FDA.reportPublic FDA data

Calypxo Pain Relief

Product NDC
76420-450
11-digit product format
764200450
Labeler code
76420
Product ID
76420-450_07cec8ef-ecc9-ac49-e063-6294a90a6083
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate, Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Asclemed USA, Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-15
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
bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6Available 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
76420-450-12Calypxo Pain Relief113 g in 1 BOTTLECREAM1136

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-450-12GM - Gram76420-450e387b485-2d49-4f5c-bfa1-3c2fa94acbe012014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3ACALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]2
Methyl SalicylateACTIVE INGREDIENTLAV5U5022YCALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]2
MentholACTIVE MOIETYL7T10EIP3ACALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZCALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]2
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0XCALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]2
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COCALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]2
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNCALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]2
Diazolidinyl UreaINACTIVE INGREDIENTH5RIZ3MPW4CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]2
Isopropyl MyristateINACTIVE INGREDIENT0RE8K4LNJSCALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]2
MethylParabenINACTIVE INGREDIENTA2I8C7HI9TCALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]2
PropylParabenINACTIVE INGREDIENTZ8IX2SC1OHCALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]2
Sodium lauryl SulfateINACTIVE INGREDIENT368GB5141JCALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKCALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]2
WaterINACTIVE INGREDIENT059QF0KO0RCALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-450CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ASCLEMED USA, INC]6Current NDC, Legacy NDC, 1 package rows20231016_bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6.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 10 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gaayou NumbingDIBUCAINE HYDROCHLORIDE 0.5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4c290118-7880-2a98-e063-6294a90a4c032026-07-21WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain Relieving Cold GelCAMPHOR, MENTHOLActive and Innovative572792bb-2819-36c3-e063-6394a90aa5042026-07-21WarningsExact identifier
application number: M017
SYLVIRENE NUMBINGLIDOCAINE 4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a36edc5-5a89-afb5-e063-6294a90a02dd2026-07-21WarningsExact identifier
application number: M017
REINREUDE PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAINLIDOCAINE 4% PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAINJiangxi Yudexi Pharmaceutical Co., LTD4a45c1cb-c5ab-d872-e063-6394a90aab5d2026-07-21WarningsExact identifier
application number: M017
SERYNTH Muscle ComfortARNICA MONTANA HPUS 7% MUSCLE COMFORTJiangxi Yudexi Pharmaceutical Co., LTD4a4c10cd-f0c4-8731-e063-6394a90a10a52026-07-21WarningsExact identifier
application number: M017
DERMFREE MEDICATED LIPCAMPHOR 2.0% MEDICATED LIPJiangxi Yudexi Pharmaceutical Co., LTD4a4d62fb-8dfa-404a-e063-6294a90a385d2026-07-21WarningsExact identifier
application number: M017
NATUHEAL RELIEF Cream FOR ECZEMAHYDROCORTISONE ACETATE 1% RELIEF CREAM FOR ECZEMAJiangxi Yudexi Pharmaceutical Co., LTD4c92fed1-a8b4-bda8-e063-6394a90a8a332026-07-20WarningsExact identifier
application number: M017
REDCOOL Arnica BruiseARNICA MONTANA HPUS 7% ARNICA BRUISEJiangxi Zhongletang Pharmaceuticals Co.,Ltd.49911392-e55e-1a6b-e063-6394a90a9af02026-07-20WarningsExact identifier
application number: M017
Vamy HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD499197aa-f872-3abf-e063-6294a90aeda22026-07-20WarningsExact identifier
application number: M017
Subleef NUMBINGLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a201a6b-adde-c0a8-e063-6394a90a82852026-07-20WarningsExact identifier
application number: M017
PUVIDA NUMBINGMENTHOL 5% (W/W) NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4de4e317-2f4f-e5d6-e063-6394a90a06112026-07-20WarningsExact identifier
application number: M017
Careland Lidocaine Plus Menthol Pain Relieving Gel PatchesLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.8b607c03-a98f-445a-a69e-7625a76ac44b2026-07-20WarningsExact identifier
application number: M017
Yodo SalilOINTMENTLaboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.56812625-7eab-6a25-e063-6294a90a23fe2026-07-20WarningsExact identifier
application number: M017
VBBV NumbingLIDOCAINEJiashen International Trade Limited5716c36b-6e97-c294-e063-6394a90aaf5c2026-07-20WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINEPremier Brands of America Inc.560c29cc-2453-5d14-e063-6394a90a844f2026-07-17WarningsExact identifier
application number: M017
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.4981e9c3-2a19-aed8-e063-6294a90af2162026-07-17WarningsExact identifier
application number: M017
endurance wipeBENZOCAINEAbsorption Pharmaceuticals, LLC303db1de-94fc-4543-e063-6294a90a01b92026-07-17WarningsExact identifier
application number: M017
Professional Therapy MuscleCare pain relieving gel Extra StrengthCAMPHOR, MENTHOLActive and Innovative Inc.56d30c33-ef5a-c63d-e063-6294a90acd292026-07-17WarningsExact identifier
application number: M017
Mineral Ice Extreme Gel Alpine Fresh ScentMENTHOLCarlin Consumer Health LLC56d3ca3d-21e1-a40a-e063-6294a90a9ff42026-07-17WarningsExact identifier
application number: M017
DRAVYNOR TOPICAL ANALGESIC HEAT PatchMENTHOL 24MG CAPSAICIN 16MG TOPICAL ANALGESIC HEAT PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56b83ee8-8d86-9436-e063-6294a90a0c252026-07-16WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486874menthol 3 % / methyl salicylate 10 % Topical CreamPSNbd9d0bc0-5705-4c73-bcd6-f6cdb68e05b66
1486874menthol 30 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCDbd9d0bc0-5705-4c73-bcd6-f6cdb68e05b66
1486874menthol 3 % / methyl salicylate 10 % Topical CreamSYbd9d0bc0-5705-4c73-bcd6-f6cdb68e05b66
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 startMarketing endSampleExclude flagStatus
76420-450-1276420045012113 g in 1 BOTTLE (76420-450-12) 113 g2014-01-150000-00-00NoNoCurrent