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 80 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VitalityECHINACEA, LAPPA MAJOR, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ADRENALINUM, ALOE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, BRYONIA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, DIGITALIS PURPUREA, FERRUM METALLICUM, GLONOINUM, HYDROCOTYLE ASIATICA, IODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, THUJA OCCIDENTALIS, THYROIDINUM, GLYCYRRHIZA GLABRANewton Laboratories, Inc.9d3a6b0e-a23f-9f2d-e053-2995a90a75cf2025-02-10WarningsExact identifier
unii: 2788Z9758H
unii: 451W47IQ8X
Rheumatic-Joint CareURICUM ACIDUM, ACONITUM NAP.,APIS MEL., ARNICA, ARSENICUM ALB, BELLADONNA,BENZOICUM ACIDUM, BRYONIA, CALC. CARB., CHAMOMILLA, CINCHONA, COLCHICUM, EUPATORIUM PERF., GAULTHERIAPROCUMBENS, GUAIACUM, IODIUM, KALI BIC, KALMIA,LEDUM, PULSATILLA, RHUS TOXICODENDRON, RUTA,SABINA, STRYCHNINUM, LAPPA, PHYTOLACCA, SYMPHYTUM,Newton Laboratories, Inc.9cae7d07-19f5-f661-e053-2995a90a944d2025-02-10WarningsExact identifier
unii: G0R4UBI2ZZ
unii: I76KB35JEV
PrimeGINKGO BILOBA, RUTA GRAVEOLENS, AGNUS CASTUS, ALLIUM SATIVUM, AMBRA GRISEA, ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARNICA MONTANA, ARSENICUM ALBUM, AVENA SATIVA, BAPTISIA TINCTORIA, BARYTA CARBONICA, BRYONIA, CANTHARIS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PULSATILLA, RUTA GRAVEOLENS, SABAL SERRULATA, SELENIUM METALLICUM, ZINCUM METALLICUM.Newton Laboratories, Inc.9b40f630-0b91-9816-e053-2a95a90a16ec2025-02-10WarningsExact identifier
unii: I76KB35JEV
Restless LegMYGALE, AGARICUS MUSC., CAUSTICUM, CINCHONA, CONIUM, CUPRUM MET., GELSEMIUM, HYOSCYAMUS, HYPERICUM, KALI CARB., MAG. CARB., MERC. VIV., NUX VOM., PLUMB. MET., RHUS TOXICODENDRON, SECALE, STRYCHNINUM, TARENTULA HISPANA, VALERIANA, VERBASCUM, ZINC. MET., CHAMOMILLA,PASSIFLORANewton Laboratories, Inc.9b2e2194-fda3-6837-e053-2995a90ac61a2025-02-10WarningsExact identifier
unii: G0R4UBI2ZZ
Restless LegMYGALE, AGARICUS MUSC., CAUSTICUM, CINCHONA, CONIUM, CUPRUM MET., GELSEMIUM, HYOSCYAMUS, HYPERICUM, KALI CARB., MAG. CARB., MERC. VIV., NUX VOM., PLUMB. MET., RHUS TOXICODENDRON, SECALE, STRYCHNINUM, TARENTULA HISPANA, VALERIANA, VERBASCUM, ZINC. MET., CHAMOMILLA,PASSIFLORANewton Laboratories, Inc.9b3f076e-7edd-ea51-e053-2a95a90abd9b2025-02-10WarningsExact identifier
unii: G0R4UBI2ZZ
Just In CaseACONITUM NAPELLUS, ARNICA MONTANA, BRYONIA, ECHINACEA, LEDUM PALUSTRE, ARSENICUM ALBUM, CENCHRIS CONTORTRIX, CROTALUS CASCAVELLA, CROTALUS HORRIDUS, LACHESIS MUTUS, MERCURIUS CORROSIVUS, NAJA TRIPUDIANS, PHOSPHORUS, TOXICOPHIS PUGNAX, VIPERA BERUS, ELAPS CORALLINUS, HELODERMA.Newton Laboratories, Inc.a035f2bf-2f5d-0a50-e053-2995a90a8d9c2025-02-10WarningsExact identifier
unii: 27YLU75U4W
Gas-IndigestionCHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, DAPHNE INDICA, IPECACUANHA, IRIS VERSICOLOR, KALI CARBONICUM, KREOSOTUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, MERCURIUS VIVUS, NUX VOMICA, PHOSPHORUS, PULSATILLA, SPIGELIA ANTHELMIA, SULPHUR, PYROGENIUMNewton Laboratories, Inc.9a125a53-39c2-d849-e053-2a95a90a98452025-02-10WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
