Home NDC 70983-023 Extra Strength
Product NDC 70983-023
11-digit product format 709830023
Labeler code 70983
Product ID 70983-023_41ee90e0-d371-d1e7-e063-6394a90a42e3
Type HUMAN OTC DRUG
Nonproprietary name Menthol and Methyl Salicylate
Dosage form OIL
Route TOPICAL
Labeler Saje Natural Business Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-05-13
Substance MENTHOL; METHYL SALICYLATE
Active strength 94.41; 123.74 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Extra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 94.41 mg/mL METHYL SALICYLATE 123.74 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup LAV5U5022Y 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 70983-023-01 Extra Strength 1 in 1 BOX OIL 1 8 70983-023-01 Extra Strength 45 mL in 1 BOTTLE, WITH APPLICATOR OIL 45 8 70983-023-02 Extra Strength 20 mL in 1 BOTTLE, WITH APPLICATOR OIL 20 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70983-023 EXTRA STRENGTH (MENTHOL AND METHYL SALICYLATE) OIL [SAJE NATURAL BUSINESS INC.] 7 Current NDC, Legacy NDC, 3 package rows 20231006_87d872b3-3231-d0f2-e053-2995a90a9d98.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 48 of 151 · 3,020 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 70983-023-01 70983002301 1 BOTTLE, WITH APPLICATOR in 1 BOX (70983-023-01) / 45 mL in 1 BOTTLE, WITH APPLICATOR 2019-05-13 0000-00-00 No No Current 70983-023-02 70983002302 20 mL in 1 BOTTLE, WITH APPLICATOR (70983-023-02) 20 ml 2022-10-31 0000-00-00 No No Current