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 68 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PAINGEL UNGUENTO CAMPHOR, MENTHOL NACOR BUSINESS GROUP LLC 42fab525-b0a5-97fb-e063-6394a90aec6c 2025-11-06 Warnings Exact identifier application number: M017 PAINGEL ROLL-ON MENTHOL NACOR BUSINESS GROUP LLC 42fb0bdf-8bbd-bbe3-e063-6294a90a656c 2025-11-06 Warnings Exact identifier application number: M017 Coolexa CAMPHOR, MENTHOL, METHYL SALICYLATE Rising Pharma Holdings, Inc. 38839f29-d4ce-4684-a3c7-0bb4bf1ad594 2025-11-06 Warnings Exact identifier application number: M017 ndc (package): 57237-351-13 ndc (product): 57237-351 ndc11 (package): 57237035113 ItchZap DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Rising Pharma Holdings, Inc. 245d0afb-19a8-4cfb-968b-d892b18d5f2c 2025-11-06 Warnings Exact identifier application number: M017 Pain Relief Gel-Roll On LIDOCAINE AND MENTHOL Bullet point LLC 42c70681-494b-47c9-e063-6394a90a80be 2025-11-04 Warnings Exact identifier application number: M017 China-Gel Topical Pain Reliever MENTHOL AND CAMOHOR (SYNTHETIC) China-Gel, LLC ba6c7e97-d740-484b-8711-55fa7ab15784 2025-11-04 Warnings Exact identifier application number: M017 China-Gel MENTHOL AND CAMOHOR (SYNTHETIC) China-Gel, Inc. d7c5cb17-f7a2-7f57-e053-2995a90a40f7 2025-11-04 Warnings Exact identifier application number: M017 Aulief Topical Pain Reliever MENTHOL AND CAMOHOR China-Gel, LLC 8647dcc3-1dbc-1093-e053-2991aa0a1ab9 2025-11-04 Warnings Exact identifier application number: M017 China-Gel Topical Pain Reliever MENTHOL AND CAMOHOR (SYNTHETIC) China-Gel, LLC 254abae9-ef1b-5a90-e054-00144ff88e88 2025-11-04 Warnings Exact identifier application number: M017 Pain Relief Gel-Tube MENTHOL Bullet point LLC 42c93789-9758-54b7-e063-6394a90ac398 2025-11-04 Warnings Exact identifier application number: M017 Tattoo care TATTOO CARE CREAM Perfso (HK) Co., Limited 42d0f56f-9cb1-8e19-e063-6394a90aa3e0 2025-11-04 Warnings Exact identifier application number: M017 CORE RELIEF CAMPHOR, MENTHOL Copper Joint, LLC 42d17270-f58d-9d69-e063-6294a90a4078 2025-11-04 Warnings Exact identifier application number: M017 Lidocaine and Menthol LIDOCAINE AND MENTHOL Marcella Health d25f25ee-79f8-49e7-9715-0aae305b73e5 2025-11-03 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS NO TOUCH SPRAY Premier Brands of America Inc. 36481d67-2346-470b-e063-6294a90aae99 2025-11-03 Warnings Exact identifier application number: M017 Lidocaine Numbing Cream LIDOCAINE 5% YYBA Corp 1319ee69-8b3f-5815-e063-6294a90a5ad5 2025-11-03 Warnings Exact identifier application number: M017 Goodsense Extra Strength Cold and Hot Medicated MENTHOL Geiss, Destin and Dunn, Inc. 7585d111-775f-4fb6-a485-28cd99d88852 2025-10-31 Warnings Exact identifier application number: M017 Topcare Cold and Hot Medicated MENTHOL Topco Associates LLC 8739aedd-165c-5ae0-e053-2a91aa0afcd0 2025-10-31 Warnings Exact identifier application number: M017 CVS Medicated Heat 1 ct CAPSAICIN CVS Pharmacy, Inc. d41dce5b-e698-4930-8869-040b2a973f25 2025-10-31 Warnings Exact identifier application number: M017 Coralite Medicated Heat CAPSAICIN United Exchange Corp. a0b89c7e-80bc-43c4-840c-5fd567f60b21 2025-10-31 Warnings Exact identifier application number: M017 Dragon with Arnical Pain Relief MENTHOL Genomma Lab USA Inc. b4cbb7b6-cb71-9721-e053-2995a90a2b2c 2025-10-31 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