NDC 54973-3375-01 - 4 Kids Cold and Cough Nighttime

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
54973-3375
Requested NDC
54973-3375-01
Package NDCs from labels
54973-3375-1, 54973-3375-2, 54973-3375-3, 54973-3375-01
Manufacturer
Hyland's Consumer Health Inc. | Hyland's Inc.
Effective date
2025-02-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hyland's Naturals Kids Cold & Cough NighttimeHyland's Consumer Health Inc. | Hyland's Inc.2025-02-06HUMAN OTC DRUG LABEL
Hyland's Naturals Kids Cold 'n Cough Combo PackHyland’s Inc. | Hyland's Inc.2023-09-27HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3375-14 Kids Cold and Cough Nighttime1 in 1 CARTONLIQUID111
54973-3375-14 Kids Cold and Cough Nighttime118 mL in 1 BOTTLE, PLASTICLIQUID11811
54973-3375-24 Kids Cold and Cough Nighttime5 mL in 1 PACKETLIQUID511
54973-3375-34 Kids Cold and Cough Nighttime1 in 1 CARTONLIQUID111
54973-3375-34 Kids Cold and Cough Nighttime148 mL in 1 BOTTLE, PLASTICLIQUID14811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-33754 KIDS COLD AND COUGH NIGHTTIME (ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL) LIQUID [HYLAND'S CONSUMER HEALTH INC.]11Current NDC, Legacy NDC, 5 package rows20250209_71e93027-33c9-6147-e053-2a95a90aaa09.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 84 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergena Zone 9 Kids Grasses, Trees and WeedsECHINACEA, BAPTISIA TINCTORIA, HYDRASTIS CANADENSIS, MYRRHA, PHYTOLACCA DECANDRA, TRIGONELLA FOENUM-GRAECUM, ZONE 9 TREE, ZONE 9 WEED, ZONE 9 GRASSMeditrend, Inc. DBA Progena Professional Formulationsa08362df-9a6f-4f67-b013-2def9f53b9b42025-01-29WarningsExact identifier
unii: ZW3Z11D0JV
Allergena Zone 3 Kids Trees, Weeds and GrassesECHINACEA, BAPTISIA TINCTORIA, HYDRASTIS CANADENSIS, MYRRHA, PHYTOLACCA DECANDRA, TRIGONELLA FOENUM-GRAECUMMeditrend, Inc. DBA Progena Professional Formulationsf8e3b0ff-3dd3-4c97-acb0-6a41bf4667bb2025-01-29WarningsExact identifier
unii: ZW3Z11D0JV
Allergena Texas TreesECHINACEA,BAPTISIA TINCTORIA, HYDRASTIS CANADENSIS, MYRRHA, PHYTOLACCA DECANDRA, TRIGONELLA FOENUM-GRAECUM, TEXAS TREE, TEXAS WEED, TEXAS GRASSMeditrend, Inc. DBA Progena Professional Formulationsd1a88226-866b-4666-a5d7-c8bed99a70992025-01-29WarningsExact identifier
unii: ZW3Z11D0JV
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
unii: 451W47IQ8X
Hydrastis canadensisGOLDENSEALWashington Homeopathic Productsdeac4e46-21b0-23c2-e053-2a95a90a0e272025-01-28WarningsExact identifier
unii: ZW3Z11D0JV
Hydrastis canadensisGOLDENSEALWashington Homeopathic Productsdfdb1bfb-7f9c-734b-e053-2a95a90a636b2025-01-28WarningsExact identifier
unii: ZW3Z11D0JV
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: I76KB35JEV
WHP Sinus CongestionGOLDENSEAL - POTASSIUM DICHROMATE - PULSATILLA VULGARISWashington Homeopathic Products06820c5e-3317-58d3-e063-6294a90ad81e2025-01-28WarningsExact identifier
unii: ZW3Z11D0JV
unii: I76KB35JEV
WHP Stomach DisordersARSENIC TRIOXIDE - IPECAC - STRYCHNOS NUX-VOMICA - PULSATILLA VULGARIS - SULFURWashington Homeopathic Products06e54e78-9696-3e62-e063-6294a90a7b932025-01-28WarningsExact identifier
unii: 70FD1KFU70
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: G0R4UBI2ZZ
unii: I76KB35JEV
WHP SleeplessnessARSENIC TRIOXIDE - ARABIC COFFEE BEAN - LACHESIS MUTA VENOM - PASSIFLORA INCARNATA FLOWERING TOPWashington Homeopathic Products06d15d06-c7ef-8e85-e063-6294a90ab2a22025-01-28WarningsExact identifier
unii: 3SW678MX72
WHP HeadacheATROPA BELLADONNA - BRYONIA ALBA ROOT - SODIUM CHLORIDE - STRYCHNOS NUX-VOMICA SEEDWashington Homeopathic Products06d25564-4c7e-0b3a-e063-6294a90a38bf2025-01-28WarningsExact identifier
unii: 451W47IQ8X
WHP SmokingARABICA COFFEE BEAN - STRYCHNOS NUX-VOMICA SEED - DELPHINIUM STAPHISAGRIA SEEDWashington Homeopathic Products06d2bf97-d513-7c04-e063-6394a90af4ed2025-01-28WarningsExact identifier
unii: 3SW678MX72
WHP Hot FlashesLACHESIS MUTA VENOM - PULSATILLA VULGARIS - SEPIA OFFICINALIS JUICE - SULFURWashington Homeopathic Products06d5e51f-78ab-72c7-e063-6394a90a9ab12025-01-28WarningsExact identifier
unii: 70FD1KFU70
unii: I76KB35JEV
WHP FungusKEROSENE - SULFUR - THUJA OCCIDENTALIS LEAFYWashington Homeopathic Products06d446a8-2fc0-fea1-e063-6394a90a835e2025-01-28WarningsExact identifier
unii: 70FD1KFU70
WHP Hay FeverONION - ARSENIC TRIOXIDE - GELSEMIUM SEMPERVIRENS ROOT - STRYCHNOS NUX-VOMICA SEEDWashington Homeopathic Products06d4d93a-eb79-99a3-e063-6394a90a8ed72025-01-28WarningsExact identifier
unii: 492225Q21H
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: ZW3Z11D0JV
unii: G0R4UBI2ZZ
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: ZW3Z11D0JV
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: ZW3Z11D0JV
Allergena Zone 7 Trees, Weeds, and GrassesECHINACEA,BAPTISIA TINCTORIA, HYDRASTIS CANADENSIS, MYRRHA, PHYTOLACCA DECANDRA, TRIGONELLA FOENUM-GRAECUM, ZONE 7 TREE, ZONE 7 WEED, ZONE 7 GRASSMeditrend, Inc. DBA Progena Professional Formulations544d43e5-b15a-428d-8008-2b272aa7f7002025-01-28WarningsExact identifier
unii: ZW3Z11D0JV

Reported adverse events (FAERS/openFDA)#

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