Home NDC 83570-007 OWELL NATURALS ARTHRITIS MAXIMUM STRENGTH
Product NDC 83570-007
11-digit product format 835700007
Labeler code 83570
Product ID 83570-007_57984bc2-bf1e-c423-e063-6394a90a06ae
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form CREAM
Route TOPICAL
Labeler OWELL NATURAL 8 LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-27
Substance MENTHOL
Active strength 80 mg/g
NDC exclude flag No
Listing certified through 2027-12-31
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 OWELL NATURALS ARTHRITIS MAXIMUM STRENGTH
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 80 mg/g
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 727161 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 111 of 152 · 3,029 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83570-007-02 83570000702 60 g in 1 BOTTLE (83570-007-02) 60 g 2026-07-27 No No Current