FDA.reportPublic FDA data

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
IngredientStrength
CAMPHOR (SYNTHETIC)40 mg/g
MENTHOL, UNSPECIFIED FORM100 mg/g
METHYL SALICYLATE300 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283083Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
38839f29-d4ce-4684-a3c7-0bb4bf1ad594Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-351-13Coolexa1 in 1 CARTONCREAM11
57237-351-13Coolexa113 g in 1 TUBECREAM1131
57237-351-57Coolexa1 in 1 CARTONCREAM11
57237-351-57Coolexa57 g in 1 TUBECREAM571

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 8 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 4% PatchLIDOCAINEAldermed Inc.57994923-20fc-9d9d-e063-6394a90a22c92026-07-27WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINEAldermed Inc.579a5012-837a-828b-e063-6294a90a4fb22026-07-27WarningsExact identifier
application number: M017
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
application number: M017
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
application number: M017
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEFMENTHOLOWELL NATURAL 8 LLC57a124b4-66c6-2474-e063-6294a90ab0d72026-07-27WarningsExact identifier
application number: M017
Icy Hot Performance DryMENTHOL 16%, CAMPHOR 11%Chattem, Inc.8927570f-761b-4d83-8612-30077224fdb82026-07-27WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED578675e8-30e7-6986-e063-6394a90a8afe2026-07-26WarningsExact identifier
application number: M017
Do Me Delay CreamBENZOCAINEProdigy Media53d5cd6b-96b8-9ba2-e063-6294a90a0d152026-07-24WarningsExact identifier
application number: M017
Bravado Labs Delay CreamBENZOCAINEProdigy Media Inc57269544-9cfb-4ff0-e063-6394a90adb022026-07-24WarningsExact identifier
application number: M017
Zytherial Lidocaine 4% Pain Relief PatchLIDOCAINE 4% PAIN RELIEF PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56db5028-b631-7981-e063-6294a90ae3952026-07-24WarningsExact identifier
application number: M017
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsExact identifier
application number: M017
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsExact identifier
application number: M017
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
application number: M017
Arlun Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5765fbf1-e835-a11e-e063-6394a90a5ac22026-07-24WarningsExact identifier
application number: M017
DERMFREE PAIN RELIEFARNICA MONTANA HPUS 7% PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4bb74112-c4e7-7988-e063-6394a90ae3f12026-07-24WarningsExact identifier
application number: M017
SERYNTH HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4c667f3d-1238-2f02-e063-6394a90ab7422026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4ca7222b-d754-9861-e063-6294a90a1b7b2026-07-24WarningsExact identifier
application number: M017
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4ca7d0ca-6407-1fed-e063-6394a90aaccc2026-07-24WarningsExact identifier
application number: M017
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AIDNICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AIDJiangxi Yudexi Pharmaceutical Co., LTD4d5821f9-605e-5391-e063-6294a90afcd22026-07-24WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamPSN38839f29-d4ce-4684-a3c7-0bb4bf1ad5941
283083camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD38839f29-d4ce-4684-a3c7-0bb4bf1ad5941
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamSY38839f29-d4ce-4684-a3c7-0bb4bf1ad5941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57237-351-13572370351131 TUBE in 1 CARTON (57237-351-13) / 113 g in 1 TUBE1 tube2025-11-06NoNoCurrent
57237-351-57572370351571 TUBE in 1 CARTON (57237-351-57) / 57 g in 1 TUBE1 tube2025-11-06NoNoCurrent