A Health Itch Relief Gel

Product NDC
69452-376
11-digit product format
694520376
Labeler code
69452
Product ID
69452-376_463f549e-6209-3eaf-e063-6294a90a3c09
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
2022-11-08
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
A Health 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
ecf5decb-c98b-7739-e053-2995a90a5541Available 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
69452-376-55A Health Itch Relief Gel118 mL in 1 CONTAINERGEL1185

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-376A HEALTH ITCH RELIEF GEL (ITCH RELIEF GEL) GEL [BIONPHARMA, INC.]4Current NDC, Legacy NDC, 1 package rows20241220_ecf5decb-c98b-7739-e053-2995a90a5541.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 99 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti ItchANTI ITCHNeilmed Pharmaceuticals Inc.2fa74baf-e3d2-e099-e063-6394a90a1bae2025-03-06WarningsExact identifier
application number: M017
Thunder Fck Male Genital DesensitizerBENZOCAINEPRODUCT MAX GROUP INC93188a42-0d3c-4159-bdc7-bbc5ec5c67442025-03-06WarningsExact identifier
application number: M017
Body Action Climax Guard DelayBENZOCAINEPRODUCT MAX GROUP INCf88e0b42-974e-4f46-a93b-34b06320770a2025-03-06WarningsExact identifier
application number: M017
XENCARE INFLAMAX NATURAL TOPICAL PAINMENTHOL, CAPSAICINXenex Laboratories Inc.25b9621b-3c16-3cb9-e063-6294a90ab5982025-03-06WarningsExact identifier
application number: M017
Pain Relieving CreamCAMPHOR AND MENTHOLPAIN WIZARD LIMITED LIABILITY COMPANY1cd37b69-2cfb-130d-e063-6394a90af50b2025-03-06WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEWalgreens Co.c22bba5c-bb6f-494e-987a-f6e36c1b48932025-03-06WarningsExact identifier
application number: M017
Redicare Burn GelREDICARE BURN GELRedicare LLC947ac362-acfb-3508-e053-2a95a90a28732025-03-05WarningsExact identifier
application number: M017
Thera Plus Hydrocortisone Maximum StrengthHYDROCORTISONEFOURSTAR GROUP USA, INC.c2bc8f0c-38ea-4124-bc51-bf22e6751a922025-03-04WarningsExact identifier
application number: M017
Thera Plus Eczema Hydrocortisone Anti ItchHYDROCORTISONEFourstar Group USA, Inc.7c72217b-db9a-4573-9f14-4c11528fa4522025-03-04WarningsExact identifier
application number: M017
Thera Plus Maximum Strength HydrocortisoneHYDROCORTISONEFourstar Group USA, Inc.fb89dca6-c0c0-4092-b3f5-e59c956c3d6c2025-03-04WarningsExact identifier
application number: M017
Peppermint soothing creamCAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM, BORNEOLHenan Lijitang Medical Technology Co., Ltd.2f6bc332-3006-710d-e063-6394a90acea52025-03-03WarningsExact identifier
application number: M017
Thera Plus Pain Relief Arthritis and MuscleCAPSAICINFOURSTAR GROUP USA, INC.dcff0a2d-7190-4b0c-abde-ba009b8ef0052025-02-28WarningsExact identifier
application number: M017
GoodSense Anti-ItchDIPHENHYDRAMINE HCL, ZINC ACETATEGeiss, Destin & Dunn, Inc2f38bdfc-6135-1b8a-e063-6294a90a67032025-02-28WarningsExact identifier
application number: M017
Capsaicin 0.05% CreamCAPSAICIN 0.05%Puretek Corporation2cf17a28-711f-77bd-e063-6394a90a70612025-02-28WarningsExact identifier
application number: M017
Lidocaine Pain-Relief PatchesLIDOCAINE PATCHMeijer, Inc2f247929-6bff-1e59-e063-6394a90acdba2025-02-27WarningsExact identifier
application number: M017
Lightning Products BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.555ac696-e761-4a5a-bed8-945dc64d5be52025-02-27WarningsExact identifier
application number: M017
Hydrocortisone with aloeHYDROCORTISONEEncube Ethicals, Inc.12a1774d-a97e-4787-b6b1-8e8cd40b7b702025-02-26WarningsExact identifier
application number: M017
Thera Plus Maximum Strength Feminine Anti-ItchBENZOCAINE, RESORCINOLFOURSTAR GROUP USA, INC.0007e3ea-882b-4000-8e70-2bcec2c086132025-02-26WarningsExact identifier
application number: M017
Tattoo numbing creamLIDOCAINEBLOOMWELL GARDENS LLC2ea9d34e-408d-f8d6-e063-6394a90a72a42025-02-26WarningsExact identifier
application number: M017
Icy Hot Pro No-MessCAMPHOR, MENTHOLChattem, Inc.9e8fedf5-fb59-4531-b288-715f851ee05b2025-02-26WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-376-5569452037655118 mL in 1 CONTAINER (69452-376-55) 118 ml2022-11-080000-00-00NoNoCurrent