FDA.reportPublic FDA data

NDC 54973-4113-01 - Kids Cough and Mucus Daytime Grape Flavor

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
54973-4113
Requested NDC
54973-4113-01
Package NDCs from labels
54973-4113-1, 54973-4113-01
Manufacturer
Hyland's Consumer Health Inc. | Hyland's INC
Effective date
2024-04-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CITRIC ACID MONOHYDRATE - Hyland's Consumer Health Inc. | Hyland's INCHyland's Consumer Health Inc. | Hyland's INC2024-04-23HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4113-1Kids Cough and Mucus Daytime Grape Flavor1 in 1 CARTONLIQUID13
54973-4113-1Kids Cough and Mucus Daytime Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4113KIDS COUGH AND MUCUS DAYTIME GRAPE FLAVOR (BRYONIA ALBA ROOT,CALCIUM SULFIDE,PULSATILLA VULGARIS WHOLE,FERROSOFERRIC PHOSPHATE,PHOSPHORUS,ANTIMONY POTASSIUM TARTRATE,IPECAC,RUMEX CRISPUS ROOT) LIQUID [HYLAND'S CONSUMER HEALTH INC.]3Current NDC, Legacy NDC, 2 package rows20240425_e72c8fdb-2679-86b3-e053-2a95a90a6cdf.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 68 of 113 · 2,244 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM PHENYLACETATE AND SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEZydus Pharmaceuticals USA Inc.204e84a7-5440-4537-9e40-06eb56c415e92024-09-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA IODATA, FUCUS VESICULOSUS, IODIUM, LAPIS ALBUS, LEVOTHYROXINUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SELENIUM METALLICUM, SPONGIA TOSTA, THYROIDINUM (SUIS)Energique, Inc.2f04e425-7160-41a7-aa1e-934db54f17512024-09-30WarningsExact identifier
unii: I76KB35JEV
Lymphastat VECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, SAMBUCUS NIGRA, ACONITUM NAPELLUS, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LACHESIS MUTUS, RHUS TOX, PYROGENIUM, INFLUENZINUMEnergique, Inc.d22d399e-d2e3-4833-b59a-d841022cc02f2024-09-30WarningsExact identifier
unii: T7J046YI2B
Sodium Phenylacetate and sodium benzoateSODIUM PHENYLACETATE AND SODIUM BENZOATENavinta LLCfbc7bfe3-6faa-45a3-befb-9ad7963c05712024-09-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Trace Mineral CordALUMINUM, ANTIMONY, BARIUM, BERYLLIUM, BISMUTH, BORON, BROMINE, CALCIUM, CARBON, CERIUM, CESIUM, CHLORIDE, CHROMIUM, COBALT, COPPER, DYSPROSIUM, ERBIUM, EUROPIUM, FLUORIDE, GADOLINIUM, GALLIUM, GERMANIUM, GOLD, HAFNIUM, HOLMIUM, INDIUM, IODINE, IRIDIUM, IRON, LANTHANUM, LITHIUM, LUTETIUM, MAGNESIUM, MANGANESE, MOLYBDENUM, NEODYMIUM, NICKEL, NIOBIUM, OSMIUM, PALLADIUM, PHOSPHORUS, PLATINUM, POTASSIUM, PRASEODYMIUM, RHENIUM, RHODIUM, RUBIDIUM, RUTHENIUM, SAMARIUM, SCANDIUM, SELENIUM, SILICON, SILVEREnergique, Inc.7a34327c-39fe-403b-87a0-4f3bea36bb2a2024-09-27WarningsExact identifier
unii: 27YLU75U4W
Mold Mix AntigensARSENICUM ALBUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, ASPERGILLUS NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, TORULA CEREVISIAE, ALTERNARIA TENUIS NEES, MUCOR RACEMOSUS, CANDIDA KRUSEI, RHIZOPUS NIGRICANSBioActive Nutritional, Inc.574a90e8-3d26-4577-825d-a73e715237832024-09-27WarningsExact identifier
unii: 27YLU75U4W
hemorrhoidal maximum strength pain reliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMKroger Company3c8f90e2-fecf-4439-9faa-81a32ffe47532024-09-26WarningsExact identifier
unii: PDC6A3C0OX
equate hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWal-Mart Stores Inc5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d2024-09-26WarningsExact identifier
unii: PDC6A3C0OX
