Home NDC 79643-004 Methyl Salicylate
Product NDC 79643-004
11-digit product format 796430004
Labeler code 79643
Product ID 79643-004_5d6c885d-8d55-738a-e063-6394a90a074e
Type HUMAN OTC DRUG
Nonproprietary name Methyl Salicylate
Dosage form CREAM
Route TOPICAL
Labeler PHARMACURE LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-01
Substance METHYL SALICYLATE
Active strength 250 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 Methyl Salicylate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYL SALICYLATE 250 mg/g
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79643-004-01 Methyl Salicylate 100 g in 1 TUBE CREAM 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79643-004 METHYL SALICYLATE CREAM [PHARMACURE LLC] 2 Current NDC, 1 package rows 20240524_f119a1bd-095f-41f5-86d5-c0ee4f19fd2c.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 150 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DIRT Pain Relieving Gel MENTHOL PURIVITAE, LLC e43e2cbd-d114-4b11-8baf-7a775881cd97 2023-11-06 Warnings Exact identifier application number: M017 Celadrin Joint and Muscle Pain Relieving MENTHOL Factors Group of Nutritional Products 6396e4b6-2130-433b-bdb3-97c76dbe685c 2023-11-06 Warnings Exact identifier application number: M017 Atomic Balm METHYL SALICYLATE, CAPSAICIN The Hygenic Company, LLC d10028f3-ae6a-7b01-e053-2995a90a5a84 2023-11-05 Warnings Exact identifier application number: M017 HEMPCIN Advanced Topical Pain Relief Cream MENTHOL Pedicis Research, LLC 97f5e300-b780-4694-a681-60d5e0cfad65 2023-11-05 Warnings Exact identifier application number: M017 Point Relief cold Spot Pain Relieving roll-on MENTHOL Fabrication Enterprises 3f1db0ad-aaa8-4e14-9349-45057e0fb4a6 2023-11-05 Warnings Exact identifier application number: M017 LidoStat LIDOCAINE HCL Clinical Therapeutic Solutions 1825885b-9141-4515-bb69-a1c4a39fb10d 2023-11-05 Warnings Exact identifier application number: M017 Point Relief Cold Spot Pain Relieving MENTHOL Fabrication Enterprises 391af69f-74aa-48cf-bc96-75e5c4e0e445 2023-11-05 Warnings Exact identifier application number: M017 FEEL GOOD LABS NATURAL PAIN MENTHOL The Feel Good Lab 778b62a1-ebd3-4a30-8f76-6d6773b698c5 2023-11-05 Warnings Exact identifier application number: M017 FEEL GOOD LABS SPORT RECOVERY MENTHOL The Feel Good Lab 103c5e33-42fb-41ac-957e-bb46d85e204c 2023-11-05 Warnings Exact identifier application number: M017 INSTA RELIEF DM LIDOCAINE HYDROCHLORIDE, MENTHOL DM LAB CORP 6ef66fb9-9f49-409d-9503-175c7555ee9e 2023-11-05 Warnings Exact identifier application number: M017 DR. MIKES Ponos Pain Relief Cream Roll-On HISTAMINE DIHYDROCHLORIDE, MENTHOL Dr. Mike's Vitamins, LLC fcc45464-f1fe-4244-95a7-9b4288b0ce45 2023-11-05 Warnings Exact identifier application number: M017 AcuPlus Pain Relief MENTHOL Innovations for Wellness, LLC 7f222a4f-85a8-4f3d-aa97-5c695d4da37f 2023-11-05 Warnings Exact identifier application number: M017 Ana Cool Rapid Soothing Cooling Formula HYDROCORTISONE Ana-Cool, LLC 64b80cc2-e2d8-4535-aaf8-c031f4159cd1 2023-11-05 Warnings Exact identifier application number: M017 FEEL GOOD LABS SPORT RECOVERY MENTHOL THE FEEL GOOD LAB, LLC 19b08cbf-5f43-4f07-8f4d-8cddb1492ab8 2023-11-05 Warnings Exact identifier application number: M017 PlayMakar Roll On Cool Pain Relief MENTHOL PlayMakar Inc. a12c16e7-561f-45a7-93c6-34d693ffdc7c 2023-11-05 Warnings Exact identifier application number: M017 AcuPlus Advanced Therapy for Pain and Recovery MENTHOL INNOVATIONS FOR WELLNESS, LLC 840cfd15-4ea1-49bf-8c4f-86c12461d860 2023-11-05 Warnings Exact identifier application number: M017 SCLERA CARE Topical Anesthetic Gel LIDOCAINE HYDROCHLORIDE ScleraCare, LLC 488ace02-fc0b-4d13-ab89-0e1640e915e5 2023-11-05 Warnings Exact identifier application number: M017 IRELIEV ROLL ON COOL PAIN RELIEF MENTHOL Excel Health, Inc dab94995-7393-4d9c-b295-72611a90919b 2023-11-05 Warnings Exact identifier application number: M017 URIFLEX Fast Acting Analgesic Pain Relief MENTHOL Rejuvica LLC fb78f705-b838-461d-b42c-8c98d3ca5d09 2023-11-05 Warnings Exact identifier application number: M017 365 Medicated Lip Balm MEDICATED LIP BALM Whole Foods Market, Inc. 48309a7d-d2da-483c-8bf8-f59d9ad0bb73 2023-11-03 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 79643-004-01 79643000401 100 g in 1 TUBE (79643-004-01) 100 g 2024-05-01 No No Current