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
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	2 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ecf5decb-c98b-7739-e053-2995a90a5541	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69452-376-55	A Health Itch Relief Gel	118 mL in 1 CONTAINER	GEL	118		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-376	A HEALTH ITCH RELIEF GEL (ITCH RELIEF GEL) GEL [BIONPHARMA, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20241220_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 147 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valtrum Aerobic Sports	SALICYLIC ACID MENTHOL CAMPHOR (NATURAL)	LABORATORIOS QUANTIUM LLC	33f2491e-c1f2-4e5a-acbe-8ace844b88d6	2023-11-09	Warnings	Exact identifier application number: M017
Valtrum Topical Analgesic Roll On	SALICYLIC ACID MENTHOL CAMPHOR (NATURAL)	LABORATORIOS QUANTIUM LLC	28167e2a-9afb-44e7-90c7-9577df9504b6	2023-11-09	Warnings	Exact identifier application number: M017
Satohap Cool Type	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	fe07a00a-2699-44d3-887d-bd068948ad7b	2023-11-07	Warnings	Exact identifier application number: M017
Hims Delay Wipes	BENZOCAINE WIPES	Hims Inc.	adbead3d-dca0-4919-b688-44c88f779e5a	2023-11-07	Warnings	Exact identifier application number: M017
Bakers Best Maximum Strength Pain Relief	LIDOCAINE HYDROCHLORIDE, MENTHOL	Baker's Best Health Products, LLC	9d160ff1-9c23-4a5d-82b3-82c2e1e7d34d	2023-11-06	Warnings	Exact identifier application number: M017
BAKERS BEST Pain Relief with Pure Hemp Seed Oil	LIDOCAINE HYDROCHLORIDE, MENTHOL	BAKER'S BEST HEALTH PRODUCTS, INC.	ae54c234-bfe4-4a74-b293-db7efda7884b	2023-11-06	Warnings	Exact identifier application number: M017
Arth RX Topical Analgesic	METHYL NICOTINATE, CAPSAICIN	HCD Sales	a7b3b9b4-b1c4-4e51-8e3a-c84f64c75609	2023-11-06	Warnings	Exact identifier application number: M017
BAKERS BEST Arthritis Pain Relief Cream with Hemp and Lavender	HISTAMINE DIHYDROCHLORIDE	BAKER'S BEST HEALTH PRODUCTS, INC.	03ec87c5-6669-4afb-8d9c-c8dc9907495d	2023-11-06	Warnings	Exact identifier application number: M017
DOCTORS TOUCH Erase The Pain	MENTHOL	DOCTOR'S CHOICE MEDICAL, LLC	fe9ce2c7-d6af-4dad-b6e6-5049a9e091b0	2023-11-06	Warnings	Exact identifier application number: M017
RadiaGuard Advanced Radiation Relief	LIDOCAINE HYDROCHLORIDE	SMOOTH SIDE, INC	21205087-5a2e-41a5-be40-30cba2895408	2023-11-06	Warnings	Exact identifier application number: M017
BLUE SPRING Foot and Leg Comfort	MENTHOL	ACA MANAGEMENT LLC	5f52218d-eea4-4640-b820-84c077ab98ba	2023-11-06	Warnings	Exact identifier application number: M017
EMU THERAPY Red Hot Pepper Pain Relief Cream	MENTHOL, CAPSAICIN	ACA MANAGEMENT LLC	36293885-b2dd-4fba-9748-35a3c9e05078	2023-11-06	Warnings	Exact identifier application number: M017
ROPANA Pain Relief Cream	HISTAMINE DIHYDROCHLORIDE	FUSION PAIN SOLUTIONS LLC	e0342aa3-ca80-40b7-bec6-1b33c4db398b	2023-11-06	Warnings	Exact identifier application number: M017
EMU THERAPY Cool Menthol Therapy Pain Relief Cream	MENTHOL	ACA MANAGEMENT LLC	16894346-3513-41b1-b09f-72d84edcc4ac	2023-11-06	Warnings	Exact identifier application number: M017
SKINS DELAY Climax Control Lidocaine	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	0db91010-12f7-4f20-b96c-432915720d5a	2023-11-06	Warnings	Exact identifier application number: M017
POWERECT Lidocaine Male Delay	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	42e0c40f-1efd-45ef-815d-53d193d720eb	2023-11-06	Warnings	Exact identifier application number: M017
ARTHRO LIFE Instant Pain Relief Cream	MENTHOL	BIOBEST SERVICES LLC	66eb1a78-6861-4693-b68e-bd4a664fc075	2023-11-06	Warnings	Exact identifier application number: M017
PARACTIN QuantumActiv Pain Relief Cream	MENTHOL	NHR SCIENCE CORP	ae2f89cf-120c-4c6f-9e81-4560e6fa0373	2023-11-06	Warnings	Exact identifier application number: M017
FISICO Arthrozene Pain Cream	MENTHOL	FISICO INC.	d02c4349-78dd-4672-9582-50124ea9f1e1	2023-11-06	Warnings	Exact identifier application number: M017
BRONSON SOOTHE Pain Relief	CAPSAICIN	BRONSON NUTRITIONALS, LLC	cedf8f43-b9a3-4a06-b3a1-cf82668541f8	2023-11-06	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69452-376-55	69452037655	118 mL in 1 CONTAINER (69452-376-55)	118 ml	2022-11-08	0000-00-00	No	No	Current