Home NDC 0904-5694 Major Extra Strength Cold and Hot Pain Relief Therapy
Product NDC 0904-5694
11-digit product format 009045694
Labeler code 0904
Product ID 0904-5694_5f8d597b-7afa-1c26-e053-2991aa0a6bc1
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form PATCH
Route TOPICAL
Labeler Major Pharmaceuticals
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2013-06-30
Marketing end 0000-00-00
Substance MENTHOL
Active strength 750 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 0904-5694 D Discontinued by firm 2026-07-31 excluded package package 0904-5694 0904-5694-01 D Discontinued by firm 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rugby Muscle Rub Cream MUSCLE RUB CREAM Preferred Pharmaceuticals Inc. ea209a4e-acad-413b-8fb9-27e98130bcd6 2026-07-28 Warnings Exact identifier hydrocortisone HYDROCORTISONE Preferred Pharmaceuticals Inc. 12cd35e3-e707-4551-b778-bf615c1a8d32 2026-05-11 Warnings Exact identifier Arthritis Pain Relieving Cream MENTHOL, METHYL SALICYLATE International Nature Nutraceuticals, Inc. 2c9d070c-bf90-4482-8a6e-c7491cdd34c5 2025-12-27 Warnings Exact identifier New Terocin METHYL SALICYLATE, CAPSAICIN, AND MENTHOL Preferred Pharmaceuticals Inc. 186445d4-ef73-4d34-849d-4661a3eaa43a 2025-09-30 Warnings Exact identifier Terocin LIDOCAINE, MENTHOL Preferred Pharmaceuticals, Inc. 23843354-e242-4a8a-8818-897592d4d9a0 2025-09-30 Warnings Exact identifier Discount Drug Mart Regular Strength Itch Stopping DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Discount Drug Mart 8748c31d-8258-0357-e053-2a95a90a9c22 2019-04-24 Warnings Exact identifier Best Choice Itch Relief DIPHENHYDRAMINE HCL, ZINC ACETATE Valu Merchandisers 873591ef-16cb-ab90-e053-2991aa0a865d 2019-04-23 Warnings Exact identifier Fire Out BENZOCAINE AND MENTHOL Randob Ltd. 77ab634e-13d4-4f5f-87c8-73976e65a842 2019-04-12 Warnings Exact identifier Discount Drug Mart Anti-itch HYDROCORTISONE DISCOUNT DRUG MART, INC. 853eee29-6f57-59d4-e053-2991aa0aa611 2019-03-29 Warnings Exact identifier MEDICATED LIP BALM MENTHOL AND EUCALYPTUS Burt's Bees, Inc. 30da3cc5-6140-2dee-e054-00144ff8d46c 2018-12-21 Warnings Exact identifier Instaflex Pain Relief Cream MENTHOL Adaptive Health, LLC 911f5021-a851-444e-8c2a-2be4fa94e828 2018-12-21 Warnings Exact identifier Fast Freeze CAMPHOR (NATURAL), MENTHOL Natural Essentials Inc. 60c94da8-6c00-4544-a9a6-a3e87ebabd68 2018-10-18 Warnings Exact identifier Analgesic MENTHOL Safetec of America, Inc. a90266d4-1e71-4805-aeca-6f8ed45135bb 2018-10-01 Warnings Exact identifier COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEF MENTHOL NATURAL ESSENTIALS, INC. 9fcc79e6-8176-4ebc-8602-0649b02fab86 2018-09-27 Warnings Exact identifier Capsaicin Pain Relief CAPSAICIN Kareway Product, Inc. dce9db37-cd07-44d8-8881-f63a2191964f 2018-06-07 Warnings Exact identifier Pure-Aid CAMPHOR, MENTHOL, METHYL SALICYLATE Kareway Product, Inc. 6def9da7-e118-fd5c-e053-2991aa0a65d2 2018-06-05 Warnings Exact identifier Soundbody LIDOCAINE, MENTHOL Kareway Product, Inc. 6c83ec36-3e3d-07a9-e053-2a91aa0ac54c 2018-05-18 Warnings Exact identifier Avedana Cool Hot Ice MENTHOL Unipack, Inc. 619c8e3f-0cad-4eb1-8dbb-632f3db74ba3 2018-05-01 Warnings Exact identifier SunBurnt PLUS Pain Relief LIDOCAINE HYDROCHLORIDE Welmedix LLC dba Welmedix Consumer Healthcare 6363c695-f801-407d-a4e1-b0d9cfa0a273 2018-03-13 Warnings Exact identifier Pure-Aid LIDOCAINE, MENTHOL Kareway Product, Inc. 6679cada-f083-26e8-e053-2a91aa0adcc5 2018-03-02 Warnings Exact identifier
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warnings Warnings For external use only Avoid contact with eyes and mucous membranes • If conditions worsens, or if symtoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. • Do not apply to wounds or damaged skin. • Do not apply bandage tightly. • Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin. • Discontinue use if excessive irritation of skin develops. • If pregnant or breast feeding, ask a health professional before use. • A temporary burning sensation may occur upon application, but generally disappears in a few days.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-5694-01 00904569401 1 POUCH in 1 PACKAGE (0904-5694-01) > 5 PATCH in 1 POUCH 1 pouch 2013-06-30 0000-00-00 No No Current