Home NDC 70983-004 Pain Release
Product NDC 70983-004
11-digit product format 709830004
Labeler code 70983
Product ID 70983-004_484f674c-ba73-e18f-e063-6394a90a896b
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form GRANULE
Route TOPICAL
Labeler Saje Natural Business Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-10-16
Substance MENTHOL
Active strength 1.6 mg/g
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 1.6 mg/g
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70983-004-05 Pain Release 300 g in 1 BOTTLE, PLASTIC GRANULE 300 5 70983-004-06 Pain Release 620 g in 1 BOTTLE, PLASTIC GRANULE 620 5 70983-004-07 Pain Release 1 in 1 PACKET GRANULE 1 5 70983-004-07 Pain Release 120 g in 1 POUCH GRANULE 120 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70983-004 PAIN RELEASE (MENTHOL) GRANULE [SAJE NATURAL BUSINESS INC.] 4 Current NDC, Legacy NDC, 4 package rows 20231006_1ac2ed54-194c-4de2-8e7f-6e74ca32aa40.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 116 of 152 · 3,029 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70983-004-05 70983000405 300 g in 1 BOTTLE, PLASTIC (70983-004-05) 300 g 2020-06-29 0000-00-00 No No Current 70983-004-06 70983000406 620 g in 1 BOTTLE, PLASTIC (70983-004-06) 620 g 2016-10-16 0000-00-00 No No Current 70983-004-07 70983000407 1 POUCH in 1 PACKET (70983-004-07) / 120 g in 1 POUCH 1 pouch 2016-10-16 0000-00-00 No No Current