FDA.reportPublic FDA data

NDC 70000-0475-01 - leader 12 hour nasal decongestant

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
70000-0475
Requested NDC
70000-0475-01
Package NDCs from labels
70000-0475-1, 70000-0475-01
Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2026-02-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
leader 12 hour nasal decongestant - Cardinal Health 110, LLC. dba LeaderCardinal Health 110, LLC. dba Leader2026-02-25HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0475-1leader 12 hour nasal decongestant1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE14
70000-0475-1leader 12 hour nasal decongestant10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0475LEADER 12 HOUR NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]3Current NDC, Legacy NDC, 2 package rows20210620_8b8d374c-592e-44fc-a6cc-9f9e73ef914c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0475-1EA - Each70000-04756c4ae1c1-8091-4105-a9c1-516082517e1b12020-01-03

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 146 · 2,909 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEShiseido Americas Corporationb93f10dc-193d-4cda-94b6-3f0e54d89f212026-02-23WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO ULTIMATE SUN PROTECTOR MINERALTITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION5e31eee8-6532-47ea-99fc-22418791804b2026-02-23WarningsExact identifier
unii: 15FIX9V2JP
Allergy Maximum StrengthURTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature122ca23e-43f1-4e5c-afc2-1418b17176792026-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b47e7cb-17d6-6a7c-e063-6294a90abbea2026-02-20WarningsExact identifier
unii: 15FIX9V2JP
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
unii: 15FIX9V2JP
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
unii: 15FIX9V2JP
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: ETJ7Z6XBU4
sinus and nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe39daa3c-1901-4966-b85e-ab76d7bd12162026-02-17WarningsExact identifier
application number: ANDA075153
rxcui: 1049154
unii: 6V9V2RYJ8N
BIO COM 25 ACIDITYNAT PHOS, NAT SULPH, SILICEABM Private Limited3b3c3455-b321-071d-e063-6394a90a01602026-02-17WarningsExact identifier
unii: ETJ7Z6XBU4
ALLERGY RELIEF D12CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5b6cd5ba-bdca-434e-b024-0089aeeec6a12026-02-17WarningsExact identifier
unii: 6V9V2RYJ8N
CINAAMBROSIA, CINA, CUCURBITA CIT, CUCURBITA PEP, INDIGO, SANTONINE, SILICEABM PRIVATE LIMITED3b3c0874-90b5-deda-e063-6394a90a78022026-02-15WarningsExact identifier
unii: ETJ7Z6XBU4
Acne/Pimple ControlCALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDEForces of Naturee871e46e-463e-49ec-a2af-5aa98548ee122026-02-13WarningsExact identifier
unii: ETJ7Z6XBU4
FuligoCIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEABM Private Limited3b27225f-4587-d915-e063-6294a90a72252026-02-12WarningsExact identifier
unii: ETJ7Z6XBU4
FOSTER AND THRIVE ALLERGY AND CONGESTION DFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLC945fcda4-0dd8-43cf-a5dd-ecea7995330a2026-02-11WarningsExact identifier
unii: 6V9V2RYJ8N
equate sinus 12 hourPSEUDOEPHEDRINE HYDROCHLORIDEWal-Mart Stores Incde65b99e-85e9-46c1-88b2-727c7ed8882a2026-02-11WarningsExact identifier
application number: ANDA075153
rxcui: 1049154
unii: 6V9V2RYJ8N
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
unii: 15FIX9V2JP
Mold, Yeast and DustADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEANaturalCare32afa0f0-bca5-4246-bc2e-decd757fcf9d2026-02-09WarningsExact identifier
unii: ETJ7Z6XBU4
mucus relief dGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEWalgreen Company440c0cf6-d63d-4523-b137-26f70adb977a2026-02-07WarningsExact identifier
unii: 6V9V2RYJ8N
foster and thrive mucus relief dGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLC235a465c-3a5e-4775-92e9-e57fd8d9c9b42026-02-07WarningsExact identifier
unii: 6V9V2RYJ8N
Hampton Sun SPF 50 MineralZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCd6c33436-042e-44e8-8b55-98be6e2468792026-02-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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