Home NDC 0280-0049-01 AleveX
Product NDC 0280-0049
Requested package NDC 0280-0049-01
11-digit product format 002800049
Labeler code 0280
Product ID 0280-0049_45261ca8-875e-7830-e063-6294a90ab33a
Type HUMAN OTC DRUG
Nonproprietary name camphor and menthol
Dosage form SPRAY
Route TOPICAL
Labeler Bayer HealthCare LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-04-01
Substance CAMPHOR (SYNTHETIC); MENTHOL
Active strength 5.5; 16 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 CAMPHOR (SYNTHETIC) 5.5 mg/g MENTHOL 16 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5TJD82A1ET Internal UNII lookup 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 0280-0049-01 AleveX 91 g in 1 CAN SPRAY 91 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0049 ALEVEX (CAMPHOR AND MENTHOL) SPRAY [BAYER HEALTHCARE LLC] 4 Current NDC, Legacy NDC, 1 package rows 20241208_bafd199a-e198-d5d1-e053-2995a90ad1cb.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 95 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GREEN GUARD Topical Pain Relief LIDOCAINE HCI Ultra Distributors Inc b6f0041c-47fc-0bcd-e053-2a95a90ab1f9 2025-04-07 Warnings Exact identifier application number: M017 CBD Clinic Pain Relief - Level 5 MENTHOL, CAMPHOR ABACUS HEALTH PRODUCTS, INC. f0ebc1c6-93fb-efd6-e053-2995a90a25bb 2025-04-07 Warnings Exact identifier application number: M017 CBD Clinic Pain Relief - Level 4 MENTHOL, CAMPHOR ABACUS HEALTH PRODUCTS, INC. f0e9ac7c-a840-2e05-e053-2a95a90a33f1 2025-04-07 Warnings Exact identifier application number: M017 CBDMEDIC Active Sport Pain Relief CAMPHOR AND MENTHOL ABACUS HEALTH PRODUCTS, INC. f0ec5f47-2f8e-0558-e053-2a95a90aa7ca 2025-04-07 Warnings Exact identifier application number: M017 Hot Cold Medicated Patches HOT COLD MEDICATED PATCHES Henan Enokon Medical Instrument Co., Ltd. 159266a8-94fa-e2ff-e063-6394a90a9a77 2025-04-02 Warnings Exact identifier application number: M017 Pain Relief Patch PAIN RELIEF PATCH Henan Enokon Medical Instrument Co., Ltd. 1592d29d-e275-a44d-e063-6294a90ab17d 2025-04-02 Warnings Exact identifier application number: M017 Jointflex CAMPHOR Strides Consumer LLC 766b73f2-67bd-4d5c-805c-1057b3981ebf 2025-04-02 Warnings Exact identifier application number: M017 Olu Pain Management LIDOCAINE AND CAMPHOR Asclemed USA, Inc. d4d556c1-b64b-4b8e-8e4b-4f40eda24250 2025-04-01 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate TROLAMINE SALICYLATE TELEBRANDS CORP 31ce185e-07b7-d837-e063-6394a90a1fb0 2025-04-01 Warnings Exact identifier application number: M017 CVS Pain Relief MENTHOL 10.5% CVS d0ea80ce-38b2-acde-e053-2995a90a47e5 2025-03-31 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE A2A Integrated Pharmaceuticals, LLC 31431866-6fb5-2acd-e063-6294a90ac520 2025-03-31 Warnings Exact identifier application number: M017 Citrus Cleansing Foot Soak and Body Soak CAMPHOR SANSAR, LLC f136616d-9f32-4e55-a495-b7466fd68526 2025-03-28 Warnings Exact identifier application number: M017 Zpol ULTRA MENTHOL, METHYL SALICYLATE Laboratorios Zepol S.A. 1a1433a6-8d04-96df-e063-6394a90a987b 2025-03-27 Warnings Exact identifier application number: M017 Muscle Recovery Foot Soak and Body Soak CAMPHOR SANSAR, LLC 1c347267-b653-41bf-9967-7feff17c38af 2025-03-27 Warnings Exact identifier application number: M017 Soothing Lavender Foot Soak and Body Soak CAMPHOR SANSAR, LLC ef26523a-b2f2-466e-89ad-f293cd64decb 2025-03-27 Warnings Exact identifier application number: M017 Achelon Lidocaine Patch LIDOCAINE PATCH 4% Achelon, Inc 31408e21-e58d-6db5-e063-6294a90aa4bc 2025-03-26 Warnings Exact identifier application number: M017 Achelon Lidocaine Patch LIDOCAINE PATCH 4% Achelon, Inc 3143bb72-2969-d66e-e063-6294a90a4604 2025-03-26 Warnings Exact identifier application number: M017 Parche Leon CAPSAICIN, CAMPHOR, MENTHOL Pharmadel LLC a8f266fa-6e43-559e-e053-2995a90a2c75 2025-03-26 Warnings Exact identifier application number: M017 Adellina Numbing Cream LIDOCAINE Guangzhou Haishi Biological Technology Co., Ltd. 314a83fe-8bdb-766f-e063-6294a90a61c6 2025-03-26 Warnings Exact identifier application number: M017 HealthWise Lidocaine Plus Menthol Patch LIDOCAINE AND MENTHOL Veridian Healthcare 312f15fe-9297-2dc2-e063-6294a90a6f4d 2025-03-25 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0280-0049-01 00280004901 91 g in 1 CAN (0280-0049-01) 91 g 2021-04-01 0000-00-00 No No Current