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 35 of 143 · 2,848 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47461ad3-a11e-2a11-e063-6294a90a0f8f2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Tusnel PediatricDEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division82f447f6-4f1b-4f56-9d7d-ea02adeea88c2025-12-31WarningsExact identifier
unii: 6V9V2RYJ8N
Tusnel DM PediatricDEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Divisiond915eab8-013e-4ce3-b358-0d531e5ca1ba2025-12-31WarningsExact identifier
unii: 6V9V2RYJ8N
Sei Bella CC Brightening Creme LightOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.6894b9d9-a5b5-4c98-e053-2991aa0a9ca22025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella CC Brightening Creme FairOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.6892952a-d032-30bf-e053-2a91aa0a3bba2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella CC Brightening Creme Medium TanOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.68a4e8b4-36cb-6306-e053-2a91aa0a6d252025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella CC Brightening Creme MediumOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.68a4ed34-f492-67a6-e053-2a91aa0a04282025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Daily UV Defense Broad-Spectrum SPF 25 SunscreenSUNSCREENMelaleuca Inc.1f1d1575-cf37-5d66-e063-6394a90ab2a32025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Sheer to Light 140 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.a13e5326-73c3-9fa8-e053-2a95a90aae9d2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Sheer to Light 20 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.a13e3f45-8e6f-6a3f-e053-2995a90a17d22025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Deep 550 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e31a82-0cd0-5a1a-e053-2991aa0a33f82025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Light to Medium 200 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e2dfaa-d173-e6a9-e053-2a91aa0a46632025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium 300 WTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e2e541-c583-0f12-e053-2991aa0a4ab22025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 500 WTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e30231-4fba-35d4-e053-2991aa0a33cb2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium 440 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e30255-5640-3b4a-e053-2991aa0ab3f72025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 450 WTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e30255-564f-3b4a-e053-2991aa0ab3f72025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium 320 CTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e2e541-c596-0f12-e053-2991aa0a4ab22025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Light to Medium 160 NTITANIUM DIOXIDE 5% AND ZINC OXIDE 5%Melaleuca Inc.68e20c57-7b30-4e96-e053-2991aa0aab3e2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
CONTROL CORRECTIVE TINTED MOISTURIZER SPF-30 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC8ac09149-f7e7-40a8-b306-98964d0cd6e32025-12-31WarningsExact identifier
unii: 15FIX9V2JP
blood sugarCALC PHOS, CARPINUS BETULUS, FLOS, FERRUM PHOS, KALI PHOS, NAT MUR, NAT SULPH, OLEA EUROPAEA, FLOS, SILICEA, SINAPIS ARVENSIS, FLOSSiddha Flower Essences, LLC90ecd62b-c4bc-4bc4-a409-219929a49edb2025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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