Mencylate

Product NDC
59088-215
11-digit product format
590880215
Labeler code
59088
Product ID
59088-215_23734cfb-47fb-fb71-e063-6394a90a85de
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Methyl Salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
PureTek Corporation
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-24
Substance
METHYL SALICYLATE; MENTHOL
Active strength
100; 20 mg/mL; mg/mL
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
Mencylate
Brand name suffix
Pain Relieving
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE100 mg/mL
MENTHOL20 mg/mL

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
311503Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f824de86-9492-2e6b-e053-6294a90a6f2aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-215-05MencylatePain Relieving59 mL in 1 JARCREAM593

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-215-05ML - Milliliter59088-215cabea204-fd22-4a34-ac6a-0b1e4daad14b12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-215MENCYLATE PAIN RELIEVING (MENTHOL, METHYL SALICYLATE) CREAM [PURETEK CORPORATION]3Current NDC, 1 package rows20241004_f824de86-9492-2e6b-e053-6294a90a6f2a.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 17 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
application number: M018
Code Red Eye Drops Redness ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL4 Trees, LLC0aa08018-cc2d-d947-e063-6394a90a914a2025-02-07WarningsExact identifier
application number: M018
Tyson 2.0 Mike Red Eye Drops For Dry High EyesGLYCERIN, NAPHAZOLINE HCLJbrands Pharma L.L.C.288e9c85-0562-89bf-e063-6394a90a110d2025-02-07WarningsExact identifier
application number: M018
Sodium Chloride Normal SaltSODIUM CHLORIDECitragen Pharmaceuticals Incaae783b2-18fe-69ca-e053-2a95a90a08002025-01-30WarningsExact identifier
application number: M018
Sodium Chloride Normal SaltSODIUM CHLORIDECitragen Pharmaceuticals Inc82c29f1d-a018-7483-e053-2a91aa0a8f7e2025-01-30WarningsExact identifier
application number: M018
OASIS Tears Lubricant EyeGLYCERINOASIS Medical, Inc.00071697-4ac6-4962-8eee-388b8b52bd402025-01-22WarningsExact identifier
application number: M018
ImproVue LubricantHYPROMELLOSE 2208 (15000 MPA.S)Oculus Surgical, Inc.63b82129-4848-47c5-bf92-ec4b1a9e99742025-01-22WarningsExact identifier
application number: M018
VISCO SHIELD LubricantHYPROMELLOSE 2208 (15000 MPA.S)OASIS Medical, Inc.72d22610-d8ab-4f24-b304-8b013430a7d72025-01-22WarningsExact identifier
application number: M018
OASIS Tears Plus Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.ea931c0f-c61e-4771-84f1-0274b1c3e28e2025-01-22WarningsExact identifier
application number: M018
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
application number: M018
Sodium Chloride Hypertonicity Ophthalmic Solution, 5%SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5%Reliable 1 Laboritories LLC29175c17-223e-5e92-e063-6294a90a71d22025-01-15WarningsExact identifier
application number: M018
Lubricating TearsCARBOXYMETHYLCELLULOSE SODIUM 0.5% SOLUTIONReliable 1 Laboritories LLC29023a57-eba3-4241-e063-6294a90a70482025-01-15WarningsExact identifier
application number: M018
Aurodone Povidone Iodine 5 % Opthalmic SolutionPOVIDONE IODINE 5 % TOPICAL SOLUTIONAurolabf3444446-1dad-79ff-e053-2a95a90af4112025-01-06WarningsExact identifier
application number: M018
Hypromellose Eye Drops 0.7%HYPROMELLOSE EYE DROPS 0.7%Aurolabd35313d0-b190-5fb0-e053-2a95a90a52832025-01-02WarningsExact identifier
application number: M018
VISTA MEIBO TEARS Propylene Glycol 0.6% w/v Advanced Dry Eye Relief Lubricating Drops 10 mlPROPYLENE GLYCOLRed Wedding LLCb2c2fd0f-b944-6b0b-e053-2995a90aa2162025-01-01WarningsExact identifier
application number: M018
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
application number: M018
Lubricant Eye PMMINERAL OIL, WHITE PETROLATUMReliable 1 Laboratories LLCbaec8045-97fe-6f60-e053-2a95a90a050e2024-12-31WarningsExact identifier
application number: M018
Lil Drug Store Eye Drops Redness RelieverTETRAHYDROZOLINE HYDROCHLORIDELil Drug Store Products, Incd2a47e98-a04c-47ec-aded-d1c894f040e22024-12-30WarningsExact identifier
application number: M018
Rain Renewal Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRain Eye Drops, LLCaf7a5768-7d1d-3d93-e053-2a95a90a38f62024-12-29WarningsExact identifier
application number: M018
Glitch Advanced Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLMisemer Pharmaceutical, Inc03778509-3374-2168-e063-6294a90a95052024-12-23WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311503menthol 2 % / methyl salicylate 10 % Topical CreamPSNf824de86-9492-2e6b-e053-6294a90a6f2a3
311503menthol 20 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCDf824de86-9492-2e6b-e053-6294a90a6f2a3
311503menthol 2 % / methyl salicylate 10 % Topical CreamSYf824de86-9492-2e6b-e053-6294a90a6f2a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-215-055908802150559 mL in 1 JAR (59088-215-05) 59 ml2023-03-24NoNoCurrent