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 2027-12-31
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 2027-12-31 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 138 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PERSONAL CARE ICE COLD MENTHOL NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. 1994356c-e347-5b7d-e063-6394a90a476c 2024-01-01 Warnings Exact identifier application number: M017 Dendracin Neurodendraxcin METHYL SALICYLATE, MENTHOL AND CAPSAICIN Proficient Rx LP 7e765fc1-74c6-4af3-a9cf-05b57011d7d8 2024-01-01 Warnings Exact identifier application number: M017 CeraVe Developed with Dermatologists Itch Relief Moisturizing PRAMOXINE HYDROCHLORIDE L'Oreal USA Products Inc c6a0880e-fc16-46e9-8314-c56c9d15bf31 2023-12-31 Warnings Exact identifier application number: M017 CeraVe Developed with Dermatologists Anti Itch HYDROCORTISONE L'Oreal USA Products Inc. 8d65e945-2557-486f-9279-ecbaa08f31c4 2023-12-31 Warnings Exact identifier application number: M017 Nighttime Sleep-Aid Non-Habit Forming DIPHENHYDRAMINE HCI AptaPharma Inc. ed0ba7aa-e794-43da-b576-6b9945bf7477 2023-12-30 Warnings Exact identifier application number: M017 Sting-Kill BENZOCAINE AND MENTHOL RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH b8bd9280-f20a-4b2a-aef7-a0ba7b3b8701 2023-12-29 Warnings Exact identifier application number: M017 Maybelline New York Baby Lips Dr Rescue Medicated Balm MENTHOL L'Oreal USA Products Inc 2f7b8221-66f6-4aed-8359-318cfc656a72 2023-12-28 Warnings Exact identifier application number: M017 Equate Cortisone HYDROCORTISONE 1% Walmart Inc 027fae33-93a0-a61f-e063-6294a90a990f 2023-12-27 Warnings Exact identifier application number: M017 Walgreens Cool n Heat Lidocaine LIDOCAINE HCL 4% Walgreens Co 0681c6c5-5a8b-ea9e-e063-6394a90a83bc 2023-12-27 Warnings Exact identifier application number: M017 EXTRA STRENGTH WAL-DRYL ITCH RELIEF DIPHENHYDRAMINE, ZINC ACETATE WALGREEN CO 681cf1af-2cc3-4e6d-b76f-f00731ea3e12 2023-12-27 Warnings Exact identifier application number: M017 XRay Pain Relief MENTHOL, (PLUS)-, CAMPHOR, (-)-, AND METHYL SALICYLATE Genomma Lab USA 5244ddee-fd9e-4df3-8fb3-b16aa321a316 2023-12-27 Warnings Exact identifier application number: M017 Camphor Spirit CAMPHOR 10% Pharma Nobis, LLC e42fbe63-b01c-4f85-e053-2a95a90a5143 2023-12-26 Warnings Exact identifier application number: M017 Equate Calaspray PRAMOXINE HCL 1%, ZINC ACETATE 0.1% Walmart Inc 027ed5ab-05ec-569f-e063-6394a90abbc3 2023-12-26 Warnings Exact identifier application number: M017 EXTERNAL ANALGESIC CAMPHOR, CAPSICUM, MENTHOL Hmong 21 3b6155a5-51aa-2780-e054-00144ff8d46c 2023-12-26 Warnings Exact identifier application number: M017 LEADER Camphor Spirit CAMPHOR (NATURAL) Cardinal Health, 110 dba Leader 7d3b0b28-5190-0622-e053-2991aa0af561 2023-12-22 Warnings Exact identifier application number: M017 Antiseptic Instant Pain Relief CAMPHOR 10.8% AND PHENOL 4.7% Pharma Nobis, LLC e42f484d-a642-3489-e053-2a95a90a4254 2023-12-22 Warnings Exact identifier application number: M017 Itch Relief Gel ITCH RELIEF GEL Pharma Nobis, LLC e42f484d-a641-3489-e053-2a95a90a4254 2023-12-22 Warnings Exact identifier application number: M017 Witch Hazel WITCH HAZEL Pharma Nobis, LLC e42f484d-a644-3489-e053-2a95a90a4254 2023-12-22 Warnings Exact identifier application number: M017 Dermoplast Pain relieving BENZOCAINE, MENTHOL Advantice Health dad00c95-4e11-3eec-e053-2a95a90a7a18 2023-12-21 Warnings Exact identifier application number: M017 equate Maximum Strength Pain Relieving 4% Lidocaine with Lavender Essential Oil Topical analgesic LIDOCAINE HYDROCHLORIDE Wal-Mart Stores, Inc. bf954949-a7b7-44ba-8565-f1d5c0a6c0d1 2023-12-21 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