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 139 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dendracin Neurodendraxcin METHYL SALICYLATE, MENTHOL AND CAPSAICIN Proficient Rx LP 7e765fc1-74c6-4af3-a9cf-05b57011d7d8 2024-01-01 Warnings Exact identifier application number: M017 CeraVe Developed with Dermatologists Itch Relief Moisturizing PRAMOXINE HYDROCHLORIDE L'Oreal USA Products Inc c6a0880e-fc16-46e9-8314-c56c9d15bf31 2023-12-31 Warnings Exact identifier application number: M017 CeraVe Developed with Dermatologists Anti Itch HYDROCORTISONE L'Oreal USA Products Inc. 8d65e945-2557-486f-9279-ecbaa08f31c4 2023-12-31 Warnings Exact identifier application number: M017 Nighttime Sleep-Aid Non-Habit Forming DIPHENHYDRAMINE HCI AptaPharma Inc. ed0ba7aa-e794-43da-b576-6b9945bf7477 2023-12-30 Warnings Exact identifier application number: M017 Sting-Kill BENZOCAINE AND MENTHOL RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH b8bd9280-f20a-4b2a-aef7-a0ba7b3b8701 2023-12-29 Warnings Exact identifier application number: M017 Maybelline New York Baby Lips Dr Rescue Medicated Balm MENTHOL L'Oreal USA Products Inc 2f7b8221-66f6-4aed-8359-318cfc656a72 2023-12-28 Warnings Exact identifier application number: M017 Equate Cortisone HYDROCORTISONE 1% Walmart Inc 027fae33-93a0-a61f-e063-6294a90a990f 2023-12-27 Warnings Exact identifier application number: M017 Walgreens Cool n Heat Lidocaine LIDOCAINE HCL 4% Walgreens Co 0681c6c5-5a8b-ea9e-e063-6394a90a83bc 2023-12-27 Warnings Exact identifier application number: M017 EXTRA STRENGTH WAL-DRYL ITCH RELIEF DIPHENHYDRAMINE, ZINC ACETATE WALGREEN CO 681cf1af-2cc3-4e6d-b76f-f00731ea3e12 2023-12-27 Warnings Exact identifier application number: M017 XRay Pain Relief MENTHOL, (PLUS)-, CAMPHOR, (-)-, AND METHYL SALICYLATE Genomma Lab USA 5244ddee-fd9e-4df3-8fb3-b16aa321a316 2023-12-27 Warnings Exact identifier application number: M017 Camphor Spirit CAMPHOR 10% Pharma Nobis, LLC e42fbe63-b01c-4f85-e053-2a95a90a5143 2023-12-26 Warnings Exact identifier application number: M017 Equate Calaspray PRAMOXINE HCL 1%, ZINC ACETATE 0.1% Walmart Inc 027ed5ab-05ec-569f-e063-6394a90abbc3 2023-12-26 Warnings Exact identifier application number: M017 EXTERNAL ANALGESIC CAMPHOR, CAPSICUM, MENTHOL Hmong 21 3b6155a5-51aa-2780-e054-00144ff8d46c 2023-12-26 Warnings Exact identifier application number: M017 LEADER Camphor Spirit CAMPHOR (NATURAL) Cardinal Health, 110 dba Leader 7d3b0b28-5190-0622-e053-2991aa0af561 2023-12-22 Warnings Exact identifier application number: M017 Antiseptic Instant Pain Relief CAMPHOR 10.8% AND PHENOL 4.7% Pharma Nobis, LLC e42f484d-a642-3489-e053-2a95a90a4254 2023-12-22 Warnings Exact identifier application number: M017 Itch Relief Gel ITCH RELIEF GEL Pharma Nobis, LLC e42f484d-a641-3489-e053-2a95a90a4254 2023-12-22 Warnings Exact identifier application number: M017 Witch Hazel WITCH HAZEL Pharma Nobis, LLC e42f484d-a644-3489-e053-2a95a90a4254 2023-12-22 Warnings Exact identifier application number: M017 Dermoplast Pain relieving BENZOCAINE, MENTHOL Advantice Health dad00c95-4e11-3eec-e053-2a95a90a7a18 2023-12-21 Warnings Exact identifier application number: M017 equate Maximum Strength Pain Relieving 4% Lidocaine with Lavender Essential Oil Topical analgesic LIDOCAINE HYDROCHLORIDE Wal-Mart Stores, Inc. bf954949-a7b7-44ba-8565-f1d5c0a6c0d1 2023-12-21 Warnings Exact identifier application number: M017 Bactine Max Bandage LIDOCAINE WellSpring Pharmaceutical Corporation 465dc46e-6435-4569-9516-f648d0fe0f09 2023-12-21 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