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
2027-12-31
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
2027-12-31

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 46 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraCare Lidocaine Pain ReliefLIDOCAINEVeridian Healthcareee8cd550-64ee-432e-98e5-b68083179a3c2026-01-05WarningsExact identifier
application number: M017
REGENECARE HALIDOCAINE HCLMPM Medical LLC0eee554f-dfe0-433a-9665-8bdb952298882026-01-05WarningsExact identifier
application number: M017
Pain Relieving CreamCAMPHOR AND MENTHOLPAIN WIZARD LIMITED LIABILITY COMPANY2647bba1-87f4-3c16-e063-6394a90ae0c92026-01-05WarningsExact identifier
application number: M017
TheraCare Lidocaine plus MentholLIDOCAINE, MENTHOLVeridian Healthcareefddd116-d753-425a-9ded-09b8045024e42026-01-05WarningsExact identifier
application number: M017
TheraCare Original MentholMENTHOLVeridian Healthcareea56e4e1-a758-428b-8758-ee31bb00ca822026-01-05WarningsExact identifier
application number: M017
Mugwort Patch (Cervical spine use)2%MENTHOLYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED478e220c-0d35-9ee0-e063-6294a90ab6892026-01-04WarningsExact identifier
application number: M017
Mugwort Patch (Lumbar spine use)2%MENTHOLYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED478e4b21-6d81-4cd3-e063-6394a90a18fe2026-01-04WarningsExact identifier
application number: M017
Mugwort Patch (Knee use)2%MENTHOLYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED478e86d2-3030-91eb-e063-6394a90a4db02026-01-04WarningsExact identifier
application number: M017
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inc4a543f90-d43c-4487-b27e-f43394c6320d2026-01-04WarningsExact identifier
application number: M017
Doctor Hoys Pain Relief GelMENTHOL, CAMPHOR (SYNTHETIC)Dynamic Blending Specialists, Inc.50123bb9-d5d8-4ba6-ab94-8ed95fe0f5a82026-01-02WarningsExact identifier
application number: M017
Doctor Hoys Pain Relief Gel Roll-OnMENTHOL, CAMPHOR (SYNTHETIC)Dynamic Blending Specialists, Inc.bf47acb2-6c90-4d5c-820b-447cac9305a42026-01-02WarningsExact identifier
application number: M017
Amino Rip Muscle Pain ReliefLIDOCAINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2bed5764-4217-4aa3-9d90-3b5460dcffa32026-01-02WarningsExact identifier
application number: M017
Menthozen CreamMETHYL SALICYLATE, MENTHOL, CAPSAICINVillage Pharma LLC63bb0283-cfbe-4e9c-8772-73062c0c8d052026-01-01WarningsExact identifier
application number: M017
Menthozen HydrogelMENTHOL, CAPSAICINVillage Pharma LLC4c979a71-7c8f-4dff-abae-bf4cdf8f67b42026-01-01WarningsExact identifier
application number: M017
Lidozen GelLIDOCAINE HYDROCHLORIDE, MENTHOLVillage Pharma LLCffb7831f-4ca9-4d73-8303-e9cd900789822026-01-01WarningsExact identifier
application number: M017
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.116ee6dc-9c49-2e11-e063-6394a90a44ed2026-01-01WarningsExact identifier
application number: M017
MenthozenMETHYL SALICYLATE, MENTHOL, CAPSAICINVillage Pharma LLC48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb132026-01-01WarningsExact identifier
application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLJC SALES5adf457e-b4d0-30c8-e063-6294a90a64b92026-01-01WarningsExact identifier
application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLJC SALES490bc3b1-48bf-5437-e063-6394a90a90182026-01-01WarningsExact identifier
application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5ae00308-0a8c-065c-e063-6394a90aff6b2026-01-01WarningsExact 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