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 19 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Biofreeze Menthol MENTHOL, UNSPECIFIED FORM Reckitt Benckiser LLC 3f2b1f48-2d78-4985-a046-9f72de5e1a9b 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze MENTHOL Reckitt Benckiser LLC 10a8face-47da-ebbe-e063-6294a90a42fe 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Foot Cream MENTHOL Reckitt Benckiser LLC 32450cbf-4ed4-402b-a30e-e08a17bba3fb 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze MENTHOL Reckitt Benckiser LLC a227213b-e89f-7144-e053-2a95a90a7e74 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze MENTHOL Reckitt Benckiser LLC 00bb462a-27d0-6f74-e063-6394a90a90ec 2026-05-13 Warnings Exact identifier application number: M017 BioFreeze Dry Stick MENTHOL Reckitt Benckiser LLC 26d62cd2-9209-8cca-e063-6394a90a2028 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Foot Pain Relief Set MENTHOL Reckitt Benckiser LLC 4a885eef-0364-4655-bccc-7158c76cc5b2 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Colorless Roll-On MENTHOL Reckitt Benckiser LLC a8d59d45-0e85-43d1-affd-bbe922c4acb1 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Colorless MENTHOL Reckitt Benckiser LLC 939dbbc3-71ec-4990-840e-7c9b8d430562 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Flexible Relief Strip MENTHOL Reckitt Benckiser LLC 6ec26bae-e395-49aa-969e-8c653d6f0b27 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Day and Overnight MENTHOL Reckitt Benckiser LLC fb5c8f89-a720-ad32-e053-6294a90a2abe 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Foam MENTHOL Reckitt Benckiser LLC 890191e8-99ad-489c-8f21-2592f3d31936 2026-05-13 Warnings Exact identifier application number: M017 Orajel Cold Sore Touch Free - Single Dose BENZALKONIUM CHLORIDE, BENZOCAINE Church & Dwight Co., Inc. ce40829e-941f-2548-e053-2995a90a1e0e 2026-05-13 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Patch LIDOCAINE GERI-CARE PHARMACEUTICAL CORP 51b7753b-8619-6ea9-e063-6294a90a4ea4 2026-05-13 Warnings Exact identifier application number: M017 DERMFREE Anti-itch Cream HYDROCORTISONE1% ANTI-ITCH CREAM Jiangxi Zhongletang Pharmaceuticals Co.,Ltd. 519c319a-9c43-0e63-e063-6394a90ab869 2026-05-13 Warnings Exact identifier application number: M017 Valtrum TOPICAL ANALGESIC CAMPHOR, MENTHOL, METHYL SALICYLATE Laboratorios Quantium LLC f3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Professional Colorless MENTHOL, UNSPECIFIED FORM Reckitt Benckiser 4639201c-a67a-475f-8df6-3dc6225803ad 2026-05-12 Warnings Exact identifier application number: M017 Biofreeze Professional Colorless Roll-On MENTHOL, UNSPECIFIED FORM Reckitt Benckiser LLC bae9946a-4c68-4759-9fb3-0a61a7ad0eb7 2026-05-12 Warnings Exact identifier application number: M017 Instaflex Pain Relief Cream MENTHOL Healthy Directions, LLC 665b847a-9cfb-49fc-975b-81c97f936575 2026-05-12 Warnings Exact identifier application number: M017 Theracare Cold Therapy Pain Relief MENTHOL Veridian Healthcare 51a5a043-07b6-1c96-e063-6394a90aa926 2026-05-12 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