FDA.reportPublic FDA data

A Health Itch Relief Gel

Product NDC
69452-496
11-digit product format
694520496
Labeler code
69452
Product ID
69452-496_380409be-9932-3933-e063-6294a90a4e72
Type
HUMAN OTC DRUG
Nonproprietary name
Itch Relief Gel
Dosage form
GEL
Route
TOPICAL
Labeler
Bionpharma, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-20
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
2026-12-31
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
A Health Itch Relief Gel
Listing expiration
2026-12-31

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
38040732-48c9-3533-e063-6394a90af10aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-496-55A Health Itch Relief Gel118 mL in 1 TUBEGEL1181

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 30 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RICHTOFIT RAPID ACTIVE ARTHRITISMENTHOL AND CAMPHORRICHTOFIT LIMITED LIABILITY COMPANY4b1cdab1-3e50-4ec3-e063-6394a90af75e2026-03-12WarningsExact identifier
application number: M017
5Kind DMSO 4 Lidocaine HCl Pain RelievingLIDOCAINE HYDROCHLORIDE, MENTHOL5KIND TRADING LTD67d8d045-7fa0-46c2-8072-645d8823903b2026-03-11WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4%RAPID AID VIET NAM COMPANY LIMITED4ca541b4-7afe-77c5-e063-6294a90ad6922026-03-10WarningsExact identifier
application number: M017
Lidocaine Cream, 4%LIDOCAINEIPG PHARMACEUTICALS, INC.7775bfdd-7eac-4f09-b83f-fc4a16a245582026-03-10WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4c989283-9a27-e8d2-e063-6294a90a8bfa2026-03-09WarningsExact identifier
application number: M017
Prequel Anti-Itch Solution Medicated CalmingMEDICATED CALMING LOTIONThe Center Brands, LLC419fa45b-992b-676e-e063-6394a90add812026-03-09WarningsExact identifier
application number: M017
Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with borderLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.1fda69f7-2bb6-42fc-bcef-677e7b3d7f012026-03-09WarningsExact identifier
application number: M017
Careland Lidocaine 4 plus menthol pain relieving gel-patches with border for kneeMENTHOL, LAUROCAPRAMPlanet (Anhui) Pharmaceutical Co., Ltd.7577625c-87eb-4639-aeab-8a2ab97033fd2026-03-09WarningsExact identifier
application number: M017
Careland Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.7de99b81-b3b3-49f1-8aa7-2ff42e1b46a42026-03-09WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4%RAPID AID VIET NAM COMPANY LIMITED4ca35030-958c-8f62-e063-6294a90a4d632026-03-09WarningsExact identifier
application number: M017
Welmate Lidocaine Pain Relieving PatchLIDOCAINEYYBA Corpcff71b75-fc4e-29ac-e053-2995a90abd502026-03-06WarningsExact identifier
application number: M017
Heal and Rescue Bunion Pain ReliefLIDOCAINE HCL, MENTHOLRooftop Consumer Health, Inc4c60d4d3-e0a9-6f93-e063-6394a90a16af2026-03-06WarningsExact identifier
application number: M017
JUST CBD - PAIN RELIEFMENTHOL, CAMPHORJust Brands LLC4c493c0b-c58e-cb56-e063-6394a90a93952026-03-05WarningsExact identifier
application number: M017
Hug a BooBoo Medicated booboo WipesBENZOCAINELights Medical Manufacture Co., Ltd.509aaafc-2ef7-4205-818c-7ff5b146e1592026-03-04WarningsExact identifier
application number: M017
CVS Foot PainLIDOCAINE HYDROCHLORIDECVS Pharmacy4c3350c3-2e3e-093c-e063-6394a90a34752026-03-04WarningsExact identifier
application number: M017
Game On SportMENTHOLNatural Essentials, Inc4c3411dc-5378-bd93-e063-6394a90a84062026-03-04WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONETrifecta Pharmaceuticals Usa Llcf4d4a56b-b4b7-9a07-e053-2a95a90ad8532026-03-04WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONETrifecta Pharmaceuticals Usa Llc9987165c-1a0f-dd57-e053-2a95a90ae7352026-03-04WarningsExact identifier
application number: M017
Walgreens Unscented Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLWalgreen Co.41eadb4f-2ca5-42a1-e063-6294a90ab4e22026-03-04WarningsExact identifier
application number: M017
Careland Pain Relief Patch PlusLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.d55d8a9e-ed2b-4c9b-9ecb-6ec1fd43c9e32026-03-04WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69452-496-5569452049655118 mL in 1 TUBE (69452-496-55) 118 ml2025-06-20NoNoCurrent