Home NDC 70983-002 Fortify
Product NDC 70983-002
11-digit product format 709830002
Labeler code 70983
Product ID 70983-002_4850561f-988a-f1a7-e063-6394a90a982b
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form OIL
Route TOPICAL
Labeler Saje Natural Business Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-10-16
Substance MENTHOL
Active strength 24 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 Fortify
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 24 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 70983-002 FORTIFY (MENTHOL) OIL [SAJE NATURAL BUSINESS INC.] 4 Current NDC, Legacy NDC, 6 package rows 20231006_0320a305-99d1-4909-94cc-cd6509ecb948.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 98 of 178 · 3,551 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70983-002-03 70983000203 1 BOTTLE, DROPPER in 1 BOX (70983-002-03) / 30 mL in 1 BOTTLE, DROPPER 2016-10-16 0000-00-00 No No Current 70983-002-04 70983000204 1 BOTTLE, DROPPER in 1 BOX (70983-002-04) / 10 mL in 1 BOTTLE, DROPPER 2016-10-16 0000-00-00 No No Current 70983-002-05 70983000205 1 BOTTLE, DROPPER in 1 BOX (70983-002-05) / 6 mL in 1 BOTTLE, DROPPER 2016-10-16 0000-00-00 No No Current