Home NDC 70983-006 Pain Release
Product NDC 70983-006
11-digit product format 709830006
Labeler code 70983
Product ID 70983-006_48511d13-43c4-cc16-e063-6394a90a8458
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form OIL
Route TOPICAL
Labeler Saje Natural Business Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-10-16
Substance MENTHOL
Active strength 17.62 mg/mL
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 Pain Release
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 17.62 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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70983-006 PAIN RELEASE (MENTHOL) OIL [SAJE NATURAL BUSINESS INC.] 4 Current NDC, Legacy NDC, 6 package rows 20231006_3df0e56a-7651-42dc-8ed8-f68836a63c61.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 112 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join QC Cool and Heat Roll-On MENTHOL 16% Chain Drug Marketing Association Inc d35e9dfa-8a28-fdb3-e053-2995a90abc52 2024-12-15 Warnings Exact identifier application number: M017 Meijer Cold and Hot Pain Relieving MENTHOL 16% Meijer bec62df3-06c9-a115-e053-2995a90a4267 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief MENTHOL 16% Tommie Copper, Inc. b4dfa5fa-2d61-db1e-e053-2a95a90a7ac8 2024-12-15 Warnings Exact identifier application number: M017 Pain Relief Liquid Roller CAMPHOR 3.5%, MENTHOL 3.5% Tommie Copper, Inc. c9f0447e-de43-16a5-e053-2995a90a05c1 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief Maximum Strength TROLAMINE SALICYLATE 10% Tommie Copper, Inc. b622c14f-9bf3-0bbd-e053-2a95a90a2adc 2024-12-15 Warnings Exact identifier application number: M017 Copperlife Pain Relief TROLAMINE SALICYLATE 10% Tommie Copper, Inc. c94d00f9-42ce-1d43-e053-2a95a90a058d 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief Roller CAMPHOR 3.5%, MENTHOL 3.5% Tommie Copper, Inc. b6c3d6eb-b485-33b8-e053-2a95a90a41e1 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief Roller CAMPHOR 3.5%, MENTHOL 3.5% Tommie Copper, Inc. b4cd4fed-e8c8-db85-e053-2995a90a708b 2024-12-15 Warnings Exact identifier application number: M017 Copperlife Pain Relief Liquid MENTHOL 16% Tommie Copper, Inc. c93a0139-953b-5523-e053-2a95a90a0b2d 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief TROLAMINE SALICYLATE 10% Tommie Copper, Inc. ca011b03-a263-1908-e053-2995a90ad970 2024-12-15 Warnings Exact identifier application number: M017 Warrior Chiggerex Relief BENZOCAINE 10% Derma Care Research Labs, LLC dcf2f52b-2295-58e5-e053-2995a90a7fd8 2024-12-15 Warnings Exact identifier application number: M017 Capsaicin Cream CAPSAICIN Trifecta Pharmaceuticals USA LLC def8d341-06a7-0e9b-e053-2995a90a0ad6 2024-12-13 Warnings Exact identifier application number: M017 Mentholatum Original CAMPHOR, MENTHOL The Mentholatum Company 19e4b812-67c6-49fd-833a-b432100363f5 2024-12-13 Warnings Exact identifier application number: M017 Cold and Hot Medicated MENTHOL The Mentholatum Company 85bf425d-59d7-4462-ba46-292145460099 2024-12-13 Warnings Exact identifier application number: M017 Mentholatum Lidocaine Ice LIDOCAINE HCL, MENTHOL The Mentholatum Company 4d74cbab-31cd-4579-9360-6852ee215b5e 2024-12-13 Warnings Exact identifier application number: M017 Mentholatum Deep Heating Rub Extra Strength MENTHOL, METHYL SALICYLATE The Mentholatum Company f5684158-0d83-4031-b493-5422ddc73e78 2024-12-13 Warnings Exact identifier application number: M017 Discount Drug Mart Anti-Itch CAMPHOR, MENTHOL Discount Drug Mart 87d379da-103a-c751-e053-2995a90a56de 2024-12-13 Warnings Exact identifier application number: M017 Audiologist Anti-itch HYDROCORTISONE OAKTREE PRODUCTS, INC. 853e078e-1e91-d55f-e053-2991aa0a6dcd 2024-12-13 Warnings Exact identifier application number: M017 CVS Anti itch HYDROCORTISONE CVS 884df604-711b-4a3d-e053-2995a90a3a04 2024-12-13 Warnings Exact identifier application number: M017 Dermoplast Pain Relieving BENZOCAINE AND LEVOMENTHOL Advantice Health, LLC 2347f0b8-d463-422d-8583-65624d9a1a91 2024-12-12 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70983-006-03 70983000603 1 BOTTLE, DROPPER in 1 BOX (70983-006-03) / 30 mL in 1 BOTTLE, DROPPER 2016-10-16 0000-00-00 No No Current 70983-006-04 70983000604 1 BOTTLE, DROPPER in 1 BOX (70983-006-04) / 10 mL in 1 BOTTLE, DROPPER 2016-10-16 0000-00-00 No No Current 70983-006-05 70983000605 1 BOTTLE, DROPPER in 1 BOX (70983-006-05) / 6 mL in 1 BOTTLE, DROPPER 2016-10-16 0000-00-00 No No Current