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 131 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eagle Brand Medicated Roll On MENTHOL, METHYL SALICYLATE Borden Company (Private) Limited 1bc2f688-d0c4-690e-e063-6294a90abc38 2024-06-25 Warnings Exact identifier application number: M017 Eagle Brand Medicated Oil MENTHOL, METHYL SALICYLATE Borden Company (Private) Limited 1b9fdac0-9fb0-e669-e063-6394a90aece9 2024-06-24 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN Asclemed USA, Inc. 97d506bd-3215-4e2e-9914-af1c174dd4ab 2024-06-20 Warnings Exact identifier application number: M017 ABREVA Rapid Pain Relief GLYCERIN, LIDOCAINE Haleon US Holdings LLC 65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d 2024-06-20 Warnings Exact identifier application number: M017 Frankie Avalons ZERO PAIN Roll-On Pain Reliever CAPSAICIN WHY ENTERPRISES LLC e32acb5f-5bc3-4228-b037-6315d080f556 2024-06-17 Warnings Exact identifier application number: M017 PUREGEN LABS Pain Relief 4 Lidocaine LIDOCAINE Advanced Rx LLC 9dff40d8-8d7e-4629-bea5-987f5e68477d 2024-06-11 Warnings Exact identifier application number: M017 SMOOTH GATOR Head-Ezz Analgesic MENTHOL Smooth Gator LLC 02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd 2024-06-10 Warnings Exact identifier application number: M017 FIRST AID BURN LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE Epic Medical Supply Corp bd1b1873-e900-45eb-96a0-28f782b5a7cd 2024-06-04 Warnings Exact identifier application number: M017 Hydrocortisone 1% HYDROCORTISONE Chain Drug Marketing Association Inc. 1c834ba0-86b6-8e61-e063-6394a90a192d 2024-06-04 Warnings Exact identifier application number: M017 HealthWise Feminine Anti-itch Cream BENZOCAINE, RESORCINOL Veridian Healthcare 19fe7c3b-58e2-6c16-e063-6394a90a612a 2024-06-03 Warnings Exact identifier application number: M017 THE SOLUTION NUMBING LIDOCAINE HYDROCHLORIDE SCALP TECH INC 184be4cc-b0b9-7882-e063-6394a90a8e7e 2024-05-25 Warnings Exact identifier application number: M017 Methyl Salicylate 25 Percent METHYL SALICYLATE Alexso, Inc d8b8b0ba-69e9-4965-bf9b-6db21db69b34 2024-05-23 Warnings Exact identifier application number: M017 Meijer Medicated Chest Rub CAMPHOR, MENTHOL, EUCALYPTUS OIL Meijer Distribution 07ecc6a7-bbe3-35cf-e063-6394a90a2180 2024-05-22 Warnings Exact identifier application number: M017 TheraCare Hydrocortisone Cream HYDROCORTISONE Veridian Healthcare 01cb7b47-2c3c-707d-e063-6294a90a5d97 2024-05-21 Warnings Exact identifier application number: M017 TheraCare 4% Lidocaine Cream LIDOCAINE HYDROCHLORIDE Veridian Healthcare c808aa05-9d49-cc9f-e053-2a95a90a50f3 2024-05-21 Warnings Exact identifier application number: M017 TheraCare 4% Lidocaine and 1% Menthol Cream MENTHOL AND LIDOCAINE Veridian Healthcare c80ba251-91a5-0858-e053-2995a90a9cff 2024-05-21 Warnings Exact identifier application number: M017 HealthWise Menthol Roll-On MENTHOL Veridian Healthcare 102d57a5-6449-f825-e063-6294a90a8844 2024-05-21 Warnings Exact identifier application number: M017 SAFLY Burn LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 3aca2568-d10f-4b14-861b-6c741c106829 2024-05-17 Warnings Exact identifier application number: M017 HealthWise Menthol 4% Roll-On MENTHOL Veridian Healthcare 1894ef00-ba05-0e02-e063-6394a90ab982 2024-05-16 Warnings Exact identifier application number: M017 Leader Poison Ivy Wash PRAMOXINE HYDROCHLORIDE LOTION Cardinal Health, 110 dba Leader 81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c 2024-05-13 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 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