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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
38839f29-d4ce-4684-a3c7-0bb4bf1ad594	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 125 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Herb Street Arthritis Relief	MENTHOL/CAMPHOR	Balassa Laboratories Inc.	a9d8ceb7-def0-415f-8fc1-ff8dd3e41855	2024-10-01	Warnings	Exact identifier application number: M017
Lido King Lidocaine 4% Pain Relieving Gel-Patch	LIDOCAINE	Galaxy Bio, Inc.	2243734a-4ea2-a5e5-e063-6294a90aba15	2024-10-01	Warnings	Exact identifier application number: M017
Medicated Herbal Lip Balm	MENTHOL	Earth Mama Angel Baby LLC	1cc2391e-6a7a-609c-e063-6394a90a6305	2024-10-01	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Plus Pain Relieving	LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL	NATURAL ESSENTIALS, INC.	1adb9b74-4a01-4461-b845-f3aedcb3f810	2024-10-01	Warnings	Exact identifier application number: M017
Circata	CAPSAICIN	PureTek Corporation	b67161d7-cc5c-e971-e053-2995a90acbe7	2024-10-01	Warnings	Exact identifier application number: M017
Menticam	CAMPHOR,MENTHOL, METHYL SALICYLATE	PureTek Corporation	ffea2e97-777f-434b-e053-6394a90a3a63	2024-10-01	Warnings	Exact identifier application number: M017
Herb Street Sore Muscle Relief	METHYL SALICYLATE	Balassa Laboratories Inc.	e43943c2-d4cd-44c5-a0ff-403a8d42860f	2024-10-01	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Kroger Company	68dab606-0385-48b7-9a7b-a2cf83d20393	2024-09-29	Warnings	Exact identifier application number: M017
kirkland signature hydrocortisone plus maximum strength	HYDROCORTISONE	Costco Wholesale Company	481341c5-db1f-43fb-aed7-f40495a4eab8	2024-09-29	Warnings	Exact identifier application number: M017
Care One hydrocortisone maximum strength	HYDROCORTISONE	American Sales Company	32593229-d0ac-4d6c-831a-089fc6e76152	2024-09-29	Warnings	Exact identifier application number: M017
good sense anti itch	HYDROCORTISONE	L. Perrigo Company	b7a896cc-1d78-45c0-a73e-aa1e117f7d3b	2024-09-29	Warnings	Exact identifier application number: M017
Topcare Hydrocortisone	HYDROCORTISONE	Topco Associates LLC	b7362f21-f1a3-4edc-b5b6-a16680e05df3	2024-09-29	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	H E B	412ca2d1-064b-4438-aee1-fcb5cf27c7db	2024-09-29	Warnings	Exact identifier application number: M017
Topcare Antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	Topco Associates LLC	8c349cac-20e1-4600-9b0a-fcfe929551c5	2024-09-26	Warnings	Exact identifier application number: M017
good sense anti itch	HYDROCORTISONE	A-S Medication Solutions	072dd455-24a5-4a44-aaef-d3e137d005a6	2024-09-26	Warnings	Exact identifier application number: M017
SYREN Intimate Relief	LIDOCAINE HYDROCHLORIDE	Icon Health Science	57d5a080-3583-4510-e053-2a91aa0ad589	2024-09-25	Warnings	Exact identifier application number: M017
AOSI HEALTHCARE	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	f4db90ad-dd62-44f1-9655-2614ed36581e	2024-09-25	Warnings	Exact identifier application number: M017
AOSI HEALTHCARE BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	a28b920c-0bb8-4b5a-addd-26ea164e036e	2024-09-25	Warnings	Exact identifier application number: M017
anti itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Kroger Company	067e718a-ec0b-4895-8f9f-82d64ab4c7b4	2024-09-24	Warnings	Exact identifier application number: M017
topcare anti itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Topco Associates LLC	e0fb332a-2903-41ef-b35b-7cd3a74cff99	2024-09-24	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283083	camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical Cream	PSN	38839f29-d4ce-4684-a3c7-0bb4bf1ad594	1
283083	camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical Cream	SCD	38839f29-d4ce-4684-a3c7-0bb4bf1ad594	1
283083	camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical Cream	SY	38839f29-d4ce-4684-a3c7-0bb4bf1ad594	1

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Camphor 4%, Menthol 10%, Methyl Salicylate 30% Topical analgesic cream ULTRA STRENGTH	Rising Pharma Holdings, Inc. \| Elysium Pharmaceuticals Ltd	2025-11-06	HUMAN OTC DRUG LABEL	1