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 124 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Wegmans Aloe After Sun Gel with Lidocaine HCl External Analgesic LIDOCAINE HYDROCHLORIDE WEGMANS FOOD MARKETS INC f70bc438-7ed8-f74d-e053-6394a90a2b3f 2024-10-16 Warnings Exact identifier application number: M017 EQUATE Sunburn relief with Aloe After Sun LIDOCAINE Wal-Mart Stores Inc c25e1288-7ac6-41fc-ab65-26c379f288a7 2024-10-16 Warnings Exact identifier application number: M017 Genuine First Aid Insect Sting Relief Pad 1 ct BENZOCAINE, ALCOHOL GFA Production (Xiamen) Co., Ltd. b119ba37-0ee1-851a-e053-2995a90a85b1 2024-10-15 Warnings Exact identifier application number: M017 PAIN RELIEF PATCHES LIDOCAINE Walgreen Company 1a587e6e-88d1-4b01-abad-9a365dc64a4d 2024-10-15 Warnings Exact identifier application number: M017 TopCare Everyday After Sun Cooling LIDOCAINE HYDROCHLORIDE TOPCO ASSOCIATES LLC baff7293-e1a3-d1f2-e053-2995a90a93ca 2024-10-15 Warnings Exact identifier application number: M017 Universal PAIN RELIEF LIDOCAINE Universal Distribution Center LLC b132a4f2-1b1f-4e80-a183-f9add449065f 2024-10-14 Warnings Exact identifier application number: M017 Nervex Pain Relieving CAPSAICIN VITA SCIENCES, LLC a39bba22-8c54-4252-9973-052dd2aaea36 2024-10-14 Warnings Exact identifier application number: M017 CVS Health Lidocaine Pain-Relieving LIDOCAINE NATURAL ESSENTIALS, INC. d07fdffd-bf7c-4950-9b2d-c06d54ef4c55 2024-10-14 Warnings Exact identifier application number: M017 Walgreens Cooling LIDOCAINE HYDROCHLORIDE WALGREEN COMPANY baffb272-436c-4ad8-e053-2a95a90a56fb 2024-10-14 Warnings Exact identifier application number: M017 Walgreens Sunburn Relief MENTHOL WALGREEN COMPANY c8967fba-6c28-494b-e053-2995a90acbba 2024-10-14 Warnings Exact identifier application number: M017 Walgreens Sunburn Relief LIDOCAINE WALGREEN COMPANY d5067903-c559-dc6d-e053-2995a90a8ee3 2024-10-14 Warnings Exact identifier application number: M017 Diphenhydramine HCl and Zinc Acetate EXTRA STRENGTH ITCH RELIEF Meijer Distribution Inc 18998e1c-1254-4d0c-93f1-26652c5ca076 2024-10-14 Warnings Exact identifier application number: M017 signature care itch relief DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Safeway 3eedcd9f-8312-4d14-a0fe-6b00a00d3e73 2024-10-13 Warnings Exact identifier application number: M017 itch relief DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE H E B 34c7bcd3-203f-4630-894d-3739a1576c8d 2024-10-13 Warnings Exact identifier application number: M017 hydrocortisone HYDROCORTISONE H E B 25ec9014-64c4-44df-9e67-9f9223ffc923 2024-10-12 Warnings Exact identifier application number: M017 PAIN RELIEF Gel-Roll On LIDOCAINE AND MENTHOL Shanghai Chuangshi Medical Technology (Group) Co., Ltd. f02fa9c0-b8af-f362-e053-2a95a90ae516 2024-10-11 Warnings Exact identifier application number: M017 Insect Sting Relief Pad BENZOCAINE, ALCOHOL Hubei Changjian Medical Products Co., Ltd. 6a269982-0e25-4c09-aef1-0b398bdc5ed4 2024-10-11 Warnings Exact identifier application number: M017 HYDROCORTISONE HYDROCORTISONE VIVE HEALTH LLC 24221805-e5c9-5785-e063-6394a90a9d2f 2024-10-10 Warnings Exact identifier application number: M017 De La Cruz Camphor CAMPHOR DLC Laboratories, Inc. 62359237-de2d-4497-bfd6-36991cfc8acf 2024-10-10 Warnings Exact identifier application number: M017 Anti Itch DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Meijer Distribution Inc 4f536a86-6419-4ab0-a7e8-5c37943823e2 2024-10-09 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