FDA.reportPublic FDA data

NDC 70000-0357-01 - Leader Tioconazole 1

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
70000-0357
Requested NDC
70000-0357-01
Package NDCs from labels
70000-0357-1, 70000-0357-01
Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2025-02-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Leader Tioconazole 1 - Cardinal Health 110, LLC. dba LeaderCardinal Health 110, LLC. dba Leader2025-02-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0357-1Leader Tioconazole 11 in 1 CARTONOINTMENT13
70000-0357-1Leader Tioconazole 14.6 g in 1 APPLICATOROINTMENT4.63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0357LEADER TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [CARDINAL HEALTH 110, LLC. DBA LEADER]3Current NDC, Legacy NDC, 2 package rows20250302_6db31d83-acd7-4e4e-8f98-fe46102a6832.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0357-1GM - Gram70000-03576b043d47-1caa-4787-9db2-bdd503b5267312019-03-12

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 20 of 27 · 535 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCfe18fa61-83f9-8bf9-e053-6294a90a75852024-12-18WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc59dcb2a-392b-670b-e053-2995a90a96822024-12-18WarningsExact identifier
unii: 4T6H12BN9U
TheraCare HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLVeridian Healthcarefab95657-d257-e671-e053-6294a90a59e02024-12-18WarningsExact identifier
unii: 4T6H12BN9U
Meijer Petroleum JellyWHITE PETROLATUMMeijer Distribution, Incb299cf2a-2c6a-68f4-e053-2995a90a5bd72024-12-18WarningsExact identifier
unii: 4T6H12BN9U
Caring Mills Petroleum JellyWHITE PETROLATUMVeridian Healthcarefbbfa780-0e2b-1874-e053-6394a90a5eeb2024-12-18WarningsExact identifier
unii: 4T6H12BN9U
TheraCare Petroleum JellyWHITE PETROLATUMVeridian Healthcared6fad49b-8a49-7f7c-e053-2a95a90ae6382024-12-18WarningsExact identifier
unii: 4T6H12BN9U
CareOne Tioconazole 1TIOCONAZOLEAmerican Sales Company78139c20-6258-4da6-abd3-9ba5e5899fd92024-12-18WarningsExact identifier
application number: ANDA075915
rxcui: 198380
unii: S57Y5X1117
Tioconazole 1TIOCONAZOLEWalgreen Companyc05a4413-8a5f-4b91-9c22-b1db785e8e9e2024-12-18WarningsExact identifier
application number: ANDA075915
rxcui: 198380
unii: S57Y5X1117
basic care tioconazoleTIOCONAZOLEAmazon.com Services LLC0484dbe9-37a6-4b98-b29a-3c006205c94d2024-12-18WarningsExact identifier
application number: ANDA075915
rxcui: 198380
unii: S57Y5X1117
Shea Butter Petroleum JellyPETROLATUM JELLYWalgreense35d913e-2195-4e3d-ae38-f010317140fd2024-12-17WarningsExact identifier
unii: 4T6H12BN9U
Jell Pharmaceuticals Vitamin A DPETROLATUMJell Pharmaceuticals Pvt. Ltd.6ab8ba54-3679-4fd0-a876-cb89aace96ca2024-12-17WarningsExact identifier
unii: 4T6H12BN9U
Shea Butter Petroleum JellyPETROLATUM JELLYJell Pharmaceuticals Pvt. Ltd.cd848f33-e863-d3af-e053-2a95a90a45b12024-12-17WarningsExact identifier
unii: 4T6H12BN9U
Recticare AdvancedLIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUMFerndale Laboratories, Inc.209212a7-7b6e-4b26-9f31-0eeb76f026bf2024-12-17WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIRugbya5b5e0a9-eee9-2a1e-e053-2a95a90a464e2024-12-17WarningsExact identifier
unii: 4T6H12BN9U
White PetrolatumPETROLATUMGeri-Care Pharmaceuticals, Corpf40a29c2-65ea-91f9-e053-2a95a90ac4392024-12-17WarningsExact identifier
unii: 4T6H12BN9U
Vitamin A and DPETROLATUMGeri-care Pharmaceutials Corpfd76c101-a287-f92c-e053-6294a90a44682024-12-17WarningsExact identifier
unii: 4T6H12BN9U
Systane NighttimeMINERAL OIL AND WHITE PETROLATUMAlcon Laboratories, Inc.4689c59c-5721-3f91-6c85-e41501998fd02024-12-05WarningsExact identifier
unii: 4T6H12BN9U
GenTeal Tears NIGHT-TIMEMINERAL OIL, WHITE PETROLATUMAlcon Laboratories, Inc.9d5998a7-4f59-4293-87da-8419650a524d2024-12-05WarningsExact identifier
unii: 4T6H12BN9U
PETROLEUM jellyPETROLATUMUniversal Distribution Center LLCeaaf95d7-df80-407e-b784-4e42a89d64e52024-12-04WarningsExact identifier
unii: 4T6H12BN9U
UNIVERSAL COCOA BUTTER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCec688073-6577-6cf9-e053-2a95a90a631d2024-12-04WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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