FDA.reportPublic FDA data

Walgreens Original Strength Anti Itch

Product NDC
0363-4115
11-digit product format
003634115
Labeler code
0363
Product ID
0363-4115_7c06a7e8-99c2-44e1-b47a-0da5d534ceab
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride, zinc acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Walgreen Company
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-09-27
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
1; .1 g/100g; g/100g
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
2027-12-31
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
Walgreens Original Strength Anti Itch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE1 g/100g
ZINC ACETATE.1 g/100g

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
a6a49dbb-74c7-47ca-88f2-3bb3d9acf914Available 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
0363-4115-282022-02-17C16284748780-1d6a99b39-82db-a426-e053-dadaa90af4c2Walgreens Original Strength Anti Itch
0363-4115-282022-01-28C16284748780-1d6a99b39-82db-a426-e053-dadaa90af4c2Walgreens Original Strength Anti Itch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-4115-28Walgreens Original Strength Anti Itch1 in 1 CARTONCREAM112
0363-4115-28Walgreens Original Strength Anti Itch28 g in 1 TUBECREAM2812

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40WALGREENS ORIGINAL STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [WALGREEN COMPANY]1
ZINC ACETATEACTIVE INGREDIENTFM5526K07AWALGREENS ORIGINAL STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [WALGREEN COMPANY]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MWALGREENS ORIGINAL STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [WALGREEN COMPANY]1
ZINC CATIONACTIVE MOIETY13S1S8SF37WALGREENS ORIGINAL STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [WALGREEN COMPANY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TWALGREENS ORIGINAL STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [WALGREEN COMPANY]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IWALGREENS ORIGINAL STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [WALGREEN COMPANY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3WALGREENS ORIGINAL STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [WALGREEN COMPANY]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHWALGREENS ORIGINAL STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [WALGREEN COMPANY]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YWALGREENS ORIGINAL STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [WALGREEN COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RWALGREENS ORIGINAL STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [WALGREEN COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4115WALGREENS ORIGINAL STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [WALGREEN COMPANY]11Current NDC, Legacy NDC, 2 package rows20231102_a6a49dbb-74c7-47ca-88f2-3bb3d9acf914.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 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gaayou NumbingDIBUCAINE HYDROCHLORIDE 0.5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4c290118-7880-2a98-e063-6294a90a4c032026-07-21WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain Relieving Cold GelCAMPHOR, MENTHOLActive and Innovative572792bb-2819-36c3-e063-6394a90aa5042026-07-21WarningsExact identifier
application number: M017
SYLVIRENE NUMBINGLIDOCAINE 4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a36edc5-5a89-afb5-e063-6294a90a02dd2026-07-21WarningsExact identifier
application number: M017
REINREUDE PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAINLIDOCAINE 4% PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAINJiangxi Yudexi Pharmaceutical Co., LTD4a45c1cb-c5ab-d872-e063-6394a90aab5d2026-07-21WarningsExact identifier
application number: M017
SERYNTH Muscle ComfortARNICA MONTANA HPUS 7% MUSCLE COMFORTJiangxi Yudexi Pharmaceutical Co., LTD4a4c10cd-f0c4-8731-e063-6394a90a10a52026-07-21WarningsExact identifier
application number: M017
DERMFREE MEDICATED LIPCAMPHOR 2.0% MEDICATED LIPJiangxi Yudexi Pharmaceutical Co., LTD4a4d62fb-8dfa-404a-e063-6294a90a385d2026-07-21WarningsExact identifier
application number: M017
NATUHEAL RELIEF Cream FOR ECZEMAHYDROCORTISONE ACETATE 1% RELIEF CREAM FOR ECZEMAJiangxi Yudexi Pharmaceutical Co., LTD4c92fed1-a8b4-bda8-e063-6394a90a8a332026-07-20WarningsExact identifier
application number: M017
REDCOOL Arnica BruiseARNICA MONTANA HPUS 7% ARNICA BRUISEJiangxi Zhongletang Pharmaceuticals Co.,Ltd.49911392-e55e-1a6b-e063-6394a90a9af02026-07-20WarningsExact identifier
application number: M017
Vamy HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD499197aa-f872-3abf-e063-6294a90aeda22026-07-20WarningsExact identifier
application number: M017
Subleef NUMBINGLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a201a6b-adde-c0a8-e063-6394a90a82852026-07-20WarningsExact identifier
application number: M017
PUVIDA NUMBINGMENTHOL 5% (W/W) NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4de4e317-2f4f-e5d6-e063-6394a90a06112026-07-20WarningsExact identifier
application number: M017
Careland Lidocaine Plus Menthol Pain Relieving Gel PatchesLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.8b607c03-a98f-445a-a69e-7625a76ac44b2026-07-20WarningsExact identifier
application number: M017
Yodo SalilOINTMENTLaboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.56812625-7eab-6a25-e063-6294a90a23fe2026-07-20WarningsExact identifier
application number: M017
VBBV NumbingLIDOCAINEJiashen International Trade Limited5716c36b-6e97-c294-e063-6394a90aaf5c2026-07-20WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINEPremier Brands of America Inc.560c29cc-2453-5d14-e063-6394a90a844f2026-07-17WarningsExact identifier
application number: M017
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.4981e9c3-2a19-aed8-e063-6294a90af2162026-07-17WarningsExact identifier
application number: M017
endurance wipeBENZOCAINEAbsorption Pharmaceuticals, LLC303db1de-94fc-4543-e063-6294a90a01b92026-07-17WarningsExact identifier
application number: M017
Professional Therapy MuscleCare pain relieving gel Extra StrengthCAMPHOR, MENTHOLActive and Innovative Inc.56d30c33-ef5a-c63d-e063-6294a90acd292026-07-17WarningsExact identifier
application number: M017
Mineral Ice Extreme Gel Alpine Fresh ScentMENTHOLCarlin Consumer Health LLC56d3ca3d-21e1-a40a-e063-6294a90a9ff42026-07-17WarningsExact identifier
application number: M017
DRAVYNOR TOPICAL ANALGESIC HEAT PatchMENTHOL 24MG CAPSAICIN 16MG TOPICAL ANALGESIC HEAT PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56b83ee8-8d86-9436-e063-6294a90a0c252026-07-16WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1292313diphenhydrAMINE HCl 1 % / zinc acetate 0.1 % Topical CreamPSNa6a49dbb-74c7-47ca-88f2-3bb3d9acf91412
1292313diphenhydramine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical CreamSCDa6a49dbb-74c7-47ca-88f2-3bb3d9acf91412
1292313diphenhydramine hydrochloride 1 % / zinc acetate 0.1 % Topical CreamSYa6a49dbb-74c7-47ca-88f2-3bb3d9acf91412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-4115-28003634115281 TUBE in 1 CARTON (0363-4115-28) / 28 g in 1 TUBE1 tube2013-09-270000-00-00NoNoCurrent