Home NDC 65923-616 Sound Body Extra Strength Cold and Hot
Product NDC 65923-616
11-digit product format 659230616
Labeler code 65923
Product ID 65923-616_fbbed3fc-3353-4c01-aab2-eee8c7d43cc6
Type HUMAN OTC DRUG
Nonproprietary name Menthol, and Methyl Salcylate
Dosage form CREAM
Route TOPICAL
Labeler United Exchange Corp.
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2015-02-24
Marketing end 0000-00-00
Substance MENTHOL; METHYL SALICYLATE
Active strength 10 g/100g; g/100g
NDC exclude flag No
Listing certified through 2019-12-31
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 65923-616 I Inactivated by FDA 2026-07-31 excluded package package 65923-616 65923-616-35 I Inactivated by FDA 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
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65923-616-35 Sound Body Extra Strength Cold and Hot 1 in 1 CARTON CREAM 1 1 65923-616-35 Sound Body Extra Strength Cold and Hot 35.4 g in 1 TUBE CREAM 35.4 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MENTHOL ACTIVE INGREDIENT L7T10EIP3A SOUND BODY EXTRA STRENGTH COLD AND HOT (MENTHOL, AND METHYL SALCYLATE) CREAM [UNITED EXCHANGE CORP.] 1 METHYL SALICYLATE ACTIVE INGREDIENT LAV5U5022Y SOUND BODY EXTRA STRENGTH COLD AND HOT (MENTHOL, AND METHYL SALCYLATE) CREAM [UNITED EXCHANGE CORP.] 1 MENTHOL ACTIVE MOIETY L7T10EIP3A SOUND BODY EXTRA STRENGTH COLD AND HOT (MENTHOL, AND METHYL SALCYLATE) CREAM [UNITED EXCHANGE CORP.] 1 SALICYLIC ACID ACTIVE MOIETY O414PZ4LPZ SOUND BODY EXTRA STRENGTH COLD AND HOT (MENTHOL, AND METHYL SALCYLATE) CREAM [UNITED EXCHANGE CORP.] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS SOUND BODY EXTRA STRENGTH COLD AND HOT (MENTHOL, AND METHYL SALCYLATE) CREAM [UNITED EXCHANGE CORP.] 1 LANOLIN INACTIVE INGREDIENT 7EV65EAW6H SOUND BODY EXTRA STRENGTH COLD AND HOT (MENTHOL, AND METHYL SALCYLATE) CREAM [UNITED EXCHANGE CORP.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T SOUND BODY EXTRA STRENGTH COLD AND HOT (MENTHOL, AND METHYL SALCYLATE) CREAM [UNITED EXCHANGE CORP.] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M SOUND BODY EXTRA STRENGTH COLD AND HOT (MENTHOL, AND METHYL SALCYLATE) CREAM [UNITED EXCHANGE CORP.] 1 POTASSIUM CETYL PHOSPHATE INACTIVE INGREDIENT 03KCY6P7UT SOUND BODY EXTRA STRENGTH COLD AND HOT (MENTHOL, AND METHYL SALCYLATE) CREAM [UNITED EXCHANGE CORP.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH SOUND BODY EXTRA STRENGTH COLD AND HOT (MENTHOL, AND METHYL SALCYLATE) CREAM [UNITED EXCHANGE CORP.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SOUND BODY EXTRA STRENGTH COLD AND HOT (MENTHOL, AND METHYL SALCYLATE) CREAM [UNITED EXCHANGE CORP.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y SOUND BODY EXTRA STRENGTH COLD AND HOT (MENTHOL, AND METHYL SALCYLATE) CREAM [UNITED EXCHANGE CORP.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SOUND BODY EXTRA STRENGTH COLD AND HOT (MENTHOL, AND METHYL SALCYLATE) CREAM [UNITED EXCHANGE CORP.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65923-616 SOUND BODY EXTRA STRENGTH COLD AND HOT (MENTHOL, AND METHYL SALCYLATE) CREAM [UNITED EXCHANGE CORP.] 1 Legacy NDC, 2 package rows 20150225_098d1cc0-f77b-4c52-94e9-6bbe85f09a5f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 65923-616-35 65923061635 1 in 1 CARTON Historical