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 40 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Itch Relief Gel DIPHENHYDRAMINE HCL Walgreens 487060a7-dff3-4840-b967-ca919f8d0a29 2026-01-15 Warnings Exact identifier application number: M017 Walgreen Itch Relief Gel DIPHENHYDRAMINE HYDROCHLORIDE Walgreens 5aca3297-406f-4165-9895-c58ccffb374f 2026-01-15 Warnings Exact identifier application number: M017 Pain Relieving Patch LIDOCAINE FlexiGo Inc. 4868af2a-c4be-9c68-e063-6394a90a565b 2026-01-15 Warnings Exact identifier application number: M017 Helocaine Cold Sore Fever Blister Treatment TETRACAINE, MINERAL Pagari Life Science Corp. 1b2eae09-5de0-9219-e063-6294a90af046 2026-01-15 Warnings Exact identifier application number: M017 Careland Lidocaine 4 Pain Relieving Gel-Patches LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. a6ca8382-7ce5-4df9-912e-8a0ac0423116 2026-01-15 Warnings Exact identifier application number: M017 Neuropathy Cream MENTHOL CREAM Owell Naturals Brand, LLC 48739205-627b-41d0-e063-6394a90a3462 2026-01-15 Warnings Exact identifier application number: M017 BLT 1 BENZOCAINE CENTURA PHARMACEUTICALS INC 3eea2171-850b-4045-e054-00144ff8d46c 2026-01-15 Warnings Exact identifier application number: M017 Icy Hot Lidocaine Dry LIDOCAINE, MENTHOL Chattem, Inc. d500a74e-ab93-4919-8665-a89e9d4cad28 2026-01-15 Warnings Exact identifier application number: M017 Cortizone 10 Bug Bite Relief 1% HYDROCORTISONE Chattem, Inc. b21b6c04-8246-4567-98cf-64e8c588e79c 2026-01-15 Warnings Exact identifier application number: M017 Gold Bond Intensive Relief Anti-Itch PRAMOXINE HYDROCHLORIDE, MENTHOL Chattem, Inc. e5a3f8d4-b3d8-4b88-b9a9-833406d3e6f8 2026-01-14 Warnings Exact identifier application number: M017 Cortizone-10 Soothing Aloe Creme HYDROCORTISONE Chattem, Inc. 1a841bf0-9d7b-4566-b442-aa9bcc827846 2026-01-14 Warnings Exact identifier application number: M017 Cortisone 10 Sensitive Skin Creme HYDROCORTISONE Chattem, Inc. b139917c-00bb-4cb3-995d-a6d2f2c295c6 2026-01-14 Warnings Exact identifier application number: M017 Cortizone 10 for Psoriasis HYDROCORTIZONE Chattem, Inc. fad9eedb-95e1-4e1a-91e5-0bfd077e0cf5 2026-01-14 Warnings Exact identifier application number: M017 Pain Relief Roll On TOPICAL ANALGESIC Eagle Labs Inc 2380a400-062a-4a8d-a594-a2e097219044 2026-01-14 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE 4% AvKARE 70aace2f-47b4-e961-e053-2991aa0a6367 2026-01-14 Warnings Exact identifier application number: M017 JUST CBD - ULTRA RELIEF MENTHOL, CAMPHOR Just Brands LLC 485f355a-4458-67b6-e063-6394a90ab2a0 2026-01-14 Warnings Exact identifier application number: M017 Relief Pain Relieving Cream MENTHOL Corganics, LP 85814fff-35f8-447f-b669-87eaf55e9859 2026-01-14 Warnings Exact identifier application number: M017 Mentholatum Soothing Vapor Rub Cherry CAMPHOR, EUCALYPTUS OIL, MENTHOL The Mentholatum Company 486269c9-af3a-7856-e063-6294a90a378c 2026-01-14 Warnings Exact identifier application number: M017 Mentholatum Vapor Max CAMPHOR, EUCALYPTUS OIL, MENTHOL The Mentholatum Company 4863606f-f7c8-b4a4-e063-6294a90a1138 2026-01-14 Warnings Exact identifier application number: M017 Hydrocortisone Cream Intensive Healing HYDROCORTISONE CREAM Walgreens 8a3f486c-1353-466d-9ea7-c14559b53bf3 2026-01-14 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