Home NDC 83067-463 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.
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 117 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Walgreens Flexible Pain Relieving Lidocaine LIDOCAINE, MENTHOL Walgreen Co. 6f070fa3-a61a-4523-a470-ab58bf9400a3 2024-11-27 Warnings Exact identifier application number: M017 Benadryl Original Strength Itch Stopping DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Kenvue Brands LLC 920c50cb-9bdd-4a36-bb3d-c2559db73327 2024-11-26 Warnings Exact identifier application number: M017 Universal ARTHRITIS and SPORT METHYL SALICYLATE, CAPSICUM Universal Distribution Center LLC 884907a8-c884-4cce-ac10-9d4848fdba3e 2024-11-22 Warnings Exact identifier application number: M017 Universal ARTHRITIS and SPORT METHYL SALICYLATE, CAPSICUM Universal Distribution Center LLC 7f067e95-e01c-4b9a-a02e-0af097beb18c 2024-11-22 Warnings Exact identifier application number: M017 Universal ARTHRITIS and SPORT METHYL SALICYLATE, CAPSICUM Universal Distribution Center LLC 9ece9b3a-0092-4c1c-a913-c2fefcd70541 2024-11-22 Warnings Exact identifier application number: M017 Sting Relief Pad BENZOCAINE, ISOPROPYL ALCOHOL Changzhou Maokang Medical Products Co., Ltd 1936c5f4-274b-8e49-e063-6394a90ac642 2024-11-21 Warnings Exact identifier application number: M017 Hempvana Ultra Strength Pain Relief Cream Platinum 4% Lidocaine LIDOCAINE 4% Telebrands Corp 2788189e-35bc-d48c-e063-6294a90ae6c2 2024-11-21 Warnings Exact identifier application number: M017 Family Wellness Ultra Strength Muscle Rub ULTRA STRENGTH MUSCLE RUB FAMILY DOLLAR (Family Wellness) 554c7d3c-09f4-4923-b4ca-d5de8f7e2c9a 2024-11-21 Warnings Exact identifier application number: M017 Family Wellness Anorectal Lidocaine ANORECTAL LIDOCAINE FAMILY DOLLAR (Family Wellness) ed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d 2024-11-21 Warnings Exact identifier application number: M017 Family Wellness Hot and Cold Pain Relief HOT AND COLD PAIN RELIEF FAMILY DOLLAR (Family Wellness) b70e343b-18aa-4e45-ae8e-79d8c84ad205 2024-11-21 Warnings Exact identifier application number: M017 Signature Care Lidocaine Cream LIDOCAINE Better Living Brands LLC 5483729e-ef1a-47a2-b7cf-c19744f52073 2024-11-21 Warnings Exact identifier application number: M017 WINCO Hydrocortisone HYDROCORTISONE 1% WinCo Foods LLC 26a29de3-4b79-4a3a-93b6-a14c5e91a8c6 2024-11-21 Warnings Exact identifier application number: M017 Menthol and Zinc Oxide MENTHOL AND ZINC OXIDE Dynarex Corporation d0e43651-4215-465b-9ace-1bc23126b109 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Cold As Ice Pain Relief Gel-Patch MENTHOL Telebrands Corp 976a1bb2-b776-8199-e053-2995a90a1a1b 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief TROLAMINE SALICYLATE TELEBRANDS CORP d91a0fad-a38c-1580-e053-2a95a90ad268 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief - Platinum TROLAMINE SALICYLATE TELEBRANDS CORP d58da6c5-47a6-b8a8-e053-2995a90a7ce7 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Knee Bird Ultra Strength Pain Relief LIDOCAINE, MENTHOL TELEBRANDS CORP df5d3312-cbc5-5db9-e053-2995a90ab055 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Cold as Ice Gel MENTHOL Telebrands Corp a9e103f2-778f-e49b-e053-2a95a90aa8b7 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Knee Bird Ultra Strength Pain Relief LIDOCAINE, MENTHOL TELEBRANDS CORP d58e2c47-c0f4-625e-e053-2a95a90aa4d5 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Pain Relief TROLAMINE SALICYLATE Telebrands Corp 92a29553-a102-0a0e-e053-2a95a90ab24a 2024-11-20 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# 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