Home NDC 69204-027 Extra Strength
Product NDC 69204-027
11-digit product format 692040027
Labeler code 69204
Product ID 69204-027_297f0ddf-6d38-b182-e063-6394a90a6570
Type HUMAN OTC DRUG
Nonproprietary name Menthol and Methyl Salicylate
Dosage form OIL
Route TOPICAL
Labeler NATURES FORMULAE HEALTH PRODUCTS LTD.
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 69204-027-01 Extra Strength 1 in 1 BOX OIL 1 2 69204-027-01 Extra Strength 45 mL in 1 BOTTLE, WITH APPLICATOR OIL 45 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69204-027 EXTRA STRENGTH (MENTHOL AND METHYL SALICYLATE) OIL [NATURES FORMULAE HEALTH PRODUCTS LTD.] 2 Current NDC, Legacy NDC, 2 package rows 20241220_d919b50a-5de2-1830-e053-2a95a90ab88d.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 Marketing start Marketing end Sample Exclude flag Status 69204-027-01 69204002701 1 BOTTLE, WITH APPLICATOR in 1 BOX (69204-027-01) / 45 mL in 1 BOTTLE, WITH APPLICATOR 2019-05-13 0000-00-00 No No Current