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 149 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SCLERA CARE Topical Anesthetic Gel LIDOCAINE HYDROCHLORIDE ScleraCare, LLC 488ace02-fc0b-4d13-ab89-0e1640e915e5 2023-11-05 Warnings Exact identifier application number: M017 IRELIEV ROLL ON COOL PAIN RELIEF MENTHOL Excel Health, Inc dab94995-7393-4d9c-b295-72611a90919b 2023-11-05 Warnings Exact identifier application number: M017 URIFLEX Fast Acting Analgesic Pain Relief MENTHOL Rejuvica LLC fb78f705-b838-461d-b42c-8c98d3ca5d09 2023-11-05 Warnings Exact identifier application number: M017 365 Medicated Lip Balm MEDICATED LIP BALM Whole Foods Market, Inc. 48309a7d-d2da-483c-8bf8-f59d9ad0bb73 2023-11-03 Warnings Exact identifier application number: M017 COOL BREEZE Pain Relief MENTHOL COOL BREEZE US LLC 14dcf4ee-6778-49d4-8601-9205737432ea 2023-11-01 Warnings Exact identifier application number: M017 Lidozen LIDOCAINE HYDROCHLORIDE, MENTHOL Proficient Rx LP 1ebb45e5-4541-4c95-abe1-661ef763a610 2023-11-01 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Cream LIDOCAINE 4% Walgreens ce1b55ed-f5c5-ea8b-e053-2a95a90acd40 2023-10-31 Warnings Exact identifier application number: M017 Walgreens pain relieving LIDOCAINE 4% Walgreens ce2b9e57-749d-715c-e053-2995a90aaf8d 2023-10-31 Warnings Exact identifier application number: M017 Walgreens Cool n heat LIDOCAINE 4% MENTHOL 1% Walgreens ce168ab7-ec4a-daea-e053-2995a90af829 2023-10-31 Warnings Exact identifier application number: M017 Methyl Salicylate 40 Percent METHYL SALICYLATE Alexso, Inc 53407aab-094c-4393-a2b9-54fd85321e3e 2023-10-31 Warnings Exact identifier application number: M017 Hydrocortisone Acetate HYDROCORTISONE ACETATE Bentlin Products LLC 4346351c-8e11-46ae-b428-98d17f55beb9 2023-10-30 Warnings Exact identifier application number: M017 Biofreeze Roll-On MENTHOL A-S Medication Solutions 814b37ea-5441-4cec-8794-71ca01d849ae 2023-10-30 Warnings Exact identifier application number: M017 Dr. Sheffield Hydrocortisone Anti itch HYDROCORTISONE Sheffield Pharmaceuticals LLC 71c9f2f4-2188-45eb-b55e-3856ac78070b 2023-10-30 Warnings Exact identifier application number: M017 Family Wellness BENZOCAINE, RESORCINOL Zhejiang Jingwei Pharmaceutic Al Co., Ltd. df540eb8-6773-4647-9cc2-c3fd14d7355e 2023-10-27 Warnings Exact identifier application number: M017 Family Wellness HYDROCORTISONE 1% FRONT PHARMACEUTICAL PLC ea26265d-f24e-458e-8bf0-287b2d49f4f4 2023-10-27 Warnings Exact identifier application number: M017 Joint Formula 88 MAX PLUS CAMPHOR Sarati International, Inc. f5d78335-b78d-4909-a88b-9daa3c18ba15 2023-10-27 Warnings Exact identifier application number: M017 OsmoFlex MENTHOL Sarati International, Inc. 479147c0-4cf4-4d7a-8b8e-1a0de49ed73e 2023-10-27 Warnings Exact identifier application number: M017 Thera plus Anti-itch with aloe Hydrocortisone HYDROCORTISONE Fourstar Group USA, Inc. c69d0670-a65b-1680-e053-2995a90a2ee5 2023-10-26 Warnings Exact identifier application number: M017 Family Wellness DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE FRONT PHARMACEUTICAL PLC fde2069b-344e-46da-bb95-c5113e0f35d6 2023-10-26 Warnings Exact identifier application number: M017 MAXIMUM STRENGTH HEMORRHOIDAL RELIEF LIDOCAINE CVS PHARMACY, INC b61424bf-3b23-420b-a7bc-256ddb96aa22 2023-10-25 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