FDA.reportPublic FDA data

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Product NDC
30142-059
11-digit product format
301420059
Labeler code
30142
Product ID
30142-059_9902b6fe-db86-4b16-9302-c194c98aa97e
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
KROGER COMPANY
Application
ANDA209116
Marketing category
ANDA
Marketing start
2021-03-15
Substance
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
60; 120 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30

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.

Product history page 2 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FEXOFENADINE HYDROCHLORIDE60 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2S068B75ZUInternal UNII lookup
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
997406Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b8b2c45d-3aba-d98a-e053-2a95a90a879bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-059-20Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE104
30142-059-20Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride2 in 1 CARTONTABLET, FILM COATED, EXTENDED RE24
30142-059-84Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride3 in 1 CARTONTABLET, FILM COATED, EXTENDED RE34
30142-059-84Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-059FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [KROGER COMPANY]4Current NDC, Legacy NDC, 4 package rows20240613_b8b2c45d-3aba-d98a-e053-2a95a90a879b.zip

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 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC4726af84-83c1-456d-995c-f6a8d1583f8b2026-05-27WarningsExact identifier
application applno (ANDA): 209116
application number: ANDA209116
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN CO.1fcb601c-19d2-4db9-938b-b4f98ba9332f2024-06-26WarningsExact identifier
application applno (ANDA): 209116
application number: ANDA209116
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy, Inc.e9161bb2-190f-14b3-e053-2995a90a9b2f2024-06-01WarningsExact identifier
application applno (ANDA): 209116
application number: ANDA209116
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEKROGER COMPANYb8b2c45d-3aba-d98a-e053-2a95a90a879b2024-05-18WarningsExact identifier
application applno (ANDA): 209116
application number: ANDA209116
ndc (product): 30142-059
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECardinal Healthc3b40d04-7eef-4c80-a604-808d2be72ad72024-05-06WarningsExact identifier
application applno (ANDA): 209116
application number: ANDA209116
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDERugby Laboratoriescc6df813-9175-4c0b-a8e4-afcaa3aa833f2024-05-06WarningsExact identifier
application applno (ANDA): 209116
application number: ANDA209116

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997406fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNb8b2c45d-3aba-d98a-e053-2a95a90a879b4
99740612 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDb8b2c45d-3aba-d98a-e053-2a95a90a879b4
997406fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral TabletSYb8b2c45d-3aba-d98a-e053-2a95a90a879b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-059-20301420059202 BLISTER PACK in 1 CARTON (30142-059-20) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2024-05-18NoNoCurrent
30142-059-84301420059843 BLISTER PACK in 1 CARTON (30142-059-84) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK3 blister pack2021-03-150000-00-00NoNoCurrent