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 22 of 59 · 1,169 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrate 2BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUANatural Creations, Inc1122605f-715e-4f12-9d9d-a20442f9cd452025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: B697894SGQ
Mucus and Sinus Mucus and Sinus Symptom ReliefBRYONIA ALBA, HYDRASTIS CANADENSIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA PRATENSIS, SILICEA, STANNUM METALLICUM, THUJA OCCIDENTALIS, ZINCUM GLUCONICUMTRP Company2a42c4a3-9486-9b29-e063-6294a90a7c702025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Natural Relief Cold and Flu Plus ZincALLIUM CEPA, ARSENICUM ALBUM, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, NATRUM MURIATICUM, NUX VOMICA, SILICEA, SULPHUR, ZINCUM GLUCONICUMTRP Company2a352cf2-48fb-4862-e063-6294a90a2eeb2025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Ring ReliefARNICA MONTANA - CALCIUM SULFIDE - HYPERICUM PERFORATUM - LYCOPODIUM CLAVATUM SPORE - MERCURIUS SOLUBILIS - SALICYLIC ACID - SILICON DIOXIDE - ALLYLTHIOUREA -TRP Companyaa2cd967-3c27-4afe-8751-7ea50ab629132025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Ring ReliefARNICA MONTANA, CALCIUM SULFIDE, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM SPORE, THIOSINAMINUM, MERCURIUS SOLUBILIS, SALICYLIC ACID, SILICON DIOXIDE, ALLYLTHIOUREATRP Company1c9c7944-31a9-4019-aad5-6b7f86084b532025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Ring Relief PM Nighttime FormulaARNICA MONTANA, CALCIUM SULFIDE, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM SPORE, THIOSINAMINUM, MERCURIUS SOLUBILIS, SALICYLIC ACID, SILICON DIOXIDE, ALLYLTHIOUREATRP Company92ef0dd1-84f9-086c-e053-2a95a90ac6472025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Swimmers Ear Complete ReliefCALCIUM SULFIDE, LOESELIA MEXICANA TOP, MERCURIUS SOLUBILIS, POTASSIUM CHLORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, VALERIANTRP Companya3425da3-ace9-05c2-e053-2995a90ab09f2025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
SudoGest Nasal DecongestantPSEUDOEPHEDRINE HCLMajor Pharmaceuticals5229f4b2-a194-46f8-a0bc-4510fbe520752025-12-15WarningsExact identifier
unii: 6V9V2RYJ8N
GERM HPAPIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDENatural Creations, Inc.15dc5391-0e6e-45d9-8ac7-142333a907162025-12-12WarningsExact identifier
unii: ETJ7Z6XBU4
GermasodeARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, ARSENICUM ALBUM, BELLADONNA, BERBERIS VULGARIS, BORRELIA, CHLAMYDIA, HYDRASTIS CANADENSIS, LACHESIS MUTUS, LYMPHOGRANULOMA, MERCURIUS SOLUBILIS, OOPHORINUM, PHOSPHORUS, PNEUMOCOCCINUM, PYROGENIUM, SILICEA TERRANatural Creations, Inccad24325-e658-4427-a2e7-f821f01111702025-12-12WarningsExact identifier
unii: ETJ7Z6XBU4
HEADACHE HPSILVER NITRATE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MELILOTUS OFFICINALIS TOP, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SPIGELIA ANTHELMIANatural Creations, Inc.c38b83f0-3918-4ef6-8dfd-48fe438e584a2025-12-12WarningsExact identifier
unii: ETJ7Z6XBU4
Cell WellCALCIUM CARBONICA,CALCIUM FLUORATUM,CALCIUM PHOSPHORICUM,CALCIUM SULPHURICUM,FERRUM PHOSPHORICUM,KALIUM MURIATICUM,KALIUM PHOSPHORICUM,KALIUM SULPHURICUM,MAGNESIUM CARBONICA,MAGNESIUM PHOSPHORICUM,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAJoyWell Co LLC592c1f48-21c8-4ff5-8818-046662c9effe2025-12-11WarningsExact identifier
unii: ETJ7Z6XBU4
DIZZINESS HPOYSTER SHELL CALCIUM CARBONATE CRUDE, CHENOPODIUM AMBROSIOIDES, ANAMIRTA COCCULUS SEED, CONIUM MACULATUM FLOWERING TOP, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PULSATILLA VULGARIS, SILICON DIOXIDENatural Creations, Inc.9701096b-5efa-4acd-9227-339ecedfd6722025-12-10WarningsExact identifier
unii: ETJ7Z6XBU4
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEKroger Companyac67476a-2888-53c4-0a10-7f73ac2580c52025-12-10WarningsExact identifier
application number: ANDA215434
rxcui: 997406
unii: 2S068B75ZU
unii: 6V9V2RYJ8N
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDERite Aid Corporation0834bda9-e793-ad67-7f71-d2ffce47e5fc2025-12-10WarningsExact identifier
application number: ANDA215434
rxcui: 997406
unii: 2S068B75ZU
unii: 6V9V2RYJ8N
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWalgreens Companydb671b6e-7233-8872-0227-6da62d6b65072025-12-10WarningsExact identifier
application number: ANDA215434
rxcui: 997406
unii: 2S068B75ZU
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
application number: ANDA215434
rxcui: 997406
unii: 2S068B75ZU
unii: 6V9V2RYJ8N
FOSTER AND THRIVE ALL DAY ALLERGY DCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLC796bea75-847a-40cd-892c-0905caae5c4e2025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N

Reported adverse events (FAERS/openFDA)#

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