NDC 59088-435 - Lextol

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
59088-435
Package NDCs from labels
59088-435-10
Manufacturer
PureTek Corporation
Effective date
2025-12-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lextol - PureTek CorporationPureTek Corporation2025-12-19HUMAN PRESCRIPTION DRUG LABEL
Lixofen - PureTek CorporationPureTek Corporation2025-12-18HUMAN PRESCRIPTION DRUG LABEL
Diclogen - PureTek CorporationPureTek Corporation2025-12-18HUMAN PRESCRIPTION DRUG LABEL
Diclofenac Sodium - Direct_RxDirect_Rx2025-01-22HUMAN PRESCRIPTION DRUG LABEL
Diclofenac Sodium - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL
Diclofenac Sodium - PureTek CorporationPureTek Corporation2024-10-25HUMAN PRESCRIPTION DRUG LABEL
Diclofenac Sodium - UNIT DOSE SERVICESUNIT DOSE SERVICES2023-02-15HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-435-10Diclofenac Sodium1 in 1 CARTONSOLUTION14
59088-435-10Diclofenac Sodium150 mL in 1 BOTTLE, DROPPERSOLUTION1504
59088-435-10Lextol1 in 1 CARTONSOLUTION16.05 mg in 1mL3
59088-435-10Lixofen1 in 1 CARTONSOLUTION16.05 mg in 1mL3
59088-435-10Diclogen150 mL in 1 BOTTLE, DROPPERSOLUTION150 mL16.05 mg in 1mL3
59088-435-10Diclogen1 in 1 CARTONSOLUTION16.05 mg in 1mL3
59088-435-10Lixofen150 mL in 1 BOTTLE, DROPPERSOLUTION150 mL16.05 mg in 1mL3
59088-435-10Lextol150 mL in 1 BOTTLE, DROPPERSOLUTION150 mL16.05 mg in 1mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-435DICLOFENAC SODIUM SOLUTION [PURETEK CORPORATION]42 package rows20241105_f267b75c-e141-41dd-e053-2995a90afe30.zip
59088-435DICLOGEN (DICLOFENAC SODIUM, CAMPHOR AND MENTHOL) KIT [PURETEK CORPORATION]2Unmatched20241208_1e2bb4e5-bb65-48a0-e063-6294a90a54d1.zip
59088-435LEXTOL (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]2Unmatched20241208_042765e5-bd75-8224-e063-6394a90a141b.zip
59088-435LIXOFEN (DICLOFENAC SODIUM, KINESIOLOGY TAPE) KIT [PURETEK CORPORATION]2Unmatched20241208_1e2a687b-a838-9b16-e063-6394a90a69f3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-435-10ML - Milliliter59088-4352c2a3b20-c6f8-4d5d-8a58-d7ddf8cc855812023-02-06