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 57 of 115 · 2,291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AN12 ANUS PREMIUM CLEANSERGLYCERIN, ALLANTOINBESTVALUE Co., Ltdd11b7443-2dfc-3e17-e053-2a95a90afb762025-01-31WarningsExact identifier
unii: PDC6A3C0OX
Bestmade Natural Products BM82CALC CARB, HELLIBOR, BRYONIA, CAUSTICUM, LYCOPODIUM, IODIUMBestmade Natural Products2d03e738-ae55-175c-e063-6394a90aed102025-01-31WarningsExact identifier
unii: T7J046YI2B
Bestmade Natural Products BM62AMMONIUM BENZOICUM, AURUM MUR, CALC ARS, CARDUUS MAR, CROTALUS HORRIDUS, MURIATIC ACID, NUX VOM, PHOSPHORUS, VIPERABestmade Natural Products2ce99cb7-fe9e-5da2-e063-6294a90afc4e2025-01-30WarningsExact identifier
unii: 27YLU75U4W
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM68PHOSPHORUS, ARG NIT, GELSEMIUM, NAT MUR, KALI BROM, BARYTA CARBBestmade Natural Products2cec9c90-2e61-f005-e063-6294a90a87532025-01-30WarningsExact identifier
unii: 27YLU75U4W
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.8ca76872-a187-4fd8-8daf-9ee351bdf3462025-01-28WarningsExact identifier
unii: 27YLU75U4W
unii: 2788Z9758H
WHP Colds and CoughACONITUM NAPELLUS - ARSENIC TRIOXIDE - BRYONIA ALBA ROOT - PULSATILLA VULGARIS - STRYCHNOS NUX-VOMICA SEEDWashington Homeopathic Products066df766-b1f5-83df-e063-6394a90aa5882025-01-28WarningsExact identifier
unii: T7J046YI2B
unii: I76KB35JEV
WHP Sinus CongestionGOLDENSEAL - POTASSIUM DICHROMATE - PULSATILLA VULGARISWashington Homeopathic Products06820c5e-3317-58d3-e063-6294a90ad81e2025-01-28WarningsExact identifier
unii: I76KB35JEV
WHP Stomach DisordersARSENIC TRIOXIDE - IPECAC - STRYCHNOS NUX-VOMICA - PULSATILLA VULGARIS - SULFURWashington Homeopathic Products06e54e78-9696-3e62-e063-6294a90a7b932025-01-28WarningsExact identifier
unii: 62I3C8233L
unii: I76KB35JEV
Bowel-Digestive CareECHINACEA, JUGLANS REGIA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, IRIS VERSICOLOR, KALI BICHROMICUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, RAPHANUS SATIVUS, RHUS TOXICODENDRON, TABACUM, VERBASCUM THAPSUS, ZINGIBER OFFICINALENewton Laboratories, Inc.9d60d399-6f63-5842-e053-2995a90a7cf72025-01-28WarningsExact identifier
unii: 27YLU75U4W
unii: T7J046YI2B
unii: I76KB35JEV
WHP Flu like SymptomsBRYONIA ALBA ROOT - GELSEMIUM SEMPERVIRENS ROOT - TOXICODENDRON PUBESCENS LEAF - ARSENIC TRIOXIDE STRYCHNOS - NUX-VOMICA SEEDWashington Homeopathic Products0670e4b8-34bc-5c31-e063-6394a90a67182025-01-28WarningsExact identifier
unii: T7J046YI2B
WHP HeadacheATROPA BELLADONNA - BRYONIA ALBA ROOT - SODIUM CHLORIDE - STRYCHNOS NUX-VOMICA SEEDWashington Homeopathic Products06d25564-4c7e-0b3a-e063-6294a90a38bf2025-01-28WarningsExact identifier
unii: T7J046YI2B
WHP Hot FlashesLACHESIS MUTA VENOM - PULSATILLA VULGARIS - SEPIA OFFICINALIS JUICE - SULFURWashington Homeopathic Products06d5e51f-78ab-72c7-e063-6394a90a9ab12025-01-28WarningsExact identifier
unii: I76KB35JEV
Tummy UpsetCHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ALOE, ANGELICA SINENSIS RADIX, ANTIMONIUM , ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, GRAPHITES, HYDRASTIS CANADENSIS, IPECACUANHA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MYRRHA, NATRUM CARBONICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9dc2da0a-0b3a-548e-e053-2995a90abe6d2025-01-28WarningsExact identifier
unii: 27YLU75U4W
unii: 62I3C8233L
unii: T7J046YI2B
unii: I76KB35JEV
SnifflesECHINACEA, ACONITUM NAPELLUS, ARALIA QUINQUEFOLIA, ARSENICUM ALBUM, BRYONIA, EUPHRASIA OFFICINALIS, GAULTHERIA PROCUMBENS, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALVIA OFFICINALIS, STICTA PULMONARIA, THUJA OCCIDENTALIS, VERBASCUM THAPSUS, SINUSITISINUM, INFLUENZINUMNewton Laboratories, Inc.9db425ca-f80d-46e9-e053-2a95a90addc42025-01-28WarningsExact identifier
unii: 27YLU75U4W
unii: T7J046YI2B
unii: I76KB35JEV
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d63b107-cd47-d9a5-e053-2a95a90a44932025-01-28WarningsExact identifier
unii: T7J046YI2B
Allergena FragranceALLERGENA FRAGRANCEMeditrend, Inc. DBA Progena Professional Formulationse3ab2f9f-f2a3-434a-b3b4-115ecd3d99b72025-01-28WarningsExact identifier
unii: 27YLU75U4W
Fever-InfectionCHAMOMILLA, ECHINACEA HYDRASTIS CANADENSIS, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAMPHORA, CINA, CINCHONA OFFICINALIS, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, IGNATIA AMARA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, SALIX NIGRA, VERATRUM VIRIDE, INFLUENZINUMNewton Laboratories, Inc.9d762268-8c30-8a86-e053-2a95a90a419c2025-01-27WarningsExact identifier
unii: 27YLU75U4W
unii: 91GQH8I5F7
unii: T7J046YI2B
unii: I76KB35JEV
unii: 1MBW07J51Q
DiarrheaAESCULUS HIPPOCASTANUM, JUGLANS REGIA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, ELATERIUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, RHEUM, SULPHUR, TABACUM, VACCINIUM MYRTILLUSNewton Laboratories, Inc.9d7322da-c2fb-0fc3-e053-2a95a90ac70b2025-01-27WarningsExact identifier
unii: 27YLU75U4W
unii: 62I3C8233L
unii: T7J046YI2B
SnifflesECHINACEA, ACONITUM NAPELLUS, ARALIA QUINQUEFOLIA, ARSENICUM ALBUM, BRYONIA, EUPHRASIA OFFICINALIS, GAULTHERIA PROCUMBENS, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALVIA OFFICINALIS, STICTA PULMONARIA, THUJA OCCIDENTALIS, VERBASCUM THAPSUS, SINUSITISINUM, INFLUENZINUMNewton Laboratories, Inc.9db1327c-6746-76cb-e053-2995a90a6e272025-01-27WarningsExact identifier
unii: 27YLU75U4W
unii: T7J046YI2B
unii: I76KB35JEV

Reported adverse events (FAERS/openFDA)#

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