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 112 of 153 · 3,057 matching rows.
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