A Health Itch Relief Gel

Product NDC
69452-376
Requested package NDC
69452-376-55
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 97 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Herb AnalgesicHERB ANALGESIC PASTEChangsha Maocheng Trading Co., Ltd29373587-9eff-6ea0-e063-6394a90a23b22025-03-18WarningsExact identifier
application number: M017
DEBACHERE Butt Balm After Play Care Multi Symptoms ReliefBENZOCAINE, BENZALKONIUM CHLORIDEDE.BACHERE USA LLCf469b446-58a0-4be3-884f-d622b9d074f82025-03-17WarningsExact identifier
application number: M017
Auvon 4% Menthol Pain Relief GelMENTHOLSHENZHEN YUWEN E-COMMERCE CO., LTD.2dacd6fe-7d69-bcf0-e063-6294a90a03512025-03-14WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limited1ee49cad-84d4-42cf-aa83-c0da6f1b1b842025-03-14WarningsExact identifier
application number: M017
AY BENDITO THERMOACTIVEMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC304d71b6-91c8-b2b6-e063-6394a90ab6692025-03-14WarningsExact identifier
application number: M017
Hot/Cold Medicated PatchHOT COLD PATCHDynarex999881b3-287e-d975-e053-2995a90a87e32025-03-14WarningsExact identifier
application number: M017
Capsaicin 0.025%CAPSAICIN 0.025%Marcella Health3054e7fd-cab2-7f77-e063-6294a90a498d2025-03-14WarningsExact identifier
application number: M017
MENTHOL 5%MENTHOL 5%Marcella Health30914c0a-fbda-5674-e063-6294a90aba5b2025-03-14WarningsExact identifier
application number: M017
Peppermint Soothing PatchCAMPHORIC ACID, MENTHOL, UNSPECIFIED FORMHenan Lijitang Medical Technology Co., Ltd.30361dd4-1f3d-ac5e-e063-6294a90a23bc2025-03-13WarningsExact identifier
application number: M017
AVCOO Menthol Pain Relief PatchMENTHOLADP Health Limited3036804b-16c3-0c88-e063-6394a90a30842025-03-13WarningsExact identifier
application number: M017
LIDOCAINE 4%LIDOCAINE 4%Marcella Health303d9462-cbfb-6251-e063-6394a90a70652025-03-13WarningsExact identifier
application number: M017
XeroBurn Burn GelLIDOCAINE HYDROCHLORIDEDynarex Corporation58985046-ca9c-12be-e053-2991aa0abe722025-03-13WarningsExact identifier
application number: M017
Post Treatment Repair CreamHYDROCORTISONEVege Labs LLC.302d4327-354b-a252-e063-6394a90a20b62025-03-12WarningsExact identifier
application number: M017
TheraCare Pain Relief 4% LidocaineLIDOCAINEVeridian Healthcare2d3fc030-5d53-2acd-e063-6294a90a11ab2025-03-11WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLVeridian Healthcare2d413707-794c-2fa8-e063-6394a90a06bf2025-03-11WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLVeridian Healthcare2d04799f-946d-ac53-e063-6294a90afeb72025-03-11WarningsExact identifier
application number: M017
Muscle and Joint CareLIDOCAINEVege Labs LLC.301966b5-b535-dc04-e063-6394a90aec172025-03-11WarningsExact identifier
application number: M017
Arctic Blast Pain ReleivingMENTHOL, CAMPHOR (SYNTHETIC)Nutriomo Labs Pte, Ltdd5e7d26d-4f63-4b7b-a173-fe3a794c84592025-03-10WarningsExact identifier
application number: M017
Anti ItchWALGREENWalgreens30014ff0-2519-4031-e063-6394a90ae07b2025-03-10WarningsExact identifier
application number: M017
Anti ItchANTI ITCHNeilmed Pharmaceuticals Inc.2fa74baf-e3d2-e099-e063-6394a90a1bae2025-03-06WarningsExact 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