FDA.reportPublic FDA data

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
IngredientStrength
MENTHOL40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e43e2cbd-d114-4b11-8baf-7a775881cd97Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83067-463-00DIRT Pain Relieving Gel88 mL in 1 BOTTLEGEL882

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83067-463DIRT PAIN RELIEVING GEL (MENTHOL) GEL [PURIVITAE, LLC]2Current NDC, 1 package rows20231106_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 71 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First Hydrocortisone 1%HYDROCORTISONE ACETATE 1%Unifirst First Aid Corporationf2b46d69-1c21-5ae9-e053-2a95a90a60a92025-10-24WarningsExact identifier
application number: M017
Extra StrengthMENTHOL AND METHYL SALICYLATESaje Natural Business Inc.87d872b3-3231-d0f2-e053-2995a90a9d982025-10-24WarningsExact identifier
application number: M017
Coralite Muscle and Joint Pain ReliefCAMPHOR, MENTHOL, AND MEHTYL SALICYLATEUnited Exchange Corporation78edeeb8-3e3c-64bb-e053-2a91aa0a7bbc2025-10-24WarningsExact identifier
application number: M017
Coralite Odor Free Pain ReliefLIDOCAINEUnited Exchange Corporation7966d9f2-22f9-a900-e053-2991aa0aba552025-10-24WarningsExact identifier
application number: M017
Signature Care Cold and HotMENTHOL, AND METHYL SALICYLATESafeway Inc.ab201023-e3dc-52ec-e053-2995a90a1f182025-10-24WarningsExact identifier
application number: M017
HealthWise Medicated Cold Hot 5% PatchMENTHOLVeridian Healthcare15aef56f-cd25-05ac-e063-6394a90a07bb2025-10-23WarningsExact identifier
application number: M017
AlivioLIDOCAINEAmerise Pharmaceuticals LLCeb3a98f1-c875-4f08-8b4b-44e22626b6092025-10-23WarningsExact identifier
application number: M017
Pain Relieveing Gel-PatchLIDOCAINEBullet point LLC41d507c4-ad37-2686-e063-6394a90aae5b2025-10-23WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP98fa9a34-0e1e-0997-e053-2a95a90ac77d2025-10-23WarningsExact identifier
application number: M017
Coralite Pain Relief HotMENTHOL AND CAPSAICINUnited Exchange Corporation78eb133d-01bb-6466-e053-2991aa0accc02025-10-23WarningsExact identifier
application number: M017
AmericaineBENZOCAINEInsight Pharmaceuticals LLC4fd14452-0285-40c4-b835-36935c2056b22025-10-23WarningsExact identifier
application number: M017
zourunan PAIN RELIEFPAIN RELIEFGuchutang Biotechnology (Longyan) Co., Ltd41bc1c0c-63d5-0d41-e063-6394a90a341b2025-10-22WarningsExact identifier
application number: M017
zourunan PAIN RELIEFPAIN RELIEFGuchutang Biotechnology (Longyan) Co., Ltd41bd0769-6ba0-d0d5-e063-6294a90af7c92025-10-22WarningsExact identifier
application number: M017
Coralite Extra Strength Pain Relief Sleeve KneeMENTHOLUnited Exchange Corp.aa5873bd-af64-41cc-8f16-7714c56bca962025-10-22WarningsExact identifier
application number: M017
Family Care Muscle RubCAMPHOR, MENTHOL, AND METHYL SALICYLATEUnited Exchange Corp.63006bb5-76e8-eb64-e053-2991aa0a95ad2025-10-22WarningsExact identifier
application number: M017
Winco Cold and Hot Medicated Patch LargeMENTHOLWINCO FOODS, LLCaf0d86c4-f74e-2dbe-e053-2a95a90a74c12025-10-22WarningsExact identifier
application number: M017
Coralite Cold and HotMENTHOLUnited Exchange Corp.064a6149-a0e2-8a73-e063-6394a90a79532025-10-22WarningsExact identifier
application number: M017
Topical AnalgesicMENTHOLYoungevity International Inc.b4693947-f5b3-6fd3-e053-2995a90ab5812025-10-22WarningsExact identifier
application number: M017
PAIN RELIEVINGLIDOCAINEMedhome Pharma Inc41cb1135-84e0-0c9a-e063-6294a90ada962025-10-22WarningsExact identifier
application number: M017
KINKANAMMONIA, CAMPHOR (NATURAL), MENTHOLKINKANDO CO., LTD .f2c0f3e1-792b-4798-bf6d-acd1bbefa2612025-10-21WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSNe43e2cbd-d114-4b11-8baf-7a775881cd972
415974menthol 0.04 MG/MG Topical GelSCDe43e2cbd-d114-4b11-8baf-7a775881cd972
415974menthol 4 % Topical GelSYe43e2cbd-d114-4b11-8baf-7a775881cd972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83067-463-008306704630088 mL in 1 BOTTLE (83067-463-00) 88 ml2023-10-03NoNoCurrent