Itch Relief Gel

Product NDC
82645-901
11-digit product format
826450901
Labeler code
82645
Product ID
82645-901_0d1cd578-e127-6e8e-e063-6294a90a5060
Type
HUMAN OTC DRUG
Nonproprietary name
Itch Relief Gel
Dosage form
GEL
Route
TOPICAL
Labeler
Pharma Nobis, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-20
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
e42f484d-a641-3489-e053-2a95a90a4254Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-901-94Itch Relief Gel118 mL in 1 CONTAINERGEL1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-901ITCH RELIEF GEL GEL [PHARMA NOBIS, LLC]2Current NDC, Legacy NDC, 1 package rows20231223_e42f484d-a641-3489-e053-2a95a90a4254.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 81 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedPride Medicated Body Powder PowderMENTHOL, ZINC OXIDEShield Line LLCcdb2fa5b-cf04-c876-e053-2a95a90a187c2025-08-15WarningsExact identifier
application number: M017
BurnLIDOCAINEHART Healthc5ff392a-e788-43e0-91ea-5e0f8420586c2025-08-15WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.40df30ba-41ba-42b7-93fe-4183b57bdb002025-08-14WarningsExact identifier
application number: M017
Signature Care Aloe Vera Gel with LidocaineLIDOCAINESafeway, Inc.d5069622-97b1-ba12-e053-2a95a90a72682025-08-14WarningsExact identifier
application number: M017
METHYL SALICYLATE 25%METHYL SALICYLATEOncora Pharma, LLC3c4bc55d-6582-3b5e-e063-6394a90a994c2025-08-13WarningsExact identifier
application number: M017
Lidocaine 3%LIDOCAINE HCL 3%PureTek Corporation3bc94d52-fe52-9fd6-e063-6294a90a43402025-08-12WarningsExact identifier
application number: M017
Fast FreezeMENTHOLNatural Essentials Inc.d8c42c8d-6ce0-43bf-b165-41979f3d8f792025-08-12WarningsExact identifier
application number: M017
Careland X-large Lidocaine 4 Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.a6867506-4a46-47b1-b5b6-bfedb59dfde62025-08-11WarningsExact identifier
application number: M017
Dermedial Anti-OuchMENTHOLSaje Natural Business Inc.3c194b8f-cfa5-11e3-e063-6394a90a92de2025-08-11WarningsExact identifier
application number: M017
Thera Plus Extra Strength Muscle Rub Topical AnalgesicMENTHOLFOURSTAR GROUP USA, INC.8a3b6adf-afbb-4d77-a19b-a6514ebd3b502025-08-11WarningsExact identifier
application number: M017
EARTHS CARE ARTHRITISCAPSAICINDLC Laboratories, Inc.9460674b-057e-40b9-a0f9-ca3d92068d4f2025-08-11WarningsExact identifier
application number: M017
LILAS PERIODMENTHOLLilas Wellness, Inc.5ea53b4b-45e6-48a7-8090-09c3a21e7f632025-08-11WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel Roll-OnLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd31639407-0f11-bde2-e063-6294a90af6942025-08-10WarningsExact identifier
application number: M017
Chinese Red Tiger Lidocaine PatchesLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd20cd369c-3e98-3d8f-e063-6394a90a08242025-08-10WarningsExact identifier
application number: M017
Treatonic LIDOCAINE PAIN RELIEFLIDOCAINE 4%100 KARMA INC3bd66b03-ac82-2d45-e063-6294a90a610a2025-08-08WarningsExact identifier
application number: M017
Capsaicin 0.025%CAPSAICIN 0.025%Advanced Rx of Tennessee, LLC3bdcef94-d06f-9152-e063-6294a90a60722025-08-08WarningsExact identifier
application number: M017
MENTHOL 5%MENTHOL 5%Advanced Rx of Tennessee, LLC3bdd0c52-29d8-ab67-e063-6294a90a9c452025-08-08WarningsExact identifier
application number: M017
Methyl Salicylate 25% CreamMETHYL SALICYLATEAdvanced Rx of Tennessee, LLC3bdd3015-349a-0fac-e063-6394a90afe412025-08-08WarningsExact identifier
application number: M017
LIDOCAINE 4%LIDOCAINE 4%Advanced Rx of Tennessee, LLC3bdd6b3d-7180-288c-e063-6394a90a17852025-08-08WarningsExact identifier
application number: M017
Good Sense Pain Relief Roll OnLIDOCAINE HCLGeiss, Destin & Dunn, Inc38e76fd6-e5fb-493c-e063-6294a90afed42025-08-08WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82645-901-9482645090194118 mL in 1 CONTAINER (82645-901-94) 118 ml2018-12-200000-00-00NoNoCurrent