Home NDC 0280-0050-01 AleveX
Product NDC 0280-0050
Requested package NDC 0280-0050-01
11-digit product format 002800050
Labeler code 0280
Product ID 0280-0050_45261b62-142c-8c69-e063-6294a90a011f
Type HUMAN OTC DRUG
Nonproprietary name camphor and menthol
Dosage form LOTION
Route TOPICAL
Labeler Bayer HealthCare LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-04-01
Substance MENTHOL; CAMPHOR (SYNTHETIC)
Active strength 16; 5.5 mg/g; 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 AleveX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 16 mg/g CAMPHOR (SYNTHETIC) 5.5 mg/g
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 5TJD82A1ET 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 0280-0050-01 AleveX 1 in 1 CARTON LOTION 1 5 0280-0050-01 AleveX 72 g in 1 BOTTLE, WITH APPLICATOR LOTION 72 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0050 ALEVEX (CAMPHOR AND MENTHOL) LOTION [BAYER HEALTHCARE LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241208_bc66bc1b-c0d5-2481-e053-2a95a90a75de.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 77 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 0280-0050-01 00280005001 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0280-0050-01) / 72 g in 1 BOTTLE, WITH APPLICATOR 2021-04-01 0000-00-00 No No Current