FDA.reportPublic FDA data

NDC 71858-0010-04 - Tirosint

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
71858-0010
Requested NDC
71858-0010-04
Package NDCs from labels
71858-0010-4, 71858-0010-1, 71858-0010-2, 71858-0010-04
Manufacturer
IBSA Pharma Inc.
Effective date
2026-03-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tirosint - IBSA Pharma Inc.IBSA Pharma Inc.2026-03-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71858-0010-1Tirosint1 in 1 CARTONCAPSULE113
71858-0010-1Tirosint10 in 1 BLISTER PACKCAPSULE1013
71858-0010-2Tirosint3 in 1 CARTONCAPSULE313
71858-0010-2Tirosint10 in 1 BLISTER PACKCAPSULE1013
71858-0010-4Tirosint10 in 1 BLISTER PACKCAPSULE1013
71858-0010-4Tirosint3 in 1 CARTONCAPSULE313

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71858-0010TIROSINT (LEVOTHYROXINE SODIUM) CAPSULE [IBSA PHARMA INC.]11Current NDC, Legacy NDC, 6 package rows20241027_7a7ade79-0165-4e31-b84e-667416c00c7e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71858-0010-4EA - Each71858-00108f761cf5-7112-4857-b7b7-8b5c293cc31912018-12-13

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 28 of 36 · 719 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUMNuCarePharmaceuticals, Inc.2380859a-5b65-f88f-e063-6394a90aa4e22024-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
hemorrhoidal maximum strength pain reliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMKroger Company3c8f90e2-fecf-4439-9faa-81a32ffe47532024-09-26WarningsExact identifier
unii: PDC6A3C0OX
equate hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWal-Mart Stores Inc5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d2024-09-26WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Hemorrhoidal Pain ReliefGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Walgreense79ed7ae-0d06-2f88-e053-2995a90a1e352024-09-20WarningsExact identifier
unii: PDC6A3C0OX
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
unii: PDC6A3C0OX
Levothyroxine sodiumLEVOTHYROXINE SODIUMProficient Rx LPb4f8dfd0-b15a-4da5-a0d0-ad768e0b7ff82024-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack8f83fd60-5aa7-4e7f-a6e9-917e2c1abf272024-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Up and Up Hemorrhoid MAX STRENGTH14.4% GLYCERIN, 0.25% PHENYLEPHRINE HCL, 1% PRAMOXINE HCL, 15% PETROLATUMTarget Corporation867677b5-fd1d-449e-966e-1de0b5c98afb2024-08-08WarningsExact identifier
unii: PDC6A3C0OX
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackd79526e0-d327-4545-a50c-99678766d8172024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackc22af2e0-fb36-4645-a911-3d293af5bd882024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals,Inc.b1b8c5a4-8132-24d2-e053-2995a90a59ec2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMAurobindo Pharma Limitedc760d0cc-2245-4914-8c67-d536c41ac90f2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals,Inc.cba6bb77-2140-6cba-e053-2995a90aa1b62024-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Levothyroxine SodiumLEVOTHYROXINE SODIUMHikma Pharmaceuticals USA Inc.6279390b-ee61-4ef9-ac15-25537ca783c12024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Zenibell Snail IntensiveCreamGLYCERINMISOCOS97c19dca-237c-c968-e053-2a95a90aeae72024-07-05WarningsExact identifier
unii: PDC6A3C0OX
Zenibell Snail Intensive TonerGLYCERINMISOCOS97c1b556-824d-bef7-e053-2a95a90ae1f22024-07-05WarningsExact identifier
unii: PDC6A3C0OX
aewajin Derma HydrocellGLYCERINMISOCOS980fcaea-27ba-da49-e053-2995a90ad5062024-07-05WarningsExact identifier
unii: PDC6A3C0OX
aewajin Derma Hydrocell 24k Gold SerumGLYCERINMISOCOSa17b2c6e-9db8-bae4-e053-2a95a90adcf62024-07-05WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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