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 102 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
K19 RELIEFMENTHOLK19 LLCe2e1ca96-1ae8-4c99-b8de-ce26754292f92025-01-15WarningsExact identifier
application number: M017
AnecreamLIDOCAINE 4%Focus Health Group2d7706e2-7363-4047-96cb-85b718277e8c2025-01-15WarningsExact identifier
application number: M017
BoroleumCAMPHOR, MENTHOL, WHITE PETROLATUMReliable 1 Laboratories846568af-0fdd-a80e-e053-2a91aa0a9c9e2025-01-15WarningsExact identifier
application number: M017
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEAdvanced Rx of Tennessee, LLC27d5997b-1cc2-41c2-e063-6394a90ac74a2025-01-15WarningsExact identifier
application number: M017
Pain Relief Patch 4% LidocaineLIDOCAINEReliable 1 Laboratories LLC2b624763-c310-63d9-e063-6394a90a19282025-01-15WarningsExact identifier
application number: M017
Cannarelief 1000mgMENTHOLCarolina Cannabis Creations LLC01e2ae1a-c969-6dd2-e063-6394a90a9d9e2025-01-15WarningsExact identifier
application number: M017
Healing Hand Cream 2000mgMENTHOLCarolina Cannabis Creations LLC01f8795b-9f95-c793-e063-6394a90a83302025-01-15WarningsExact identifier
application number: M017
CBD Clinic Deep-Rub Pain Relief - Level 5CAMPHOR, MENTHOLABACUS HEALTH PRODUCTS, INC.31e2e5cd-d33e-f058-e063-6394a90af7d22025-01-14WarningsExact identifier
application number: M017
Meijer Odor Free Analgesic Pain Relieving Topical AnalgesicLIDOCAINE HYDROCHLORIDEMeijer Distribution, Inc6288efea-f636-4eea-bb9f-78aa2f9af54a2025-01-14WarningsExact identifier
application number: M017
IKONIK TONIKLIDOCAINE HYDROCHLORIDEIKONIK CARE, LLC122fdfe8-b5fa-46d1-9fd9-3df9887ed3202025-01-14WarningsExact identifier
application number: M017
elp essential MANTECA DE UBREMETHYL SALICYLATE, CAMPHORMiramar Cosmetics, Inc DBA Miramar Labc3964dfe-17fe-4d89-a4c4-cf500f9822592025-01-13WarningsExact identifier
application number: M017
MethyltenMETHYL SALICYLATE 10%Puretek Corporation28f4093f-803f-0e70-e063-6294a90a98a42025-01-13WarningsExact identifier
application number: M017
Refill Bundle 7 Large OfficeBENZALKONIUM CHLORIDECMC Group, Inc.6620a8f3-098d-d045-e053-2a91aa0a0d942025-01-13WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Zanming Trading Co., Ltd.2ba1de83-494a-6c54-e063-6294a90a9b2d2025-01-13WarningsExact identifier
application number: M017
Arthritis HotMENTHOL AND METHYL SALICYLATEChattem, Inc.cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd2025-01-13WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b40dda-53ad-0458-e063-6394a90aa8352025-01-11WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b47eb7-6b43-d9e2-e063-6294a90a9a382025-01-11WarningsExact identifier
application number: M017
Re-Lieved 4% Lidocaine Fabric TapeLIDOCAINE 4% FABRIC TAPETransfer Technologye9a894b0-54f2-707e-e053-2a95a90a0f0d2025-01-11WarningsExact identifier
application number: M017
Re-Lieved 3 in 1 PatchMENTHOL, CAMPHOR, METHYL SALICYLATE PATCHTransfer Technologye9ab9a03-b9e3-7317-e053-2995a90a99502025-01-11WarningsExact identifier
application number: M017
ASTRAPHARM CHILLI BRANDCAPSAICINDersan Pharmaceutical Co., Ltdb4c2d4fd-7d5d-4156-ac27-e72ebc9671ec2025-01-10WarningsExact 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