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 156 of 160 · 3,181 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ImucodeASTRAGALUS, HYDRASTIS, ADRENALINUM, THYROIDINUM, PITUITARUM POSTERIUM, ARSENICUM ALB, BAPTISIA, BARYTA CARB, BARYTA MUR, BROMIUM, CANDIDA ALB, CEANOTHUS, CHININUM SULPH, CONIUM, HEPAR SULPH CALC, IGNATIA, INDIUM, IODIUM, MERC SOLUB, PHYTOLACCA, SULPHURNatural Creations, Incbe30901c-0673-4af0-8128-83ed59ff04b12018-12-21WarningsExact identifier
unii: ZW3Z11D0JV
unii: 70FD1KFU70
unii: 1MBW07J51Q
Runny Nose CPALLIUM CEPA, CALC CARB, FERRUM PHOS, HEPAR SULPH CALC, LYCOPODIUM, MERC SOLUB, PULSATILLA, SILICEA, SULPHURNatural Creations, Inc868ec0ad-9344-4f94-b2c1-2abb48479b152018-12-21WarningsExact identifier
unii: 492225Q21H
unii: 70FD1KFU70
unii: I76KB35JEV
unii: 1MBW07J51Q
Mold AntigenALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, BOLETUS SAT, BOTRYTIS CINEREA, CLADOSPORIUM METANIGRUM, FUSARIUM OXYSPORUM, HELMINTHOSPORIUM, MUCOR MUECEDO, PULLULARIA PULLULANS, RHIZOPUS NIGRICANS, USTILAGO MAYDIS, ARSENICUM ALB, CANDIDA ALB, CARBO AN, LACHESIS, LYCOPODIUM, MERC SOLUB, NITRICUM AC, PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, THUJA OCCZorex Internationalff92e909-b5a7-417f-98a4-551f1576fd1e2018-12-21WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
Pulsatilla 200CPULSATILLANatural Creations, Inc9c403208-8eaa-4ead-aab6-563b56a8bf482018-12-21WarningsExact identifier
unii: I76KB35JEV
E.N.V.BELLADONNA, BERBERIS VULG, CARDUUS MAR, CHELIDONIUM MAJ, COLOCYNTHIS, DIOSCOREA, HYDRASTIS, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, PHOS, PULSATILLA, VERATRUM ALBZorex International838498ba-cab9-4e1b-a567-e7f1862b7fbb2018-12-21WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: I76KB35JEV
Sulphur 30CSULPHURNatural Creations, Inc32c0d686-0732-47b6-9c05-943651d2814f2018-12-21WarningsExact identifier
unii: 70FD1KFU70
GUNA-ALLERGY-PREVAMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT -Guna spaadae93c0-1de9-4e45-ab58-148171f0dc862018-12-21WarningsExact identifier
unii: 2968PHW8QP
unii: 70FD1KFU70
GUNA-RHINO NOSEAPIS MELLIFERA - ARALIA RACEMOSA ROOT - ASCORBIC ACID - BLACK CURRANT - COPPER - EUPHORBIA RESINIFERA RESIN - EUROPEAN ELDERBERRY - HELIANTHEMUM CANADENSE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - HUMAN INTERLEUKIN-10 (NONGLYCOSYLATED) - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - MELILOTUS - ONION - PLANTAGO MAJOR - ROSA CANINA FRUIT - SILVER NITRATE -Guna spa5baeb698-1735-4586-9984-2a2cb0da871a2018-12-21WarningsExact identifier
unii: 492225Q21H
GUNA-MALEADENOSINUM CICLOPHOSPHORICUM - MELATONIN - PHOSPHORUS - SUS SCROFA ADRENAL GLAND - SUS SCROFA HYPOTHALAMUS - SUS SCROFA PANCREAS - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - SUS SCROFA TESTICLE - SUS SCROFA THYMUS - THYROID - TURNERA DIFFUSA TOP -Guna spa176425c5-0be9-4cc2-be71-599d4d135f232018-12-21WarningsExact identifier
unii: 27YLU75U4W
GUNA-DERMOALDESLEUKIN - ARSENIC TRIOXIDE - ATROPA BELLADONNA - CANAKINUMAB - ECHINACEA ANGUSTIFOLIA - GRAPHITE - MELATONIN - PLANTAGO MAJOR - SOLANUM DULCAMARA FLOWER - SULFUR -Guna spa8bf717eb-fe46-4066-b124-eb715ffc15422018-12-21WarningsExact identifier
