FDA.reportPublic FDA data

allergy and congestion relief

Product NDC
42507-724
11-digit product format
425070724
Labeler code
42507
Product ID
42507-724_e7de712c-d94e-45d5-9448-af643fa2e3be
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine sulfate, Loratadine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
HyVee Inc
Application
ANDA075989
Marketing category
ANDA
Marketing start
2010-10-26
Marketing end
0000-00-00
Substance
LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength
10 mg/1; mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42507-724DDiscontinued by firm2026-07-31
excluded packagepackage42507-72442507-724-22DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075989-001LORATADINE AND PSEUDOEPHEDRINE SULFATELORATADINE; PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-03-04

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075989-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-03-04a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
kirkland signature allerclear d 24 hrLORATADINE, PSEUDOEPHEDRINE SULFATECostco Wholesale Companyc5815ab0-cb32-41ce-9a17-1cd87a66cdde2026-06-24WarningsExact identifier
application applno (ANDA): 075989
application number: ANDA075989
Allergy Relief DLORATADINE, PSEUDOEPHEDRINE SULFATEWalgreen Company9952e0fb-b20e-4f9c-8be7-aa286e271fee2026-02-28WarningsExact identifier
application applno (ANDA): 075989
application number: ANDA075989
allergy dLORATADINE, PSEUDOEPHEDRINE SULFATEL. Perrigo Company512f8f46-5c62-470d-b14a-93b86ec34ce82025-10-03WarningsExact identifier
application applno (ANDA): 075989
application number: ANDA075989
allergy congestion reliefLORATADINE, PSEUDOEPHEDRINE SULFATEKroger Company2dde77f9-72c4-42b4-aaaa-0bc300dffc372024-02-27WarningsExact identifier
application applno (ANDA): 075989
application number: ANDA075989
topcare allergy and congestion reliefLORATADINE, PSEUDOEPHEDRINE SULFATETopco Associates LLC32945cd9-60d4-4dc0-96e6-9ed28ffce3fb2023-08-29WarningsExact identifier
application applno (ANDA): 075989
application number: ANDA075989

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42507-724-222026-01-20C16284748780-19d75b9cf-f269-f424-e053-dadaa90a57ceHy-Vee, Inc. Allergy & Congestion Relief Drug Facts
42507-724-222020-01-31C16284748780-19d75b9cf-f269-f424-e053-dadaa90a57ceHy-Vee, Inc. Allergy & Congestion Relief Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNALLERGY AND CONGESTION RELIEF NON DROWSY (PSEUDOEPHEDRINE SULFATE, LORATADINE) TABLET, FILM COATED [HYVEE INC]1
PSEUDOEPHEDRINE SULFATEACTIVE INGREDIENTY9DL7QPE6BALLERGY AND CONGESTION RELIEF NON DROWSY (PSEUDOEPHEDRINE SULFATE, LORATADINE) TABLET, FILM COATED [HYVEE INC]1
LORATADINEACTIVE MOIETY7AJO3BO7QNALLERGY AND CONGESTION RELIEF NON DROWSY (PSEUDOEPHEDRINE SULFATE, LORATADINE) TABLET, FILM COATED [HYVEE INC]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FALLERGY AND CONGESTION RELIEF NON DROWSY (PSEUDOEPHEDRINE SULFATE, LORATADINE) TABLET, FILM COATED [HYVEE INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALLERGY AND CONGESTION RELIEF NON DROWSY (PSEUDOEPHEDRINE SULFATE, LORATADINE) TABLET, FILM COATED [HYVEE INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY AND CONGESTION RELIEF NON DROWSY (PSEUDOEPHEDRINE SULFATE, LORATADINE) TABLET, FILM COATED [HYVEE INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY AND CONGESTION RELIEF NON DROWSY (PSEUDOEPHEDRINE SULFATE, LORATADINE) TABLET, FILM COATED [HYVEE INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY AND CONGESTION RELIEF NON DROWSY (PSEUDOEPHEDRINE SULFATE, LORATADINE) TABLET, FILM COATED [HYVEE INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY AND CONGESTION RELIEF NON DROWSY (PSEUDOEPHEDRINE SULFATE, LORATADINE) TABLET, FILM COATED [HYVEE INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42507-724ALLERGY AND CONGESTION RELIEF NON DROWSY (PSEUDOEPHEDRINE SULFATE, LORATADINE) TABLET, FILM COATED [HYVEE INC]1Legacy NDC20110829_e7de712c-d94e-45d5-9448-af643fa2e3be.zip