Home NDC 57237-351 Coolexa
Product NDC 57237-351
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 95 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MUSCLE MENTHOL WATER-JEL TECHNOLOGIES 1af399af-07b0-4899-9bcc-1e244b63b1cf 2025-04-08 Warnings Exact identifier application number: M017 Lidocaine with Menthol LIDOCAINE HCL AND MENTHOL Kareway Product, Inc. 9ee46a5b-d00c-4254-e053-2995a90aeb3a 2025-04-08 Warnings Exact identifier application number: M017 Foster and Thrive Lidocaine Pain Relief Patch LIDOCAINE 4% Strategic Sourcing Services LLC 324802c9-e2c2-bf74-e063-6394a90a8697 2025-04-08 Warnings Exact identifier application number: M017 OARS AND ALPS MUSCLE RECOVERY BALM MENTHOL, METHYL SALICYLATE Cosco International, Inc 8745802f-018d-4cf8-bbf3-3b04c8f54538 2025-04-08 Warnings Exact identifier application number: M017 NOVUM APR MENTHOL NOVUM SOLUTIONS INC 1b869a1f-5787-4d03-a546-43a8217b2b2c 2025-04-07 Warnings Exact identifier application number: M017 MAG 5 PT ROLL-ON PAIN RELIEF COOLING MENTHOL RENU LABORATORIES, LLC 31e4fa2c-3a98-d618-e063-6394a90aec1c 2025-04-07 Warnings Exact identifier application number: M017 RockSauce FIERY HOT PAIN RELIEF METHYL SALICYLATE, MENTHOL, CAPSAICIN Implus Footcare, LLC cc7cbf4a-8274-e463-e053-2995a90a51e0 2025-04-07 Warnings Exact identifier application number: M017 RockSauce FIERY HOT PAIN RELIEF METHYL SALICYLATE, MENTHOL, CAPSAICIN Implus Footcare, LLC bdee018a-2c3c-3116-e053-2a95a90ac8d8 2025-04-07 Warnings Exact identifier application number: M017 RockSauce FIERY HOT PAIN RELIEF METHYL SALICYLATE, MENTHOL, CAPSAICIN Implus Footcare, LLC bdee2b65-2759-0e62-e053-2a95a90a0378 2025-04-07 Warnings Exact identifier application number: M017 RockSauce ICY COLD PAIN RELIEF MENTHOL Implus Footcare, LLC bdc7c7f3-ac98-8fe9-e053-2a95a90a2663 2025-04-07 Warnings Exact identifier application number: M017 RockSauce ICY COLD PAIN RELIEF MENTHOL Implus Footcare, LLC bd4fdff1-9174-31c2-e053-2a95a90a749f 2025-04-07 Warnings Exact identifier application number: M017 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
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 57237-351-57 57237035157 1 TUBE in 1 CARTON (57237-351-57) / 57 g in 1 TUBE 1 tube 2025-11-06 No No Current