Home NDC 70983-007 Pain Release
Product NDC 70983-007
11-digit product format 709830007
Labeler code 70983
Product ID 70983-007_485126fc-a5e0-d844-e063-6394a90a2ada
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 12.18 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 12.18 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70983-007-09 Pain Release 100 mL in 1 BOTTLE, PLASTIC OIL 100 6 70983-007-09 Pain Release 1 in 1 BOX OIL 1 6 70983-007-10 Pain Release 1 in 1 BOX OIL 1 6 70983-007-10 Pain Release 200 mL in 1 BOTTLE, DROPPER OIL 200 6 70983-007-11 Pain Release 40 mL in 1 BOTTLE, PLASTIC OIL 40 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70983-007 PAIN RELEASE (MENTHOL) OIL [SAJE NATURAL BUSINESS INC.] 5 Current NDC, Legacy NDC, 5 package rows 20231006_92eec6e7-0367-43c6-bd28-1762390a7114.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 134 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dermachange Arthritis Relief TROLAMIN SALICYLATE Private Beauty Label and Wellness 12dbfa50-1b97-f988-e063-6394a90a662c 2024-03-04 Warnings Exact identifier application number: M017 Analgesic MENTHOL Safetec of America, Inc. b0f4010c-995f-40e1-aa40-92760e697a61 2024-03-02 Warnings Exact identifier application number: M017 Icy Hot Advanced Relief CAMPHOR AND MENTHOL Chattem, Inc. 9979ff36-415b-44e4-bb10-6bf682cd00f9 2024-03-01 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8% MENTHOL Amish Origins Management, LLC 5051b650-18a4-481e-a8d7-d41d4ae51efd 2024-02-29 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE TRIFECTA PHARMACEUTICALS USA LLC 2999fecb-cb15-4023-ade4-ab5822b094d5 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8 MENTHOL Amish Origins Management, LLC aaad56d5-6737-4edc-af0e-8e207695c0ec 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8% MENTHOL Amish Origins Management, LLC b120404f-5a07-4182-bb50-d943418622da 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Topical Analgesic Camphor 2% CAMPHOR (SYNTHETIC) Amish Origins Management, LLC 437491ca-60ff-4508-b408-f97e7152f638 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Topical Analgesic Camphor 2% CAMPHOR (SYNTHETIC) Amish Origins Management, LLC ffe15aed-ea90-4db8-aace-d691a81c05ae 2024-02-29 Warnings Exact identifier application number: M017 LidoPro Patch LIDOCAINE, MENTHOL, AND METHYL SALICYLATE Advanced Rx Pharmacy of Tennessee, LLC 128d0ba9-bc9d-af16-e063-6394a90af5ef 2024-02-29 Warnings Exact identifier application number: M017 Leader Roll-On Cooling Pain Relief Topical Analgesic MENTHOL, UNSPECIFIED FORM Cardinal Health, 110 dba LEADER e86cba40-6b10-454d-98b3-6b547456eaad 2024-02-29 Warnings Exact identifier application number: M017 Maximum Strength Scalp Itch Relief Anti-itch HYDROCORTISONE Rite Aid 55569563-fc38-4f97-8e74-9f96e3173384 2024-02-28 Warnings Exact identifier application number: M017 Walgreens Eczema Relief HYDROCORTISONE ACETATE Walgreen Co. 4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c 2024-02-28 Warnings Exact identifier application number: M017 meijer Cold Therapy Pain Relieving analgesic MENTHOL, UNSPECIFIED FORM Meijer Distribution, Inc fb163112-d84d-418d-a410-3214c0ee4b5a 2024-02-28 Warnings Exact identifier application number: M017 SunBurnt PLUS LIDOCAINE HYDROCHLORIDE Quest Products, LLC. 12128c75-015d-8a72-e063-6394a90ae00a 2024-02-23 Warnings Exact identifier application number: M017 Kroger Analgesic Analgesic LIDOCAINE HYDROCHLORIDE THE KROGER CO e6c5ead3-87d0-48ed-a4dc-86cf89ebb285 2024-02-22 Warnings Exact identifier application number: M017 Rugby Pain Relieving Analgesic MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE Bryant Ranch Prepack fcf48536-224e-4a3d-9124-770031823972 2024-02-22 Warnings Exact identifier application number: M017 meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesic MENTHOL, UNSPECIFIED FORM Meijer Distribution, Inc 8bc3956b-b82d-4ed3-8bc3-db0078466bbc 2024-02-22 Warnings Exact identifier application number: M017 Promescent Delay Wipes BENZOCAINE Absorption f0a5b6be-acc5-473c-9054-b9534e769db1 2024-02-20 Warnings Exact identifier application number: M017 Ralli Rapid Pain Relief MENTHOL Troy Manufacturing, Inc. 721658dc-3b1d-43ff-9032-e96851633cf9 2024-02-19 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70983-007-09 70983000709 1 BOTTLE, PLASTIC in 1 BOX (70983-007-09) / 100 mL in 1 BOTTLE, PLASTIC 2020-06-29 0000-00-00 No No Current 70983-007-10 70983000710 1 BOTTLE, DROPPER in 1 BOX (70983-007-10) / 200 mL in 1 BOTTLE, DROPPER 2016-10-16 0000-00-00 No No Current 70983-007-11 70983000711 40 mL in 1 BOTTLE, PLASTIC (70983-007-11) 40 ml 2016-10-16 0000-00-00 No No Current