FDA.reportPublic FDA data

Calypxo Pain Relief

Product NDC
80425-0369
11-digit product format
804250369
Labeler code
80425
Product ID
80425-0369_2a994ea2-2575-6513-e063-6394a90a7bc2
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate, Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Advanced Rx of Tennessee, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-01
Substance
METHYL SALICYLATE; MENTHOL
Active strength
10; 3 g/100g; g/100g
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
Calypxo Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE10 g/100g
MENTHOL3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1486874Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0b7736df-c7e0-7d00-e063-6294a90aa57eAvailable 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
80425-0369-1Calypxo Pain Relief113 g in 1 BOTTLECREAM1132

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0369-1GM - Gram80425-0369d6e80a69-a19b-4556-94de-558b7c7ba37e12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0369CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 1 package rows20250101_0b7736df-c7e0-7d00-e063-6294a90aa57e.zip

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 101 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CBD Clinic Pain Relief - Level 5MENTHOL, CAMPHORABACUS HEALTH PRODUCTS, INC.f0ebbc0f-9888-b812-e053-2a95a90a5d3d2025-01-28WarningsExact identifier
application number: M017
CBDMEDIC Arthritis Aches and Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec7255-bb36-41cd-e053-2a95a90aeac42025-01-28WarningsExact identifier
application number: M017
CBDMEDIC Back and Neck Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec8fc9-c401-5f23-e053-2995a90acb1c2025-01-28WarningsExact identifier
application number: M017
Muscle TherapyMETHYL SALICYLATE, CAMPHOREverlaan Organics Inc0890a683-9a66-fdbd-e063-6294a90ae5262025-01-27WarningsExact identifier
application number: M017
Joint TherapyCAMPHOREverlaan Organics Inc08904b77-d6db-8b82-e063-6394a90ace4f2025-01-27WarningsExact identifier
application number: M017
Warrior Arthritis ReliefTROLAMIN SALICYLATE 10%Derma Care Research Labs, LLC013f48b9-913f-b283-e063-6394a90abd732025-01-27WarningsExact identifier
application number: M017
DCH Cool and HeatMENTHOL 16%Derma Care Research Labs, LLCff323282-612c-eaf8-e053-6394a90ab7792025-01-27WarningsExact identifier
application number: M017
GerigentleHYDROCORTISONEGERI-GENTLE CORPORATION0adfa2f0-9758-5c54-e063-6294a90a461f2025-01-25WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain RelievingMENTHOL, CAMPHORActive and Innovative Inc.42f1abeb-f6d7-01c3-e054-00144ff88e882025-01-23WarningsExact identifier
application number: M017
FORTHiQ Pain Relief Lidocaine PatchPAIN RELIEF LIDOCAINE PATCHHenan Enokon Medical Instrument Co., Ltd.2c593420-5788-3422-e063-6394a90a18902025-01-22WarningsExact identifier
application number: M017
RETALIEF LIDOCAINE 5LIDOCAINEReliable 1 Laboratories LLC2c262f3c-8cb2-4384-e063-6294a90a436d2025-01-20WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1c3e5068-dd61-ebdb-e063-6294a90a97cc2025-01-20WarningsExact identifier
application number: M017
PROHEAL BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab12025-01-19WarningsExact identifier
application number: M017
HERSTAT PLUS Cold Sore TreatmentCAMPHOR, MENTHOLHerstat (USA) Inc.e20ea714-663d-c4ac-e053-2a95a90a5ecc2025-01-18WarningsExact identifier
application number: M017
Pain Relief MedicatedCAMPHOR MENTHOL METHYL SALICYTATERITE AID CORPORATION60895211-69f3-478b-a33f-1c2071f629502025-01-16WarningsExact identifier
application number: M017
Elgin Pain ReliefMENTHOLEco-Logics, Inc.70eda21e-e566-42f4-9a49-b0d3ad0006522025-01-16WarningsExact identifier
application number: M017
Curist Lidocaine Patch Maximum StrengthLIDOCAINELittle Pharma, Inc.e574c188-cc65-287d-e053-2995a90a59722025-01-16WarningsExact identifier
application number: M017
Equate Hydrocortisone TopicalHYDROCORTISONEWalMart1f64555d-f77e-4a83-b222-fdb3ed7d88532025-01-16WarningsExact identifier
application number: M017
Equate HydrocortisoneHYDROCORTISONEWalMartf5c32b4a-1159-4b7a-b8ac-256d53020dc22025-01-16WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd296fcc36-563f-19ca-e063-6394a90ab3ae2025-01-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486874menthol 3 % / methyl salicylate 10 % Topical CreamPSN0b7736df-c7e0-7d00-e063-6294a90aa57e2
1486874menthol 30 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCD0b7736df-c7e0-7d00-e063-6294a90aa57e2
1486874menthol 3 % / methyl salicylate 10 % Topical CreamSY0b7736df-c7e0-7d00-e063-6294a90aa57e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0369-180425036901113 g in 1 BOTTLE (80425-0369-1) 113 g2023-12-01NoNoCurrent