Itch Relief Gel

Product NDC
0363-0353
11-digit product format
003630353
Labeler code
0363
Product ID
0363-0353_485ea50e-b62a-cbb9-e063-6394a90a1cdf
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
GEL
Route
TOPICAL
Labeler
Walgreens
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-30
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
2 mg/100mL
Pharmacologic classes
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
Itch Relief Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE2 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
487060a7-dff3-4840-b967-ca919f8d0a29Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0353-042024-02-20C16284748780-11030e365-5379-111a-e063-dadaa90a10e2Walgreens Itch Relief Gel
0363-0353-042024-01-30C16284748780-11030e365-5379-111a-e063-dadaa90a10e2Walgreens Itch Relief Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0353-04Itch Relief Gel103.5 mL in 1 TUBEGEL103.56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0353ITCH RELIEF GEL (DIPHENHYDRAMINE HCL) GEL [WALGREENS]5Current NDC, Legacy NDC, 1 package rows20240306_487060a7-dff3-4840-b967-ca919f8d0a29.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 12 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natures Willow Balm Roll On Pain ReliefMENTHOLWB Ventures LLC3b1834e6-75cd-5380-e063-6294a90ad1d52026-07-08WarningsExact identifier
application number: M017
Natures Willow Balm Itch Relief CreamMENTHOLWB Ventures LLC0ce31b5d-4401-460c-e063-6394a90ab5582026-07-08WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Inc.560a4abf-31dd-333f-e063-6294a90a35052026-07-08WarningsExact identifier
application number: M017
Natures Willow BalmMENTHOLWB VENTURES LLCb9f50c43-b0d5-39a8-e053-2995a90a04f12026-07-08WarningsExact identifier
application number: M017
Natures Willow Bug Bite BalmMENTHOLWB Ventures LLCb9fab18f-32c7-d5bd-e053-2995a90a6d0f2026-07-08WarningsExact identifier
application number: M017
Salonpas pain relieving hotCAPSAICIN, MENTHOLHisamitsu Pharmaceutical Co., Inc.d2aa8820-a947-404b-b617-e692fbd165022026-07-07WarningsExact identifier
application number: M017
Quali Yi Tiao Gen Pain PatchCAPSAICIN PATCHSheng Chang Pharmaceutical Co, Ltd. Zhongli Factory33154a9b-f6d0-4e95-b4cb-6b938f5dcf4d2026-07-07WarningsExact identifier
application number: M017
MUYOHON Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.55caf0a5-f062-a6c3-e063-6294a90ae0732026-07-04WarningsExact identifier
application number: M017
Targeted Warming Capsaicin PatchCAPSAICINArmy & Air Force Exchange Service55b539f8-38c4-594e-e063-6394a90afbaa2026-07-03WarningsExact identifier
application number: M017
TopCare Health Pain ReliefLIDOCAINE HYDROCHLORIDETopco Associates LLC485b0671-da09-19d7-e063-6294a90aca5d2026-07-03WarningsExact identifier
application number: M017
Mineral Ice Methol Pain ReliefMENTHOL 10.5 %Sunflora Inc6ddd9e97-f717-4d5a-9658-26449a3cc8312026-07-02WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINEAmerisourceBergen Drug Corporation7d898e33-ded7-c9b9-e053-2a91aa0adf7c2026-07-01WarningsExact identifier
application number: M017
Desert Harvest Releveum with LidocaineLIDOCAINE HYDROCHLORIDEDesert Harvest, Inc9ad514ab-a6bd-4564-8ba3-0149032ebf362026-07-01WarningsExact identifier
application number: M017
CVS No Mess CortisoneHYDROCORTISONENatural Essentials, Inc.558c94ec-95f1-eb98-e063-6394a90a1e722026-07-01WarningsExact identifier
application number: M017
MUSCLE EASEMENTHOL CAMPHORSOMBRA COSMETICS INC.03fff4bf-04ed-49a6-b40f-4d98c2b42f692026-07-01WarningsExact identifier
application number: M017
OrthoNesic Pain Relieving GelMENTHOL, CAMPHORBlaine Labs Inc.122f60c2-f8df-4625-8bb8-a2244a261b5d2026-07-01WarningsExact identifier
application number: M017
Desert Harvest RELEVEUMLIDOCAINEDesert Harvest Inc.5d9010ec-d482-44ff-ba27-3bfec5a241c62026-06-30WarningsExact identifier
application number: M017
PromescentLIDICAINEAbsorption5b508238-3be7-4b0d-bf35-51de79f58f552026-06-30WarningsExact identifier
application number: M017
LidovyxLIDOCAINE 4%V2 Pharma LLC4465eb60-a617-4608-9504-8b3b4c64f49e2026-06-30WarningsExact identifier
application number: M017
Dr.Johnes Lidocaine 4% Topical Analgesic CreamLIDOCAINE HCL,MENTHOLDr.Johnes LLC6144708d-4b0f-4f0d-88e3-6925ba2d004d2026-06-29WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0353-0400363035304103.5 mL in 1 TUBE (0363-0353-04) 103.5 ml2018-05-300000-00-00NoNoCurrent