Home NDC 57237-351-13 Coolexa
Product NDC 57237-351
Requested package NDC 57237-351-13
11-digit product format 572370351
Labeler code 57237
Product ID 57237-351_9e551d98-76bc-4d63-9462-006e858528fb
Type HUMAN OTC DRUG
Nonproprietary name Camphor, Menthol, Methyl Salicylate
Dosage form CREAM
Route TOPICAL
Labeler Rising Pharma Holdings, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-11-06
Substance CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength 40; 100; 300 mg/g; mg/g; mg/g
NDC exclude flag No
Listing certified through 2026-12-31
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 Coolexa
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAMPHOR (SYNTHETIC) 40 mg/g MENTHOL, UNSPECIFIED FORM 100 mg/g METHYL SALICYLATE 300 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5TJD82A1ET Internal UNII lookup L7T10EIP3A Internal UNII lookup LAV5U5022Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283083 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57237-351-13 Coolexa 1 in 1 CARTON CREAM 1 1 57237-351-13 Coolexa 113 g in 1 TUBE CREAM 113 1 57237-351-57 Coolexa 1 in 1 CARTON CREAM 1 1 57237-351-57 Coolexa 57 g in 1 TUBE CREAM 57 1
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 104 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocare Arm, Neck, Leg 4% LIDOCAINE Kingsway Pharmaceuticals dba NFI, LLC 59a104ee-7034-99c3-e053-2991aa0a164c 2025-01-06 Warnings Exact identifier application number: M017 Salonpas LIDOCAINE Pain Relieving LIDOCAINE Hisamitsu Pharmaceutical Co., Inc. 4f3a438c-f378-4d2a-a95c-58e56cf1e797 2025-01-06 Warnings Exact identifier application number: M017 Lidocare 03 4% LIDOCAINE Kingsway Pharmaceuticals dba NFI, LLC 416ebf5a-2efb-6d0b-e054-00144ff88e88 2025-01-06 Warnings Exact identifier application number: M017 AVCOO Pain Relief Roll-on MENTHOL ADP Health Limited e0bb77b2-45ee-45fa-9659-9c7d99bb20dc 2025-01-05 Warnings Exact identifier application number: M017 health and beyond BURN LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE Nantong Health & Beyond Hygienic Products Inc. 0b6bb3ed-50fb-40c4-acb6-ae3f16031531 2025-01-05 Warnings Exact identifier application number: M017 glo SKIN BEAUTY Remedy Gel GLO SKIN BEAUTY REMEDY GEL Hayden Caleel LLC aa47ff08-07b3-4fd1-bae5-420e4b928f06 2025-01-05 Warnings Exact identifier application number: M017 Capsaicin 0.025% Cream CAPSAICIN 0.025% Puretek Corporation 28f00df0-c416-f17b-e063-6294a90a5570 2025-01-02 Warnings Exact identifier application number: M017 AVON HeXashield Pain Relief for Muscle, Back and Joint Cream CAMPHOR, MENTHOL, METHYL SALICYLATE Tai Guk Pharm. Co., Ltd. 8f29ffd7-48b9-109f-e053-2995a90ab215 2025-01-01 Warnings Exact identifier application number: M017 AVON HeXashield Arthritis Pain Relief Cream Capsaisin CAPSAISIN Tai Guk Pharm. Co., Ltd. 8f286a9d-8765-21b3-e053-2a95a90ae43a 2025-01-01 Warnings Exact identifier application number: M017 AVON HeXashield Anti Itch Cream with Healing Aloe HYDROCORTISONE Tai Guk Pharm. Co., Ltd. 8f2aa11d-d794-6f3e-e053-2995a90a1d9d 2025-01-01 Warnings Exact identifier application number: M017 HeXashield Anti Itch Cream with Healing Aloe HYDROCORTISONE Tai Guk Pharm. Co., Ltd. b9d033f3-4d12-a2c8-e053-2995a90ac7f1 2025-01-01 Warnings Exact identifier application number: M017 Green Compass Reduce Pain Relief with Menthol MENTHOL Green Compass, Inc. 0a0c212e-ae5d-8505-e063-6394a90af622 2025-01-01 Warnings Exact identifier application number: M017 Green Compass Reduce Pain Relief CAMPHOR, MENTHOL, METHYL SALICYLATE Green Compass, Inc. 0a0b688e-50f1-3eb1-e063-6394a90a7efa 2025-01-01 Warnings Exact identifier application number: M017 Green Compass Reduce Topical Pain CAMPHOR, MENTHOL, METHYL SALICYLATE Green Compass, Inc. 8cb80362-5d24-1ee3-e053-2a95a90afcdf 2025-01-01 Warnings Exact identifier application number: M017 OKeeffes Working Hands Pain Relief Skin Protectant ALLANTOIN, LIDOCAINE HYDROCHLORIDE The Gorilla Glue Company/O'Keeffe's Company 0685da25-c9fa-e1cd-e063-6394a90ae1b3 2025-01-01 Warnings Exact identifier application number: M017 Icy Hot with Lidocaine Pain Relieving LIDOCAINE HCL AND MENTHOL Chattem, Inc. 75b28b06-77ea-4fea-b516-2e8a0dac7037 2025-01-01 Warnings Exact identifier application number: M017 Advanced Seal Barrier plus Pain Relief LIDOCAINE Kericure Inc. 7ac95325-e6e9-4c56-9315-876c00af7c98 2025-01-01 Warnings Exact identifier application number: M017 FixMySkin Healing Balm Fragrance-Free HYDROCORTISONE Lovely Skin, Inc. c12af4c6-2f05-46ec-b901-1a4fcd750180 2024-12-31 Warnings Exact identifier application number: M017 Pain Relieving Cream Lidocaine BENZYL ALCOHOL, LIDOCAINE HCI Trifecta Pharmaceuticals USA LLC 039a2036-54b2-cf28-e063-6294a90a8ce6 2024-12-31 Warnings Exact identifier application number: M017 Cold Therapy Pain Relief Walgreens MENTHOL 10.5% WALGREEN COMPANY f1daa68d-1b12-c28a-e053-2995a90a0949 2024-12-31 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 57237-351-13 57237035113 1 TUBE in 1 CARTON (57237-351-13) / 113 g in 1 TUBE 1 tube 2025-11-06 No No Current