Home NDC 83570-443 OWELL NATURALS Deep Penetrating Pain Relief
Product NDC 83570-443
11-digit product format 835700443
Labeler code 83570
Product ID 83570-443_0dba3e8a-1315-7ab3-e063-6394a90a8a6a
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form OINTMENT
Route TOPICAL
Labeler OWELL NATURALS BRAND, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-08
Substance MENTHOL
Active strength 76.6 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 OWELL NATURALS Deep Penetrating Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 76.6 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 2672826 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 83570-443-02 OWELL NATURALS Deep Penetrating Pain Relief 60 mL in 1 JAR OINTMENT 60 1 83570-443-03 OWELL NATURALS Deep Penetrating Pain Relief 103.5 mL in 1 JAR OINTMENT 103.5 1 83570-443-07 OWELL NATURALS Deep Penetrating Pain Relief 207 mL in 1 JAR OINTMENT 207 1 83570-443-14 OWELL NATURALS Deep Penetrating Pain Relief 414 mL in 1 JAR OINTMENT 414 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83570-443 OWELL NATURALS DEEP PENETRATING PAIN RELIEF (MENTHOL) OINTMENT [OWELL NATURALS BRAND, LLC] 1 Current NDC, 4 package rows 20240108_b36eb017-ed8d-476e-994b-22b275e00543.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 48 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 83570-443-02 83570044302 60 mL in 1 JAR (83570-443-02) 60 ml 2024-01-08 No No Current 83570-443-03 83570044303 103.5 mL in 1 JAR (83570-443-03) 103.5 ml 2024-01-08 No No Current 83570-443-07 83570044307 207 mL in 1 JAR (83570-443-07) 207 ml 2024-01-08 No No Current 83570-443-14 83570044314 414 mL in 1 JAR (83570-443-14) 414 ml 2024-01-08 No No Current