unii: 70FD1KFU70
GUNA-ORALACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - SUS SCROFA TOOTH - WITCH HAZEL -Guna spaf1b8e5ab-8689-4bf2-a6d9-863d02f295792018-12-21WarningsExact identifier
unii: 1MBW07J51Q
GUNA-PMSARSENIC TRIOXIDE - ESTRADIOL - GOLDENSEAL - LACHESIS MUTA VENOM - MAGNESIUM PHOSPHATE - MATRICARIA RECUTITA - MELATONIN - PROGESTERONE - STRYCHNOS NUX-VOMICA SEED - SULFUR - SUS SCROFA OVARY - SUS SCROFA PITUITARY GLAND -Guna spa86f341b1-a8f7-4833-a1be-e51610b05bcd2018-12-21WarningsExact identifier
unii: ZW3Z11D0JV
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
Fever CPACONITUM NAPELLUS, BRYONIA ALBA, CALCAREA CARBONICA, FERRUM PHOSPHORICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA, PYROGENIUM, SULPHURNatural Creations, Incae23ff31-b23b-469c-9960-6613df7692262018-12-21WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
unii: I76KB35JEV
Hemorrhoid GelACHILLEA MILLEFOLIUM, AESCULUS HIPPOCASTANUM, HAMAMELIS VIRGINIANA, RUSCUS ACULEATUS, ALOE SOCOTRINA, PAEONIA OFFICINALIS, IGNATIA AMARA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PEITATUM, PULSATILLA, RATANHIA, CHELIDONIUM MAJUS, SULPHURNatural Creations, Incd2016513-9b47-490d-9396-766db4cafecd2018-12-21WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
unii: I76KB35JEV
Weed Grass AntigenALOPECURUS PRATENSIS, ANTHOXANTHUM, CYNODON, MELILOTUS OFF, PHLEUM PRATENSE, RUMEX CRISP, SECALE CEREALE, SOLIDAGO, TRITICUM VULGARE, ALLIUM CEPA, AMBROSIA, ARSENICUM ALB, NUX VOMICA, PULSATILLANatural Creations, Inc8d54c1aa-7615-419c-825f-1fc534bda6082018-12-21WarningsExact identifier
unii: 492225Q21H
unii: I76KB35JEV
Vitality FemaleARALIA QUINQUEFOLIA, AVENA SATIVA, BERBERIS VULGARIS, CAUSTICUM, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIANatural Creations, Inc679ba86d-bf84-4ded-b0bf-d55a0df9faa42018-12-21WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
Nausea CPAETHUSA CYNAPIUM, ANTIMON TART, ARSENICUM ALB, CALC CARB, CHAMOMILLA, CINCHONA, COCCUS, CUPRUM MET, FERRUM MET, IPECAC, KREOSOTUM, LYCOPODIUM, PETROLEUM, PULSATILLA, SILICEA, SULPHURNatural Creations, Inc2746cde1-577b-41d6-9f22-93d8f1a2c2352018-12-21WarningsExact identifier
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
unii: I76KB35JEV
StressARALIA QUIN, PASSIFLORA, SCUTELLARIA, VALERIANA, ARSENICUM ALB, AUR MET, CALC CARB, COFFEA CRUDA, IGNATIA, KALI PHOS, LYCOPUS, PHOSPHORUS, STAPHYSAGRIAZorex Internationald0527396-7b7f-4252-be0f-d3aa74c25e0e2018-12-21WarningsExact identifier
unii: 27YLU75U4W
unii: 3SW678MX72
Hydrate IIBERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUAZorex Internationale5f53495-3b75-4d7c-89af-23058fb6fd052018-12-21WarningsExact identifier
unii: 2788Z9758H
unii: 451W47IQ8X
AllergyALLIUM CEPA, AMBROSIA, ARSENICUM ALB, CARBO VEG, EUPHRASIA, NUX VOM, PHOSPHORUS, PULSATILLA, SULPHUR, SOLIDAGOZorex International4718c012-b90d-4d7a-a97c-1abec1fd38342018-12-21WarningsExact identifier
unii: 27YLU75U4W
unii: 492225Q21H
unii: 70FD1KFU70
unii: I76KB35JEV

Reported adverse events (FAERS/openFDA)#

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