Home NDC 70983-003 Sweet Comfort
Product NDC 70983-003
11-digit product format 709830003
Labeler code 70983
Product ID 70983-003_48503e7b-ae58-b667-e063-6294a90a4561
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 24.56 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 Sweet Comfort
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 24.56 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 70983-003-04 Sweet Comfort 10 mL in 1 BOTTLE, DROPPER OIL 10 5 70983-003-04 Sweet Comfort 1 in 1 BOX OIL 1 5 70983-003-05 Sweet Comfort 6 mL in 1 BOTTLE, DROPPER OIL 6 5 70983-003-05 Sweet Comfort 1 in 1 BOX OIL 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70983-003 SWEET COMFORT (MENTHOL) OIL [SAJE NATURAL BUSINESS INC.] 4 Current NDC, Legacy NDC, 4 package rows 20231006_cf13cccd-723d-4d61-8a5e-b36281605cc7.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 74 of 180 · 3,583 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70983-003-04 70983000304 1 BOTTLE, DROPPER in 1 BOX (70983-003-04) / 10 mL in 1 BOTTLE, DROPPER 2016-10-16 0000-00-00 No No Current 70983-003-05 70983000305 1 BOTTLE, DROPPER in 1 BOX (70983-003-05) / 6 mL in 1 BOTTLE, DROPPER 2016-10-16 0000-00-00 No No Current