FDA.reportPublic FDA data

NDC 70677-1010-01 - 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
70677-1010
Requested NDC
70677-1010-01
Package NDCs from labels
70677-1010-1, 70677-1010-01
Manufacturer
Strategic Sourcing Services, LLC
Effective date
2025-12-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FEXOFENADINE HYDROCHLORIDE - Strategic Sourcing Services, LLCStrategic Sourcing Services, LLC2025-12-10HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1010-1Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride4 in 1 CARTONTABLET, EXTENDED RELEASE42
70677-1010-1Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1010FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES, LLC]1Current NDC, 2 package rows20230422_23fdb518-8dcc-3671-f116-ea8c7b0a6e08.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1010-1EA - Each70677-101057c6b6ac-e972-482c-b88e-65235fb4bdbb12023-09-05

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 59 · 1,169 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDE7-elevend5914c05-e8db-4c79-82d0-a279d13041182019-06-20WarningsExact identifier
unii: 2S068B75ZU
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEHEBd9b46ff2-8bde-47c0-bc63-b19dbe7e197b2019-05-29WarningsExact identifier
unii: 6V9V2RYJ8N
12 Hour Nasal DecongestantPSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy85955336-3f79-457d-822c-f8be019729d12019-05-23WarningsExact identifier
unii: 6V9V2RYJ8N
Fexofenadine HCLFEXOFENADINE HCLNorthStar RxLLC9c308a91-640d-441b-8fb5-acb5a415405e2019-04-30WarningsExact identifier
unii: 2S068B75ZU
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy3a3d11e5-ebbf-4356-8ae6-4e5656b5644c2019-04-10WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEChain Drug Consortium, LLCaec6412a-b62c-44c8-84f5-77f5fa4410282019-04-10WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESAM'S WEST INC5a885a10-7751-44f1-b2d9-a918f27604df2019-03-29WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEDISCOUNT DRUG MART7668ad20-1ca7-4d93-b3a3-03cfde141f862019-03-19WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESafeway Inc.01a5d9dd-f123-443b-b968-412c0aadaaa22019-03-14WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEChain Drug Marketing Association Inc.880d368f-0ce3-4993-b5b1-13bf013105162019-03-14WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc9a6ece8b-7036-4cad-aeb3-993ef4bf614f2019-03-14WarningsExact identifier
unii: 6V9V2RYJ8N
Fexofenadine HCLFEXOFENADINE HCLCamber Consumer Caree437655c-f1f3-4b58-89ba-bf22e416d3112019-03-06WarningsExact identifier
unii: 2S068B75ZU
Skin Klear Acne ReliefTRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLORHomeocare Laboratories65afbc20-611b-4bc4-a151-c633bec66a822018-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
Sinus ReliefASAFETIDA, ECHINACEA ANGUSTIFOLIA, CALCIUM SULFIDE, POTASSIUM DICHROMATE, LUFFA OPERCULATA WHOLE, SILICON DIOXIDE, SINUSITISINUMHomeocare Laboratories84483171-df92-47de-9203-ed02d64fb5fb2018-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
Hair-X Hair Loss ReliefCADMIUM SULFATE, GRAPHITE, PHOSPHORIC ACID, SILICON DIOXIDE, SELENIUM, THALLIUM, USTILAGO MAYDISHomeocare Laboratories00b62179-e03b-4972-902d-3a0c969b59bc2018-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
GUNA-SINUS NOSEALTHAEA OFFICINALIS LEAF - ASCORBIC ACID - BLACK CURRANT - CALCIUM SULFIDE - COPPER - ECHINACEA ANGUSTIFOLIA - GOLDENSEAL - LACHESIS MUTA VENOM - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR - POTASSIUM CARBONATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA - SUS SCROFA THYMUS - SUS SCROFA URINARY BLADDER -Guna spa36fef678-17c6-4d2a-a0f0-ddb298611f252018-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
GastrozenCOFFEA TOSTA, GLYCYRRHIZA, PHYTOLACCA, TARAXACUM, HYDRASTIS, ARSENICUM ALB, GELSEMIUM, MERC SOLUB, NITRICUM AC, NUX VOM, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, BROMIUM, CADMIUM SULPHURICUM, CINCHONA, CONIUM, HYDROGEN, IODIUM, LACHESIS, PULSATILLA, SILICEA, SULPHURICUM ACNatural Creations, Inc98dd756f-6774-47c3-bdfb-deff82fb801d2018-12-21WarningsExact identifier
unii: ETJ7Z6XBU4
Runny Nose CPALLIUM CEPA, CALC CARB, FERRUM PHOS, HEPAR SULPH CALC, LYCOPODIUM, MERC SOLUB, PULSATILLA, SILICEA, SULPHURNatural Creations, Inc868ec0ad-9344-4f94-b2c1-2abb48479b152018-12-21WarningsExact identifier
unii: ETJ7Z6XBU4
Mold AntigenALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, BOLETUS SAT, BOTRYTIS CINEREA, CLADOSPORIUM METANIGRUM, FUSARIUM OXYSPORUM, HELMINTHOSPORIUM, MUCOR MUECEDO, PULLULARIA PULLULANS, RHIZOPUS NIGRICANS, USTILAGO MAYDIS, ARSENICUM ALB, CANDIDA ALB, CARBO AN, LACHESIS, LYCOPODIUM, MERC SOLUB, NITRICUM AC, PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, THUJA OCCZorex Internationalff92e909-b5a7-417f-98a4-551f1576fd1e2018-12-21WarningsExact identifier
unii: ETJ7Z6XBU4
Nausea CPAETHUSA CYNAPIUM, ANTIMON TART, ARSENICUM ALB, CALC CARB, CHAMOMILLA, CINCHONA, COCCUS, CUPRUM MET, FERRUM MET, IPECAC, KREOSOTUM, LYCOPODIUM, PETROLEUM, PULSATILLA, SILICEA, SULPHURNatural Creations, Inc2746cde1-577b-41d6-9f22-93d8f1a2c2352018-12-21WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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