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 24 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
A Health Itch Relief GelITCH RELIEF GELPharma Nobis, LLC4f80c403-c760-31ec-e063-6394a90a61c92026-04-15WarningsExact identifier
application number: M017
Family Care Antibiotic Pain Relief 0.33ozANTIBIOTIC PAIN RELIEFUnited Exchange Corp4f8405fc-3e38-05d9-e063-6394a90a4cda2026-04-15WarningsExact identifier
application number: M017
BiteMDINSECT BITE RELIEFWisconsin Pharmacal Company4f860c1e-a638-4923-e063-6294a90ae7e22026-04-15WarningsExact identifier
application number: M017
LavaDerm AfterSunMENTHOLYoung Living Essential Oils, LC.4fcddcf1-36db-2f1a-e054-00144ff8d46c2026-04-15WarningsExact identifier
application number: M017
Arlun Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.4f8b60f9-03e3-e731-e063-6294a90a3b0a2026-04-15WarningsExact identifier
application number: M017
tuiwaro Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.4f66178c-95d9-8c6a-e063-6294a90a2c092026-04-14WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll-OnLIDOCAINE 4%Pharma Nobis, LLC4f6d9a51-c42e-ca88-e063-6394a90a86592026-04-14WarningsExact identifier
application number: M017
Hot/Cold Menthol 16% Roll-OnHOT/COLD MENTHOL 16% ROLL-ONPharma Nobis, LLC4f6f5a0b-3bfa-289e-e063-6294a90a94b32026-04-14WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINE4 Visions LLC4f76a8c5-fde6-eee0-e063-6394a90a09f82026-04-14WarningsExact identifier
application number: M017
Signature Pain Relief Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD4f555b8f-5193-e685-e063-6294a90a7ba22026-04-13WarningsExact identifier
application number: M017
Deep Numbing CreamMENTHOLYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD7943559b-de10-4214-96dc-f9cbac828f462026-04-13WarningsExact identifier
application number: M017
Hydrocortisone Cream 1%HYDROCORTISONE CREAM 1% WITH ALOEPublix Super Markets Inc.3c45a654-7fec-55b3-e063-6294a90a184b2026-04-13WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%AMERISOURCE BERGEN4f5aea1c-ae51-4e1a-e063-6294a90a6aa12026-04-13WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP8465b443-abe9-78fb-e053-2a91aa0ac1d82026-04-13WarningsExact identifier
application number: M017
4JointzMENTHOLARP(USA) Pty Ltd94a5b5f5-abf7-40b3-9dd7-43e2c22f138e2026-04-13WarningsExact identifier
application number: M017
Sumifun Pain Relief CreamsMETHYL SALICLATE CAPSAICIN CAMPHORGuchutang Biotechnology (Longyan) Co., Ltd4f3dd96a-d843-d810-e063-6394a90a188e2026-04-12WarningsExact identifier
application number: M017
BonicaEaseX 24 Hour Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co., Ltd.17fc0cd1-710d-45e6-9513-d7100e3adb422026-04-10WarningsExact identifier
application number: M017
BonicaEaseX Colorless Roll-On Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co.,Ltdacf460b4-1b41-4b30-a74a-6c3613119d8e2026-04-10WarningsExact identifier
application number: M017
BonicaEaseX Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co.,Ltd4d84b4fb-8f55-4b2b-b261-858edb7f31442026-04-10WarningsExact identifier
application number: M017
HealthWise Pain Relief Gel PatchCAPSAICIN, MENTHOLVeridian Healthcaref5484151-b6da-4f64-867f-87160a4ec2d62026-04-10WarningsExact 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