FDA.reportPublic FDA data

Capasil

Product NDC
59088-434
11-digit product format
590880434
Labeler code
59088
Product ID
59088-434_2372ecc1-5f76-b714-e063-6394a90ad579
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
2020-10-14
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
Capasil
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
b1a8e78c-57f0-1f3e-e053-2995a90acbd5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-434-05CapasilPain Relieving59 mL in 1 JARCREAM592

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-434-05ML - Milliliter59088-434b825e733-7b1a-479b-a124-fd7027f0411012021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-434CAPASIL PAIN RELIEVING (MENTHOL, METHYL SALICYLATE) CREAM [PURETEK CORPORATION]2Current NDC, Legacy NDC, 1 package rows20241004_b1a8e78c-57f0-1f3e-e053-2995a90acbd5.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 18 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OASIS Tears Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.d9d71b1d-82a6-42e7-9ef2-2d041daef9362024-12-23WarningsExact identifier
application number: M018
Ancient Secrets Breathe AgainSODIUM CHLORIDELOTUS BRANDS, INC.c6d2bab0-d363-4c09-a71b-ae15db915b372024-12-18WarningsExact identifier
application number: M018
TheraTears ExtraCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMMEDTECH PRODUCTS INC77f504c1-b8e0-4371-ac3e-9d453d84714b2024-12-13WarningsExact identifier
application number: M018
TheraTears ExtraCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDMEDTECH PRODUCTS INCf1845041-9d8d-42a0-a2cb-68def7a5aac72024-12-13WarningsExact identifier
application number: M018
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
application number: M018
Systane NighttimeMINERAL OIL AND WHITE PETROLATUMAlcon Laboratories, Inc.4689c59c-5721-3f91-6c85-e41501998fd02024-12-05WarningsExact identifier
application number: M018
GenTeal Tears NIGHT-TIMEMINERAL OIL, WHITE PETROLATUMAlcon Laboratories, Inc.9d5998a7-4f59-4293-87da-8419650a524d2024-12-05WarningsExact identifier
application number: M018
Visine Red Eye Total Comfort and Tears Dry Eye ReliefTETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATEKenvue Brands LLC0bc0d6e7-9195-db6b-e063-6294a90aef042024-11-14WarningsExact identifier
application number: M018
Visine Red Eye ComfortTETRAHYDROZOLINE HYDROCHLORIDEKenvue Brands LLCd7abd7cb-e094-481f-bea5-a5983e2c9ef42024-11-13WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Kenvue Brands LLCa9a90de6-3172-4d34-984b-f4442f880e3d2024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLC2de7a41d-661d-495f-89b4-5690664a3a3d2024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye Relief Eye DropsPOLYETHYLENE GLYCOL 400Kenvue Brands LLCd9d3f000-3ce4-4ba2-a7fb-491b44eb3fa12024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLCa4c57620-778f-4434-9105-ead2f85c58842024-11-13WarningsExact identifier
application number: M018
Visine A.C. Itchy Eye ReliefTETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC257b9666-0163-499b-9673-bf6f4d6899b12024-11-13WarningsExact identifier
application number: M018
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLAcme United Corporationf19fbe28-b928-7c6e-e053-2995a90a43cb2024-11-09WarningsExact identifier
application number: M018
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
application number: M018
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
application number: M018
Clear Eyes Cooling Redness ReliefGLYCERIN AND NAPHAZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.38d14e99-e4c8-431b-b106-578eeb38bf3c2024-10-25WarningsExact identifier
application number: M018
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
application number: M018
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311503menthol 2 % / methyl salicylate 10 % Topical CreamPSNb1a8e78c-57f0-1f3e-e053-2995a90acbd52
311503menthol 20 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCDb1a8e78c-57f0-1f3e-e053-2995a90acbd52
311503menthol 2 % / methyl salicylate 10 % Topical CreamSYb1a8e78c-57f0-1f3e-e053-2995a90acbd52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-434-055908804340559 mL in 1 JAR (59088-434-05) 59 ml2020-10-140000-00-00NoNoCurrent