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 39 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIGHTS Insect Sting Relief PadBENZOCAINELights Medical Manufacture Co., Ltd.ccb4185c-1a67-4775-9392-16bc0f7df3cc2026-01-21WarningsExact identifier
application number: M017
Equate Pain Relieving Cream LidocaineLIDOCAINEWal-Mart Stores Inc52b91508-22aa-4c4b-94f4-977f14a01dad2026-01-20WarningsExact identifier
application number: M017
Easment advanced absorption creamCAPSAICIN 0.1%Easment LLC48de3ced-f67f-7c86-e063-6294a90a340c2026-01-20WarningsExact identifier
application number: M017
Black Cobra Tattoo NumbingSpray 4% LidocaineLIDOCAINEFoshan Sugar Max Cosmetics CO.,Ltd3605fcbf-63c8-87b5-e063-6294a90a9c3e2026-01-19WarningsExact identifier
application number: M017
Black Cobra Tattoo Numbing Cream 4% LidocaineLIDOCAINEFoshan Sugar Max Cosmetics CO.,Ltd3605961a-d596-9c4a-e063-6394a90a99dc2026-01-19WarningsExact identifier
application number: M017
Bakers Best Arthritis Pain ReliefHISTAMINE DIHYDROCHLORIDEBaker's Best Health Products, LLC869735f9-335e-4a5e-adfc-91167ae943c52026-01-19WarningsExact identifier
application number: M017
SIMPLY VITAL PAIN RELIEF HEMPMENTHOLALPHA PLANTS INCc14f4c06-cfe5-497e-9f9e-b2ba442e61bb2026-01-19WarningsExact identifier
application number: M017
AsperFlexMENTHOL AND METHYL SALICYLATEAkron Pharma Inc.117de175-976d-44f3-85ed-3d127fbe3a7c2026-01-19WarningsExact identifier
application number: M017
Equate Pain Relieving Ultra StrengthCAMPHOR, MENTHOL, METHYL SALICYLATEWal-Mart Stores Inc5ed1d7b3-925e-4a18-8e15-636f5b442ad72026-01-19WarningsExact identifier
application number: M017
Equate Medicated Pain Relieving Patch, Large 6-CountCAMPHOR, MENTHOL, METHYL SALICYLATEWalmart Stores Inc2c25cd7a-7e7b-5add-e063-6294a90a9e9b2026-01-19WarningsExact identifier
application number: M017
Equate Hydrocortione1% HYDROCORTISONEWalmart Inc.85b7f620-cc95-4333-b124-bbcc8fd5f7eb2026-01-19WarningsExact identifier
application number: M017
GuruNanda Pain ReliefMENTHOLGURUNANDA, LLC3f1d146e-0d18-7f2f-e063-6394a90ab8162026-01-19WarningsExact identifier
application number: M017
Aspercreme with LidocaineLIDOCAINEChattem, Inc.7ad8efa9-7031-4cd0-be1d-6dee63091fd12026-01-19WarningsExact identifier
application number: M017
Best Choice Targeted Warming Capsaicin Heat PatchCAPSAICINValu Merchandisers Company24ca40b7-e17b-42a3-bcc8-6861b9a5934a2026-01-18WarningsExact identifier
application number: M017
TOPCARE PAIN RELIEF PATCHESLIDOCAINETOPCO ASSOCIATES, LLCfa2f7768-e779-4409-aad3-6c33ce2e6b362026-01-18WarningsExact identifier
application number: M017
Neuropathy Pain Relief CreamMENTHOL CREAMOwell Naturals Brand, LLC48979093-2992-5fd8-e063-6394a90a815d2026-01-17WarningsExact identifier
application number: M017
CVS Lidocaine Pain Relief CreamLIDOCAINE HYDROCHLORIDECVS Pharmacy45c4f946-13b9-7a0a-e063-6394a90a73532026-01-16WarningsExact identifier
application number: M017
TopCare Pain Relieving CreamLIDOCAINE HCL 4%Topco Associates, LLC4885a7e6-a127-450a-e063-6294a90a4f912026-01-16WarningsExact identifier
application number: M017
CalmaraCALMARADynarex Corporation487393e9-6619-6033-e063-6294a90a68b22026-01-16WarningsExact identifier
application number: M017
Maximum Strength HydrocortisoneHYDROCORTISONE OINTMENTWalgreens7088092c-3a5f-4fcc-84cc-931d238f75012026-01-15WarningsExact 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