Healing SupportALLIUM SATIVUM, APIS MELLIFICA, ARGENTUM METALLICUM, CALCAREA FLUORICA, CALTHA PALUSTRIS, CLEMATIS ERECTA, ECHINACEA (ANGUSTIFOLIA), GALIUM APARINE, HEDERA HELIX, JUNIPERUS COMMUNIS, NITRICUM ACIDUM, ONONIS SPINOSA, PHOSPHORUS, PYROGENIUM, SEDUM ACRE, SEMPERVIVUM TECTORUM, THUJA OCCIDENTALIS, URTICA URENSDeseret Biologicals, Inc.7bac4747-df9c-4de7-8898-80218632c3412024-09-26WarningsExact identifier
unii: 27YLU75U4W
Female LiquescenceDIOSCOREA VILLOSA, GLYCYRRHIZA GLABRA, HAMAMELIS VIRGINIANA, RUBUS IDAEUS, VIBURNUM OPULUS, CAULOPHYLLUM THALICTROIDES, ESTRADIOL, OOPHORINUM (SUIS), PROGESTERONE, UTERUS (SUIS), HUMAN GROWTH HORMONE (HGH), IGNATIA AMARANutritional Specialties, Inc.afc50cd7-61e5-45a6-9195-46a98d3f38e12024-09-25WarningsExact identifier
unii: 2788Z9758H
Flu HPACONITUM NAPELLUS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENSEnergique, Inc.293a47b3-10b4-4f01-8549-9071014e28032024-09-24WarningsExact identifier
unii: 91GQH8I5F7
unii: T7J046YI2B
LymphaparECHINACEA (ANGUSTIFOLIA), LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM , KALI MURIATICUM, LACHESIS MUTUS, SILICEAEnergique, Inc.c746c111-7ebc-46c1-b11b-04271887df9c2024-09-23WarningsExact identifier
unii: 1MBW07J51Q
HP AxisARGENTUM NITRICUM, BERBERIS VULGARIS, IODIUM, KALI CARBONICUM, NATRUM MURIATICUM, ADRENALINUM, CORTISONE ACETICUM, DHEA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, MELATONIN, TESTOSTERONE, ARSENICUM ALBUM, PHOSPHORUS, PROTEUS (VULGARIS), SEPIA, SILICEA, ALLOXANUM, CORTICOTROPIN RELEASING HORMONE, ADRENOCORTICOTROPHIN, ALDOSTERONEDeseret Biologicals, Inc.402f5b05-c71e-4dba-bc2b-049aee42952a2024-09-23WarningsExact identifier
unii: 27YLU75U4W
NausiaARSENICUM ALBUM, BRYONIA (ALBA), CADMIUM SULPHURATUM, COCCULUS INDICUS, COLCHICUM AUTUMNALE, CONIUM MACULATUM, CYCLAMEN EUROPAEUM, EUPHORBIA COROLLATA, FERRUM METALLICUM, IPECACUANHA, IRIS VERSICOLOR, LAC DEFLORATUM, LACTICUM ACIDUM, NUX VOMICA, PETROLEUM, PULSATILLA (PRATENSIS), SEPIA, TABACUM, THERIDION, ZINGIBER OFFICINALEDeseret Biologicals, Inc.025ed334-29dd-4519-b9f6-cf560e73c2942024-09-23WarningsExact identifier
unii: 62I3C8233L
unii: T7J046YI2B
Walgreens Hemorrhoidal Pain ReliefGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Walgreense79ed7ae-0d06-2f88-e053-2995a90a1e352024-09-20WarningsExact identifier
unii: PDC6A3C0OX
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
unii: PDC6A3C0OX
Respiforce F-HPACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENSBioActive Nutritional, Inc.a507329a-acd6-4a1e-bf8a-0223339129e72024-09-12WarningsExact identifier
unii: 91GQH8I5F7
unii: T7J046YI2B
Respiforce B-HPCARBO VEGETABILIS, CUPRUM METALLICUM, DROSERA (ROTUNDIFOLIA), IPECACUANHA, LACHESIS MUTUS, LOBELIA INFLATA, PHOSPHORUS, PULSATILLA (VULGARIS), RUMEX CRISPUS, SPONGIA TOSTABioActive Nutritional, Inc.a8308fa0-e11f-45e0-b2bf-2bf1aed5d3672024-09-12WarningsExact identifier
unii: 27YLU75U4W
unii: 9N1RM2S62C
unii: 62I3C8233L
unii: I76KB35JEV
SinusforceECHINACEA (ANGUSTIFOLIA), NUX MOSCHATA, TRIGONELLA FOENUM GRAECUM, HYDRASTIS CANADENSIS, ARSENICUM ALBUM, KALI BICHROMICUM, MERCURIUS SULPHURATUS RUBER, PULSATILLA (VULGARIS), SEPIA, MERCURIUS SOLUBILISBioActive Nutritional, Inc.17ceb312-5d0a-4eb0-b1f2-daa6994e1e862024-09-12WarningsExact identifier
unii: I76KB35JEV
STOMAPLEXCARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA (CASSIA ANGUSTIFOLIA), STOMACH (BOVINE), ARSENICUM ALBUM, ATROPINUM SULPHURICUM, CARBO VEGETABILIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUSBioActive Nutritional, Inc.e1b69e9b-ab47-49f4-bd91-89c935533d672024-09-11WarningsExact identifier
unii: 27YLU75U4W

Reported adverse events (FAERS/openFDA)#

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