FDA.reportPublic FDA data

NDC 70000-0677-01 - Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

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
70000-0677
Requested NDC
70000-0677-01
Package NDCs from labels
70000-0677-1, 70000-0677-2, 70000-0677-01
Manufacturer
Cardinal Health | Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2024-05-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FEXOFENADINE - Cardinal Health | Aurohealth LLC | Aurobindo Pharma LimitedCardinal Health | Aurohealth LLC | Aurobindo Pharma Limited2024-05-06Human OTC Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0677-1Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride2 in 1 CARTONTABLET, FILM COATED, EXTENDED RE21
70000-0677-1Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE101
70000-0677-2Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE101
70000-0677-2Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride3 in 1 CARTONTABLET, FILM COATED, EXTENDED RE31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0677FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]1Current NDC, 4 package rows20240613_c3b40d04-7eef-4c80-a604-808d2be72ad7.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 4 of 59 · 1,171 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HIVES RELIEFFEXOFENADINE HYDROCHLORIDEWalgreen Companya79edb5d-02d9-4c53-9509-c69fd61156862026-07-22WarningsExact identifier
unii: 2S068B75ZU
Fexofenadine HCLFEXOFENADINE HCLWalmart Inc.353323b7-67ce-7ce6-e063-6394a90a77d42026-07-21WarningsExact identifier
unii: 2S068B75ZU
Allergy ReliefFEXOFENADINE HYDROCHLORIDEKroger Company2718d6a2-0678-4703-9a5a-26b27d7539422026-07-20WarningsExact identifier
unii: 2S068B75ZU
equate allergy reliefFEXOFENADINE HYDROCHLORIDEWalmart Inc.852c8ad2-fc7d-4728-b2c6-f64b960fe2ab2026-07-18WarningsExact identifier
unii: 2S068B75ZU
LoHist DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.93c9ad4f-3376-48c2-8276-0375663acd012026-07-16WarningsExact identifier
unii: 6V9V2RYJ8N
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Curist Hives ReliefFEXOFENADINE HYDROCHLORIDE 180 MGLittle Pharma, Inc.04c75e93-b1f4-2546-e063-6394a90af0e12026-07-15WarningsExact identifier
unii: 2S068B75ZU
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEBluePoint Laboratoriesa86aebd0-937e-5d73-e053-2995a90a656a2026-07-13WarningsExact identifier
unii: 2S068B75ZU
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Limited864e3052-5787-bf11-9d17-11274ca2304f2026-07-09WarningsExact identifier
unii: 2S068B75ZU
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.b0121213-eae1-8429-9986-3b3b26f35e472026-07-09WarningsExact identifier
unii: 2S068B75ZU
Allergy ReliefFEXOFENADINE HCLFamily Dollar (FAMILY WELLNESS)9d33bc80-696c-4f21-b38d-2cad0c1f09ad2026-07-09WarningsExact identifier
unii: 2S068B75ZU
RUGBY ALLERGY RELIEF DFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDERugby Laboratories35f93439-eed1-40f4-a792-7527fbf3c19a2026-07-08WarningsExact identifier
rxcui: 997406
unii: 2S068B75ZU
unii: 6V9V2RYJ8N
Allergy ReliefFEXOFENADINE HYDROCHLORIDECVS PHARMACYc77ee2bb-dc95-d8c9-e053-2995a90a96022026-07-08WarningsExact identifier
unii: 2S068B75ZU
Allergy ReliefFEXOFENADINE HCLWALMART INC. (see also Equate)eb37cf76-49e2-4332-b449-1ce475556ef52026-07-08WarningsExact identifier
unii: 2S068B75ZU
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
Childrens AllergyFEXOFENADINE HYDROCHLORIDEH2-Pharma, LLC84988f6d-85b1-45dd-89be-0333acc6b1802026-06-25WarningsExact identifier
unii: 2S068B75ZU
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs58193632-2468-4159-b1a9-c24a489f199f2026-06-24WarningsExact identifier
unii: 2S068B75ZU

Reported adverse events (FAERS/openFDA)#

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