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 95 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUSCLEMENTHOLWATER-JEL TECHNOLOGIES1af399af-07b0-4899-9bcc-1e244b63b1cf2025-04-08WarningsExact identifier
application number: M017
Lidocaine with MentholLIDOCAINE HCL AND MENTHOLKareway Product, Inc.9ee46a5b-d00c-4254-e053-2995a90aeb3a2025-04-08WarningsExact identifier
application number: M017
Foster and Thrive Lidocaine Pain Relief PatchLIDOCAINE 4%Strategic Sourcing Services LLC324802c9-e2c2-bf74-e063-6394a90a86972025-04-08WarningsExact identifier
application number: M017
OARS AND ALPS MUSCLE RECOVERY BALMMENTHOL, METHYL SALICYLATECosco International, Inc8745802f-018d-4cf8-bbf3-3b04c8f545382025-04-08WarningsExact identifier
application number: M017
NOVUM APRMENTHOLNOVUM SOLUTIONS INC1b869a1f-5787-4d03-a546-43a8217b2b2c2025-04-07WarningsExact identifier
application number: M017
MAG 5 PT ROLL-ON PAIN RELIEF COOLINGMENTHOLRENU LABORATORIES, LLC31e4fa2c-3a98-d618-e063-6394a90aec1c2025-04-07WarningsExact identifier
application number: M017
RockSauce FIERY HOT PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAPSAICINImplus Footcare, LLCcc7cbf4a-8274-e463-e053-2995a90a51e02025-04-07WarningsExact identifier
application number: M017
RockSauce FIERY HOT PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAPSAICINImplus Footcare, LLCbdee018a-2c3c-3116-e053-2a95a90ac8d82025-04-07WarningsExact identifier
application number: M017
RockSauce FIERY HOT PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAPSAICINImplus Footcare, LLCbdee2b65-2759-0e62-e053-2a95a90a03782025-04-07WarningsExact identifier
application number: M017
RockSauce ICY COLD PAIN RELIEFMENTHOLImplus Footcare, LLCbdc7c7f3-ac98-8fe9-e053-2a95a90a26632025-04-07WarningsExact identifier
application number: M017
RockSauce ICY COLD PAIN RELIEFMENTHOLImplus Footcare, LLCbd4fdff1-9174-31c2-e053-2a95a90a749f2025-04-07WarningsExact identifier
application number: M017
GREEN GUARD Topical Pain ReliefLIDOCAINE HCIUltra Distributors Incb6f0041c-47fc-0bcd-e053-2a95a90ab1f92025-04-07WarningsExact identifier
application number: M017
CBD Clinic Pain Relief - Level 5MENTHOL, CAMPHORABACUS HEALTH PRODUCTS, INC.f0ebc1c6-93fb-efd6-e053-2995a90a25bb2025-04-07WarningsExact identifier
application number: M017
CBD Clinic Pain Relief - Level 4MENTHOL, CAMPHORABACUS HEALTH PRODUCTS, INC.f0e9ac7c-a840-2e05-e053-2a95a90a33f12025-04-07WarningsExact identifier
application number: M017
CBDMEDIC Active Sport Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec5f47-2f8e-0558-e053-2a95a90aa7ca2025-04-07WarningsExact identifier
application number: M017
Hot Cold Medicated PatchesHOT COLD MEDICATED PATCHESHenan Enokon Medical Instrument Co., Ltd.159266a8-94fa-e2ff-e063-6394a90a9a772025-04-02WarningsExact identifier
application number: M017
Pain Relief PatchPAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.1592d29d-e275-a44d-e063-6294a90ab17d2025-04-02WarningsExact identifier
application number: M017
JointflexCAMPHORStrides Consumer LLC766b73f2-67bd-4d5c-805c-1057b3981ebf2025-04-02WarningsExact identifier
application number: M017
Olu Pain ManagementLIDOCAINE AND CAMPHORAsclemed USA, Inc.d4d556c1-b64b-4b8e-8e4b-4f40eda242502025-04-01WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine SalicylateTROLAMINE SALICYLATETELEBRANDS CORP31ce185e-07b7-d837-e063-6394a90a1fb02025-04-01WarningsExact 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