FDA.reportPublic FDA data

NDC 70000-0338-01 - Terbinafine Hydrochloride

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
70000-0338
Requested NDC
70000-0338-01
Package NDCs from labels
70000-0338-1, 70000-0338-01
Manufacturer
Cardinal Health, 110 dba LEADER | Sun Pharma Canada Inc.
Effective date
2025-07-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Terbinafine HydrochlorideCardinal Health, 110 dba LEADER | Sun Pharma Canada Inc.2025-07-09HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0338-1Terbinafine Hydrochloride1 in 1 CARTONCREAM13
70000-0338-1Terbinafine Hydrochloride15 g in 1 TUBECREAM153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0338TERBINAFINE HYDROCHLORIDE CREAM [CARDINAL HEALTH, 110 DBA LEADER]2Current NDC, Legacy NDC, 2 package rows20210622_a9412747-c7f9-4242-91ed-3695f372f6c9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0338-1GM - Gram70000-033808cddf4e-185b-4cb0-ae5a-a2a9d761d3b112019-09-05

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 5 of 13 · 260 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Zilactin Early Relief Cold SoreBENZYL ALCOHOLASCENT CONSUMER PRODUCTS, INC42ef8bfa-c4d9-01cf-e063-6394a90ac88a2025-11-06WarningsExact identifier
unii: LKG8494WBH
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Good Neighbor PharmacyTERBINAFINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.0a9e890c-1eed-4fde-a484-852a4dd135c22025-10-17WarningsExact identifier
application number: ANDA077511
rxcui: 992528
unii: 012C11ZU6G
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2df111dc-ecac-4161-9e22-38436eb37c1f2025-10-17Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
TerbinafineTERBINAFINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.747fdc13-7c3a-4672-b50c-31c51037bda22025-10-14Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G
Lamisil AT CreamTERBINAFINE HYDROCHLORIDEKaro Healthcare Inc.1aa5e03a-432b-4154-ab6e-6dbce7a671092025-10-02WarningsExact identifier
rxcui: 992528
unii: 012C11ZU6G
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
CVS Pharmacy Athletes FootTERBINAFINE HYDROCHLORIDECVS Pharmacy98a4ed66-2813-49de-8cda-94c41cc3ca9f2025-09-25WarningsExact identifier
application number: ANDA077511
rxcui: 992528
unii: 012C11ZU6G
Athletes FootTERBINAFINE HYDROCHLORIDEPublix Super Markets Inc.58293d62-089d-49ab-b691-dfd705ac9a9c2025-09-25WarningsExact identifier
application number: ANDA077511
rxcui: 992528
unii: 012C11ZU6G
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TerbinafineTERBINAFINECipla USA Inc.18b16aad-1877-4b07-b532-f0ef4843af912025-09-19Warnings, Adverse reactionsExact identifier
unii: 012C11ZU6G

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.