Home NDC 83067-363 DIRT Pain Relieving Gel
Product NDC 83067-363
11-digit product format 830670363
Labeler code 83067
Product ID 83067-363_09770368-70f8-2f7c-e063-6294a90a81ff
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form GEL
Route TOPICAL
Labeler PURIVITAE, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-10-03
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 83067-363-00 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 83067-363 DIRT PAIN RELIEVING GEL (MENTHOL) GEL [PURIVITAE, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20231106_89c80a8f-227d-4ec0-9327-683892e73b6a.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 148 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 ndc (product): 83067-363 DIRT Pain Relieving Gel MENTHOL PURIVITAE, LLC e43e2cbd-d114-4b11-8baf-7a775881cd97 2023-11-06 Warnings Exact identifier application number: M017 Celadrin Joint and Muscle Pain Relieving MENTHOL Factors Group of Nutritional Products 6396e4b6-2130-433b-bdb3-97c76dbe685c 2023-11-06 Warnings Exact identifier application number: M017 Atomic Balm METHYL SALICYLATE, CAPSAICIN The Hygenic Company, LLC d10028f3-ae6a-7b01-e053-2995a90a5a84 2023-11-05 Warnings Exact identifier application number: M017 HEMPCIN Advanced Topical Pain Relief Cream MENTHOL Pedicis Research, LLC 97f5e300-b780-4694-a681-60d5e0cfad65 2023-11-05 Warnings Exact identifier application number: M017 Point Relief cold Spot Pain Relieving roll-on MENTHOL Fabrication Enterprises 3f1db0ad-aaa8-4e14-9349-45057e0fb4a6 2023-11-05 Warnings Exact identifier application number: M017 LidoStat LIDOCAINE HCL Clinical Therapeutic Solutions 1825885b-9141-4515-bb69-a1c4a39fb10d 2023-11-05 Warnings Exact identifier application number: M017 Point Relief Cold Spot Pain Relieving MENTHOL Fabrication Enterprises 391af69f-74aa-48cf-bc96-75e5c4e0e445 2023-11-05 Warnings Exact identifier application number: M017 FEEL GOOD LABS NATURAL PAIN MENTHOL The Feel Good Lab 778b62a1-ebd3-4a30-8f76-6d6773b698c5 2023-11-05 Warnings Exact identifier application number: M017 FEEL GOOD LABS SPORT RECOVERY MENTHOL The Feel Good Lab 103c5e33-42fb-41ac-957e-bb46d85e204c 2023-11-05 Warnings Exact identifier application number: M017 INSTA RELIEF DM LIDOCAINE HYDROCHLORIDE, MENTHOL DM LAB CORP 6ef66fb9-9f49-409d-9503-175c7555ee9e 2023-11-05 Warnings Exact identifier application number: M017 DR. MIKES Ponos Pain Relief Cream Roll-On HISTAMINE DIHYDROCHLORIDE, MENTHOL Dr. Mike's Vitamins, LLC fcc45464-f1fe-4244-95a7-9b4288b0ce45 2023-11-05 Warnings Exact identifier application number: M017 AcuPlus Pain Relief MENTHOL Innovations for Wellness, LLC 7f222a4f-85a8-4f3d-aa97-5c695d4da37f 2023-11-05 Warnings Exact identifier application number: M017 Ana Cool Rapid Soothing Cooling Formula HYDROCORTISONE Ana-Cool, LLC 64b80cc2-e2d8-4535-aaf8-c031f4159cd1 2023-11-05 Warnings Exact identifier application number: M017 FEEL GOOD LABS SPORT RECOVERY MENTHOL THE FEEL GOOD LAB, LLC 19b08cbf-5f43-4f07-8f4d-8cddb1492ab8 2023-11-05 Warnings Exact identifier application number: M017 PlayMakar Roll On Cool Pain Relief MENTHOL PlayMakar Inc. a12c16e7-561f-45a7-93c6-34d693ffdc7c 2023-11-05 Warnings Exact identifier application number: M017 AcuPlus Advanced Therapy for Pain and Recovery MENTHOL INNOVATIONS FOR WELLNESS, LLC 840cfd15-4ea1-49bf-8c4f-86c12461d860 2023-11-05 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 Marketing end Sample Exclude flag Status 83067-363-00 83067036300 88 mL in 1 BOTTLE (83067-363-00) 88 ml 2022-10-03 0000-00-00 No No Current