FDA.reportPublic FDA data

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 56 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
T-Relief Lidocaine HCL 4%LIDOCAINE HCL 4%Medinatura New Mexico Inc.3c19aff8-fb18-78d0-e063-6294a90a94812025-12-11WarningsExact identifier
application number: M017
JointivaTROLAMINE SALICYLATE 10%Rising Pharma Holdings, Inc.3ee33cbf-7c0f-4982-b0b6-eeeb0202803b2025-12-11WarningsExact identifier
application number: M017
LMX4LIDOCAINEFerndale Laboratories, Inc.f0e7c92f-8b0b-4045-b659-af9f6e81260f2025-12-10WarningsExact identifier
application number: M017
HurriCaine OneTOPICAL ANESTHETIC AND ANTISEPTICBeutlich Pharmaceuticals LLC459cedbd-9b6f-e450-e063-6394a90afb732025-12-10WarningsExact identifier
application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3NICOTINE TRANSDERMAL PATCHESPCHEERY LLC45811e83-8d0b-bc2a-e063-6294a90adf502025-12-09WarningsExact identifier
application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 2NICOTINE TRANSDERMAL PATCHESPCHEERY LLC4580d7f0-92a9-d0d0-e063-6394a90ac3932025-12-09WarningsExact identifier
application number: M017
LidoGuardLIDOCAINE HCLALAINA HEALTHCARE PRIVATE LIMITEDc339dffe-bc9b-4fae-a50f-8db463d244c12025-12-09WarningsExact identifier
application number: M017
Capsaicin Cream 0.075%CAPSAICINALAINA HEALTHCARE PRIVATE LIMITED33e861bd-bb92-4aea-9d4d-1b8847c794fd2025-12-09WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEALAINA HEALTHCARE PRIVATE LIMITEDe07c5ebc-5497-4c45-acc5-d12e72e98f3f2025-12-09WarningsExact identifier
application number: M017
Ultra Strength Pain Relief BalmCAMPHOR, MENTHOLALAINA HEALTHCARE PRIVATE LIMITED80779d1f-0c2a-4ae5-9ed7-eb6877f734ba2025-12-09WarningsExact identifier
application number: M017
Pain Relief BalmMENTHOL AND CAMPHORALAINA HEALTHCARE PRIVATE LIMITED12d76b8f-4b1d-4f2d-9722-0adb55093cc42025-12-09WarningsExact identifier
application number: M017
Trojan Extended PleasureBENZOCAINEChurch & Dwight Co., Inc.be731682-4174-649a-e053-2a95a90a39872025-12-09WarningsExact identifier
application number: M017
Stopain Clinical ContinuousMENTHOLTroy Manufacturing, Inc.65f8d212-0f0e-4893-b6af-bd68bba464432025-12-09WarningsExact identifier
application number: M017
Pain and Itch Relief 4% LidocaineLIDOCAINEWalgreensf84e76a9-6af6-4fd1-be4e-efa05728cbfd2025-12-09WarningsExact identifier
application number: M017
CapsimideCAPSAICIN 0.025% TOPICAL PATCHSola Pharmaceuticalse81c2de8-6429-d681-e053-2995a90a36a92025-12-08WarningsExact identifier
application number: M017
Extra Strength Cold-Hot Medicated PatchesMENTHOLCardinal Health, 110 dba LEADERa2895c03-747c-4220-8052-4f04280626222025-12-08WarningsExact identifier
application number: M017
Leader PAIN RELIEF PATCHESLIDOCAINECardinal Health, 110 dba LEADER5feae39e-3ab8-4cda-b9e8-dc221aea24172025-12-08WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATECardinal Health, 110 dba LEADERf8837b69-8d85-448c-a4b4-be911bca1f6c2025-12-08WarningsExact identifier
application number: M017
CAPSAICIN HOT PATCHESCAPSAICINCardinal Health, 110 dba LEADER76e6bc39-643c-4264-8d98-0e4fa7d778e22025-12-08WarningsExact identifier
application number: M017
Leader PAIN RELIEF PATCHESLIDOCAINECardinal Health, 110 dba LEADER3be6defd-f429-4dc7-8b37-5910705c0b812025-12-08WarningsExact 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