FDA.reportPublic FDA data

NDC 55111-447-07 - Fexofenadine HCl and Pseudoephedrine HCI

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
55111-447
Requested NDC
55111-447-07
Package NDCs from labels
55111-447-07, 55111-447-35, 55111-447-14, 55111-447-31
Manufacturer
Dr. Reddy's Laboratories Limited
Effective date
2024-12-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fexofenadine HCl and Pseudoephedrine HCI - Dr. Reddy's Laboratories LimitedDr. Reddy's Laboratories Limited2024-12-19HUMAN OTC DRUG LABEL
Fexofenadine HCl and Pseudoephedrine HCI - CVS PharmacyCVS Pharmacy2024-10-28HUMAN OTC DRUG LABEL
Fexofenadine HCl and Pseudoephedrine HCI - HEBHEB2017-12-07HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-447-07Fexofenadine HCl and Pseudoephedrine HCI5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE57
55111-447-14Fexofenadine HCl and Pseudoephedrine HCI4 in 1 CARTONTABLET, EXTENDED RELEASE47
55111-447-31Fexofenadine HCl and Pseudoephedrine HCI6 in 1 CARTONTABLET, EXTENDED RELEASE67
55111-447-35Fexofenadine HCl and Pseudoephedrine HCI2 in 1 CARTONTABLET, EXTENDED RELEASE27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-447FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]7Current NDC, Legacy NDC, 4 package rows20241222_728632be-7e5c-2d06-4c95-bc8ecc9be2ec.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-447-07EA - Each55111-4474f58ccdb-d761-4c3b-bca7-2808bbe17d4d12022-06-06
55111-447-14EA - Each55111-4471597fd92-2bcd-4f33-bb6e-3f88105cea9e12015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]5

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 7 of 58 · 1,154 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ScrofularoforceRUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc.737cd410-0405-41b0-b7f2-29bb200378492026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
Allergy ReliefFEXOFENADINE HCLP & L Development, LLCa976ad95-33d2-49f5-bad5-e980bf7648792026-06-08WarningsExact identifier
unii: 2S068B75ZU
VAXBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,BioActive Nutritional, Inc.faa4a678-321a-4982-a5d4-01b713e6862d2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
VermexARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUMBioActive Nutritional, Inc.6be5fbcf-bb22-4b20-b65a-d943c516adf92026-06-04WarningsExact identifier
unii: ETJ7Z6XBU4
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: ETJ7Z6XBU4
Allegra Allergy 24 hourFEXOFENADINE HYDROCHLORIDESelect Consumer Group2de81a41-8488-7e39-e063-6294a90a394b2026-06-01WarningsExact identifier
unii: 2S068B75ZU
allergy relief-DCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDERite Aid Corporationfdf98201-661c-4b1e-97f6-265807d90f762026-05-27WarningsExact identifier
unii: 6V9V2RYJ8N
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC4726af84-83c1-456d-995c-f6a8d1583f8b2026-05-27WarningsExact identifier
rxcui: 997406
unii: 2S068B75ZU
unii: 6V9V2RYJ8N
Mucinex DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEReckitt Benckiser LLCd5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f2026-05-27WarningsExact identifier
unii: 6V9V2RYJ8N
Leader Mucus Relief DGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leader12971fb2-2314-4443-bf70-b7eb5859b1482026-05-26WarningsExact identifier
unii: 6V9V2RYJ8N
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: 1K09F3G675
Allergy ReliefFEXOFENADINE HYDROCHLORIDEGrocery Outlet, Inc.441ce66e-515a-d380-e063-6394a90aec7d2026-05-21WarningsExact identifier
unii: 2S068B75ZU
Allergy ReliefFEXOFENADINE HYDROCHLORIDENUVICARE LLC895de6e9-c5b6-42fe-b450-f5d8331ce2e32026-05-21WarningsExact identifier
unii: 2S068B75ZU
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
unii: ETJ7Z6XBU4
C07 STRONG LIGAMENTS AND JOINTSARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALEApex Energetics Inc.bccf8c83-a6cd-e58c-e053-2a95a90a43d72026-05-13WarningsExact identifier
unii: ETJ7Z6XBU4
Children AllergyFEXOFENADINE HCLH E Ba26c3515-4a24-4988-b9bb-813420b156302026-05-12WarningsExact identifier
unii: 2S068B75ZU
SudoGestPSEUDOEPHEDRINE HYDROCHLORIDEMajor Pharmaceuticals78faa497-6743-b85b-e053-2a91aa0ae8222026-05-12WarningsExact identifier
unii: 6V9V2RYJ8N
Mucinex DS 12HR COLD, FEVER and SINUSNAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDEReckitt Benckiser LLC4e7e6674-c1ce-ea61-e063-6294a90afe042026-05-12WarningsExact identifier
unii: 6V9V2RYJ8N

Reported adverse events (FAERS/openFDA)#

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