc.4aa79292-dc91-b538-e063-6294a90ac3f02026-05-09WarningsExact identifier
application number: M016
XIMONTH Nail Fungus Care LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.514a998d-aa2a-46b6-e063-6294a90a6c222026-05-08WarningsExact 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