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 22 of 27 · 535 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Up and Up Healing Petrolatum Skin ProtectantPETROLATUMTARGET CORPORATIONf9b62cd9-94ec-26b4-e053-6394a90a82672024-10-14WarningsExact identifier
unii: 4T6H12BN9U
topcare hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMTopco Associates LLC5e13da07-48cf-40bc-bb11-fd891886cbea2024-10-14WarningsExact identifier
unii: 4T6H12BN9U
COCOA BUTTER PETROLEUM jellyPETROLATUMUniversal Distribution Center LLCc1b10d34-2905-4ad6-8f90-7f9800de2b462024-10-14WarningsExact identifier
unii: 4T6H12BN9U
Gentle STEPS vitamins A and D Diaper Rash and Skin ProtectantLANOLIN, PETROLATUMOld East Main CO.1d20d040-ed6c-4ce9-81a9-3bbf2fa4587d2024-10-11WarningsExact identifier
unii: 4T6H12BN9U
MedlineWHITE PETROLATUMMedline Industries, LPe1089e9a-ecaa-5c65-e053-2995a90a86992024-10-10WarningsExact identifier
unii: 4T6H12BN9U
hemorrhoidal maximum strength pain reliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMKroger Company3c8f90e2-fecf-4439-9faa-81a32ffe47532024-09-26WarningsExact identifier
unii: 4T6H12BN9U
equate hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWal-Mart Stores Inc5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d2024-09-26WarningsExact identifier
unii: 4T6H12BN9U
Soothe Night TimeWHITE PETROLATUM MINERAL OILBausch & Lomb Incorporated638d3c3f-9960-43da-956e-0e28c77f533e2024-09-24WarningsExact identifier
unii: 4T6H12BN9U
DABUR Vitamin A and DWHITE PETROLATUMDabur India Limited22cd44ef-4b02-604d-e063-6394a90a7a0a2024-09-23WarningsExact identifier
unii: 4T6H12BN9U
Walgreens Hemorrhoidal Pain ReliefGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Walgreense79ed7ae-0d06-2f88-e053-2995a90a1e352024-09-20WarningsExact identifier
unii: 4T6H12BN9U
Healing Cream 3ozPETROLATUMChina Ningbo Shangge Cosmetics Technology Corp.21bdbb13-cc64-b5d7-e063-6294a90ae3fd2024-09-11WarningsExact identifier
unii: 4T6H12BN9U
Healing Cream15ozPETROLATUMRejoice International Corp.21e4026c-d3da-e4f7-e063-6394a90aabed2024-09-11WarningsExact identifier
unii: 4T6H12BN9U
Baby Balm Stick 0.65ozPETROLATUM OINTMENTChina Ningbo Shangge Cosmetics Technology Corp.21c0b614-ea19-e98d-e063-6294a90ac44e2024-09-10WarningsExact identifier
unii: 4T6H12BN9U
Baby Balm Stick 0.65ozPETROLATUMRejoice International Corp.20cf3bb8-4ab8-2980-e063-6294a90ad6312024-08-29WarningsExact identifier
unii: 4T6H12BN9U
Healing Cream 3ozPETROLATUMRejoice International Corp.20c9b964-c9af-d63a-e063-6294a90ab9792024-08-28WarningsExact identifier
unii: 4T6H12BN9U
Meijer Baby Petroleum Jelly Skin Protectant Frag FreePETROLATUMMeijer Distribution0a0e6de8-b7c1-af7e-e063-6394a90a3ee22024-08-26WarningsExact identifier
unii: 4T6H12BN9U
Meijer Baby Petroleum Jelly Skin Protectant Fresh ScentPETROLATUMMeijer Distribution0a0e9b39-9ce1-e788-e063-6294a90abf0b2024-08-26WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLRite Aid Corporation8e1f223a-a3a0-4837-9847-2a3939fcc5952024-08-15WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBryant Ranch Prepack485fd02f-bfea-41d0-90a1-f12fcfeb2a152024-08-14WarningsExact identifier
unii: 4T6H12BN9U
tioconazole 1TIOCONAZOLECVS Pharmacy49ef74a9-9850-4427-8658-ee4dd9050ae02024-08-09WarningsExact identifier
application number: ANDA075915
rxcui: 198380
unii: S57Y5X1117

Reported adverse events (FAERS/openFDA)#

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