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 57 of 143 · 2,848 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31188175-a4ca-449f-e063-6394a90a3c052025-12-10WarningsExact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral Foaming SunscreenTITANIUM DIOXIDE, ZINC OXIDERestore Skin Therapy, LLC364b6af2-a0ed-4a17-e063-6394a90a3a172025-12-10Exact identifier
unii: 15FIX9V2JP
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b2403-4f4a-3e77-e063-6294a90a4f0a2025-12-10Exact identifier
unii: 15FIX9V2JP
Sheer Mineral Sunscreen BarTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b69d5-f0e1-99cd-e063-6294a90abb6e2025-12-10Exact identifier
unii: 15FIX9V2JP
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342c3f42-c17f-f777-e063-6394a90a80582025-12-10Exact identifier
unii: 15FIX9V2JP
Lip SPFTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396d3fdd-99d8-77e8-e063-6294a90aec2f2025-12-10Exact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396cae82-7641-e1b2-e063-6394a90a7c072025-12-10Exact identifier
unii: 15FIX9V2JP
Solar Knight SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDEMASCARENAS ENTERPRISES, INC.36c27c91-22ac-205c-e063-6294a90ab3792025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396ce15a-06ad-4055-e063-6294a90a27fb2025-12-10Exact identifier
unii: 15FIX9V2JP
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDERite Aid Corporation0834bda9-e793-ad67-7f71-d2ffce47e5fc2025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWalgreens Companydb671b6e-7233-8872-0227-6da62d6b65072025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N
Mucus Relief DGUAIFENESIN AND PSEUDOEPHEDRINE HCLCVS Health Corp19cde6f8-649a-df69-7ee9-05da2cccba5b2025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWal-mart Stores, Inc.a0ce5002-08e3-c21f-9b88-f3dd27dc9dda2025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N
FOSTER AND THRIVE ALL DAY ALLERGY DCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLC796bea75-847a-40cd-892c-0905caae5c4e2025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N
Mucus Relief DGUAIFENESIN AND PSEUDOEPHEDRINE HCLRite Aid Corporation82654829-a2a5-06aa-930c-5bdd60e49b102025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N
Mucus Relief DGUAIFENESIN AND PSEUDOEPHEDRINE HCLWalgreens Company01047716-389b-df25-ebe6-c897fc47d3df2025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLRite Aid Corporation9fb0c938-d24b-2371-95db-6c82d9511d722025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLStrategic Sourcing Services, LLC51ec068b-e219-381a-384b-a208a306d5ba2025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N
Mucus DGUAIFENESIN 600 MG AND PSEUDOEPHEDRINE HCL 60 MGCVS Health Corp284bbf6a-8b34-09b6-3115-553a9ec831222025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services, LLC23fdb518-8dcc-3671-f116-ea8c7b0a6e082025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N

Reported adverse events (FAERS/openFDA)#

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