DIRT Pain Relieving Gel

Product NDC: 83067-463
11-digit product format: 830670463
Labeler code: 83067
Product ID: 83067-463_097705c5-f169-19a5-e063-6294a90acfaf
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: PURIVITAE, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-10-03
Substance: MENTHOL
Active strength: 40 mg/mL
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: DIRT Pain Relieving Gel
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
415974	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
e43e2cbd-d114-4b11-8baf-7a775881cd97	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83067-463-00	DIRT Pain Relieving Gel	88 mL in 1 BOTTLE	GEL	88		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83067-463	DIRT PAIN RELIEVING GEL (MENTHOL) GEL [PURIVITAE, LLC]	2	Current NDC, 1 package rows	20231106_e43e2cbd-d114-4b11-8baf-7a775881cd97.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 149 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
INTIMALE Benzocaine Delay Gel	BENZOCAINE	SKINS SEXUAL HEALTH LIMITED	b845bfd5-ab73-495f-97ef-e959bc6311d9	2023-11-06	Warnings	Exact identifier application number: M017
RAPID PAIN-RELIEF TOPICAL	LIDOCAINE HYDROCHLORIDE, MENTHOL	NORDIC HEALTHY LIVING INC.	a06d6aca-9aa2-4bbe-bf77-4c85f1dd7870	2023-11-06	Warnings	Exact identifier application number: M017
PURE PERSONAL All Natural Pain Relief Cream	MENTHOL	PURE PERSONAL CARE, LLC	8f3fb1d0-d238-4b4c-9816-7e335258d71d	2023-11-06	Warnings	Exact identifier application number: M017
DIRT Pain Relieving Gel	MENTHOL	PURIVITAE, LLC	89c80a8f-227d-4ec0-9327-683892e73b6a	2023-11-06	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
415974	menthol 4 % Topical Gel	PSN	e43e2cbd-d114-4b11-8baf-7a775881cd97	2
415974	menthol 0.04 MG/MG Topical Gel	SCD	e43e2cbd-d114-4b11-8baf-7a775881cd97	2
415974	menthol 4 % Topical Gel	SY	e43e2cbd-d114-4b11-8baf-7a775881cd97	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83067-463-00	83067046300	88 mL in 1 BOTTLE (83067-463-00)	88 ml	2023-10-03	No	No	Current