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 107 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DCH Labs Cool and Heat Roll-On MENTHOL 16% Derma Care Research Labs, LLC d35d7720-44ce-3624-e053-2995a90a7fb4 2024-12-19 Warnings Exact identifier application number: M017 Dr Goldsons Pain MENTHOL 8%, METHYL SALICYLATE 30% Derma Care Research Labs, LLC fb34b0d3-ccc0-305e-e053-6394a90a231d 2024-12-19 Warnings Exact identifier application number: M017 Warrior Pain Relieving CAMPHOR 4%, MENTHOL 10%, METHYL SALICYLATE 30% Derma Care Research Labs, LLC dd06af3c-5452-9759-e053-2a95a90afc21 2024-12-19 Warnings Exact identifier application number: M017 Warrior Burn Relief Aloe Maximum Strength LIDOCAINE HCL 4% Derma Care Research Labs, LLC ec6efa4b-dcbe-1c2b-e053-2995a90ae043 2024-12-19 Warnings Exact identifier application number: M017 DCH Arthritis Relief TROLAMIN SALICYLATE 10% Derma Care Research Labs, LLC ff31e515-5780-b77d-e053-6394a90af6b9 2024-12-19 Warnings Exact identifier application number: M017 DCH Pain Relief LIDOCAINE 4% Derma Care Research Labs, LLC 00efda74-d434-04be-e063-6294a90a6d98 2024-12-19 Warnings Exact identifier application number: M017 Dollar General Cold Therapy Pain Relief MENTHOL 5% Dolgencorp, LLC ff3284d1-e73c-93bf-e053-6294a90aaf4e 2024-12-19 Warnings Exact identifier application number: M017 Dollar General Pain Relieving Patch with Lidocaine LIDOCAINE DOLGENCORP, LLC 55828cd1-3a1e-48ac-bb01-4c50b96d09a2 2024-12-19 Warnings Exact identifier application number: M017 DCH Nerve Pain Relief LIDOCAINE 4%, MENTHOL 1% Derma Care Research Labs, LLC 00db480a-e510-a64d-e063-6394a90a4695 2024-12-19 Warnings Exact identifier application number: M017 Pain, Burn, and Itch Relief BENZOCAINE 20%, MENTHOL 0.5% Derma Care Research Labs, LLC fd9fe09f-3ae9-c5f5-e053-6394a90ad691 2024-12-19 Warnings Exact identifier application number: M017 DCH Cooling Pain Relief MENTHOL 4% Derma Care Research Labs, LLC 00ed3175-c3ba-6545-e063-6394a90acfd1 2024-12-19 Warnings Exact identifier application number: M017 DCH Pain Relief LIDOCAINE HCL 4% Derma Care Research Labs, LLC 00dd70f3-ecc3-33ba-e063-6294a90a4f32 2024-12-19 Warnings Exact identifier application number: M017 Walgreens Kinesiology Pain Relief LIDOCAINE, MENTHOL Walgreen Co. 0fdbb310-8e65-4e0c-b413-a093964324a2 2024-12-19 Warnings Exact identifier application number: M017 Signature Care Medicated Cold and Hot Patch MENTHOL Safeway 0335f1b3-5c8a-67b8-e063-6294a90a9847 2024-12-19 Warnings Exact identifier application number: M017 HealthWise 4% Lidocaine Cream LIDOCAINE HYDROCHLORIDE Veridian Healthcare 0fb2af30-7f2d-c7c4-e063-6294a90a37f7 2024-12-19 Warnings Exact identifier application number: M017 CVS Health Lidocaine Pain Relief LIDOCAINE HCL CVS Pharmacy 445b0778-7266-4e72-97cc-e9e0d0066b61 2024-12-18 Warnings Exact identifier application number: M017 Dr. Scholls Blister Pain Relief Complete LIDOCAINE Scholl's Wellness Company LLC 26e3a678-b28f-588b-e063-6394a90ac025 2024-12-18 Warnings Exact identifier application number: M017 Dr. Scholls Blister Pain Relief Complete LIDOCAINE Scholl's Wellness Company LLC d860b339-48a0-405c-a67d-f7e7a31f6351 2024-12-18 Warnings Exact identifier application number: M017 TheraCare Pain Relief Lidocaine LIDOCAINE Veridian Healthcare cea6cdab-28a5-5bd0-e053-2a95a90a1295 2024-12-18 Warnings Exact identifier application number: M017 TheraCare Pain Relief Medicated LIDOCAINE AND MENTHOL Veridian Healthcare 0d092461-85fe-acf6-e063-6294a90a5aae 2024-12-18 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