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 8 of 58 · 1,154 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
unii: 1K09F3G675
Childrens AllergyFEXOFENADINE HCLCVS PHARMACY, INC4ab89e0a-d5aa-481b-8793-c940a27ebeb22026-05-11WarningsExact identifier
unii: 2S068B75ZU
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
Childrens AllergyFEXOFENADINE HCLFamily Dollar (FAMILY WELLNESS)f7114f9d-5708-497a-8390-a11a82c8d84f2026-05-06WarningsExact identifier
unii: 2S068B75ZU
Guaifenesin DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDERUGBY LABORATORIES, INC.997946e6-eff0-4c15-8694-020a19c2d3362026-05-06WarningsExact identifier
unii: 6V9V2RYJ8N
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, SILICEA, ZINCUM METALLICUM, PLATINUM METALLICUMEnergique, Inc.12786efd-df42-4321-bfdf-88f542d387bb2026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Childrens AllergyFEXOFENADINE HCLH E B3b6f4a4b-b1bd-4062-9e7f-571b836b15362026-05-06WarningsExact identifier
unii: 2S068B75ZU
Age Defiance Pro7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, CALCAREA CARBONICA, CONIUM MACULATUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYDROFLUORICUM ACIDUM, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, SILICEA, HUMAN GROWTH HORMONEEnergique, Inc.d528bdbe-fb75-4b13-9cbc-efa2177d74d82026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDEOHM LABORATORIES INC.1a1afa95-570d-456e-b436-a0fcfaf685172026-05-05WarningsExact identifier
unii: 2S068B75ZU
Brompheniramine maleate, pseudoephedrine hydrochloride,BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE,Eywa Pharma Inc8a4b2d13-d1c9-416f-95fd-f7d7b7970bb52026-05-05Warnings, Adverse reactionsExact identifier
unii: 6V9V2RYJ8N
Pollen HayfeverADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM IODATUM, MUGWORT POLLEN (ARTEMISIA VULGARIS), BELLIS PERENNIS, BRASSICA SPP, CHENOPODIUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, ALFALFA POLLEN (MEDICAGO SATIVA), PHLEUM PRATENSE, YELLOW DOCK POLLEN (RUMEX CRISPUS), SABADILLA, SILICEA, GOLDENROD POLLEN (SOLIDAGO CANADENSIS), DANDELION POLLEN (TARAXACUM OFFICINALE), RED CLOVER POLLEN (TRIFOLIUM PRATENSE), XANTHIUM STRUMARIUMNaturalCare00665933-176e-4f16-b6ee-b55217b8abb32026-05-05WarningsExact identifier
unii: ETJ7Z6XBU4
Childrens Allegra HivesFEXOFENADINE HCLChattem, Inc.ff50d9cd-d849-43e8-b32a-4dcde798d3eb2026-05-01WarningsExact identifier
unii: 2S068B75ZU
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Hydrate ICOFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.c0c8d350-0257-4484-acd8-f852350173db2026-04-30WarningsExact identifier
unii: ETJ7Z6XBU4
Allegra Allergy, Travel BASIXFEXOFENADINE HYDROCHLORIDELil' Drug Store Products, Incb82d993a-16ff-4037-a182-7010de8e1cdd2026-04-27WarningsExact identifier
unii: 2S068B75ZU
Allegra AllergyFEXOFENADINE HYDROCHLORIDENavajo Manufacturing Company Inc.e8a00fa1-79af-4ce6-885f-0ce12c5da8362026-04-22WarningsExact identifier
unii: 2S068B75ZU
HistanazPSEUDOEPHEDRINE HCL, PYRILAMINE MALEATECapital Pharmaceutical, LLC3e87d0f3-f16c-5972-e063-6294a90acc8a2026-04-22WarningsExact identifier
unii: 6V9V2RYJ8N
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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