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 50 of 115 · 2,291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio Co Enzyme PhaseACONITICUM ACIDUM, CIS-, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ADRENALINUM, , ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, ASCORBICUM ACIDUM, BARIUM OXALSUCCINICUM, BETA VULGARIS, CERIUM OXALICUM, CITRICUM ACIDUM, CYSTEINUM, FUMARICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM PHOSPHORICUM, NADIDUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PANTOTHENIC ACID, PROTEUS (MORGANI), PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM,Deseret Biologicals, Inc.6edee6eb-0ec9-4d2a-9dc9-dc2a6503a6db2025-04-08WarningsExact identifier
unii: 1MBW07J51Q
Allerpoll HPALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, NUX VOMICA, PHOSPHORUS, PULSATILLA (VULGARIS), SOLIDAGO VIRGAUREA, SULPHURBioActive Nutritional, Inc.e991a50a-2af8-496d-8082-00f579eeaae62025-04-03WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
Jointforce A-HPAPIS MELLIFICA, BRYONIA (ALBA), CAUSTICUM, COLCHICUM AUTUMNALE, KALMIA LATIFOLIA, LEDUM PALUSTRE, PULSATILLA (VULGARIS), RHODODENDRON CHRYSANTHUM, RHUS TOXBioActive Nutritional, Inc.23a88257-d545-4d34-94c3-760fb2e915c02025-04-03WarningsExact identifier
unii: T7J046YI2B
unii: I76KB35JEV
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Respiforce AARNICA MONTANA, ASCLEPIAS TUBEROSA, ERIODICTYON CALIFORNICUM, EUCALYPTUS GLOBULUS, LOBELIA INFLATA, PLANTAGO MAJOR, TRIFOLIUM PRATENSE, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CARBO VEGETABILIS, GRINDELIA, KALI CARBONICUM, NATRUM SULPHURICUM, PULSATILLA,BioActive Nutritionale9360698-bffb-4c91-b019-22e1e56704ee2025-04-02WarningsExact identifier
unii: T7J046YI2B
unii: I76KB35JEV
Prostatone HPCLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (VULGARIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISBioActive Nutritional, Inc2ccf602f-734a-4b2d-8d89-c410293f9eb92025-04-02WarningsExact identifier
unii: I76KB35JEV
Kidneyforce-HPARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREABioActive Nutritional, Inc.0c0f0c0c-10c2-47eb-aad6-bbffb6e167992025-04-02WarningsExact identifier
unii: 27YLU75U4W
Alka-Seltzer Heartburn Relief Lemon LimeANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCcc21af24-9a5b-6831-e053-2a95a90a0af42025-04-01WarningsExact identifier
unii: 2968PHW8QP
ColdcalmONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE IONLaboratoires Boironaf4a4765-8255-44fb-821c-4345a2a45e2a2025-04-01WarningsExact identifier
unii: I76KB35JEV
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEAilex Pharmaceuticals, LLC329655ae-c3c0-46b2-a925-e49777f2076b2025-03-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
NauseaCalmANAMIRTA COCCULUS SEED, IPECAC, STRYCHNOS NUX-VOMICA SEED, TOBACCO LEAF, KEROSENEBoironc846971d-fcf8-2cf4-e053-2995a90aaec82025-03-21Exact identifier
unii: 62I3C8233L
RenotoxTRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM,BioActive Nutritional, Inc.f2b9cc0d-e146-47f7-b1b8-3e4d1cf6d0e92025-03-20WarningsExact identifier
unii: T7J046YI2B
RenotoxTRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM,BioActive Nutritional, Inc.2b691b17-296b-49d2-924e-c62522d4b9a72025-03-20WarningsExact identifier
unii: T7J046YI2B
Anxiety HPACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), STAPHYSAGRIA, STRAMONIUMEnergique, Inc.191393fa-5f36-43c0-a183-09258eef9bda2025-03-20WarningsExact identifier
unii: 27YLU75U4W
DrainparSOLIDAGO VIRGAUREA, TRIFOLIUM PRATENSE, PROPOLIS, HEPAR SUIS, KIDNEY (SUIS), LYMPH NODE (SUIS), BERBERIS VULGARIS, BRYONIA (ALBA), CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, NUX VOMICA, SARSAPARILLA (SMILAX REGELII), TARAXACUM OFFICINALEEnergique, Inc.c7a223f3-3ae4-41b3-82cd-2082539aedde2025-03-18WarningsExact identifier
unii: T7J046YI2B
ThroatCalmARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTEDLaboratoires Boiron94afc290-2d11-11e7-818d-424c583030312025-03-17WarningsExact identifier
unii: T7J046YI2B
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, INFLUENZINUM (2023-2024)Energique, Inc.c0ef1647-22f9-4cfa-a7e6-90c47c93dbde2025-03-11WarningsExact identifier
unii: T7J046YI2B
Alka-Seltzer Heartburn Relief Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCdc1641f8-54c2-0d86-e053-2995a90a1dce2025-03-11WarningsExact identifier
unii: 2968PHW8QP
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: OJ245FE5EU
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, INFLUENZINUM (2021-2022), LACHESIS MUTUS, RHUS TOX, PYROGENIUMEnergique, Inc.9ec6f663-5f15-4daf-a36b-49fbe1c53a6c2025-03-11WarningsExact identifier
unii: T7J046YI2B

Reported adverse events (FAERS/openFDA)#

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