unii: I76KB35JEV
Bestmade Natural Products BM105ACID PHOS, AGNUS CASTUS, CHINA OFF, DAMIANA, IKSHUGANDHA, USTILAGO, PHOSPHOROUSBestmade Natural Products2d8bc5e4-23c7-a3ec-e063-6394a90a280b2025-02-07WarningsExact identifier
unii: 27YLU75U4W
Bestmade Natural Products BM108CALC CAUST, CUPRUM MET, GINSENG, HYOSCYAMUS, KALI IOD, NUX VOM, PHOSPHORUSBestmade Natural Products2d8d2c46-6548-38c4-e063-6294a90a00752025-02-07WarningsExact identifier
unii: 27YLU75U4W
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.9c0cd92b-905d-f90f-e053-2995a90a47052025-02-07WarningsExact identifier
unii: 451W47IQ8X
unii: ZW3Z11D0JV
unii: I76KB35JEV
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.9c0d8c82-6c4f-a511-e053-2995a90a793f2025-02-07WarningsExact identifier
unii: 451W47IQ8X
unii: ZW3Z11D0JV
unii: I76KB35JEV
MenopauseELAPS CORALLINUS, AGNUS, ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CANTHARIS, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, CROTALUS HORRIDUS, DAMIANA, GLONOINUM, HELONIAS DIOICA, IGNATIA, KALI CARB., LACHESIS, NAJA, NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA, SANGUINARIA, SEPIA, ECHINACEA, VALERIANANewton Laboratories, Inc.9c4872fd-bfe5-2472-e053-2995a90a361f2025-02-07WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
MenopauseELAPS CORALLINUS, AGNUS, ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CANTHARIS, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, CROTALUS HORRIDUS, DAMIANA, GLONOINUM, HELONIAS DIOICA, IGNATIA, KALI CARB., LACHESIS, NAJA, NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA, SANGUINARIA, SEPIA, ECHINACEA, VALERIANANewton Laboratories, Inc.9c4718ef-86ac-7bb7-e053-2a95a90a56272025-02-07WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
Morning Sickness-NauseaCHAMOMILLA, HYDRASTIS CANADENSIS, IRIS VERSICOLOR, BISMUTHUM METALLICUM, BRYONIA, CIMICIFUGA RACEMOSA, GOSSYPIUM HERBACEUM, IPECACUANHA, KREOSOTUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, NUX VOMICA, PULSATILLA, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9c4a6bf8-5f48-96a8-e053-2a95a90a97572025-02-07WarningsExact identifier
unii: ZW3Z11D0JV
unii: G0R4UBI2ZZ
unii: I76KB35JEV
Menstrual - PMSANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, DIOSCOREA, FOLLICULINUM, GELSEMIUM, LACHESIS, LILIUM, LYCOPODIUM, MILLEFOLIUM, NUX VOM., PULSATILLA, SABINA, SECALE, SEPIA,THLASPI, VIBURNUM OP., ZINGIBER, ECHINACEA, VALERIANANewton Laboratories, Inc.9c496655-8a6a-47e2-e053-2a95a90a7f012025-02-07WarningsExact identifier
unii: I76KB35JEV
Motion SicknessECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ABSINTHIUM, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, BELLADONNA, BRYONIA, CARBOLICUM ACIDUM, COLCHICUM AUTUMNALE, CONIUM MACULATUM, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, GLONOINUM, HYOSCYAMUS NIGER, IPECACUANHA, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, NUX VOMICA, PETROLEUM, PHOSPHORUS, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, THERIDION, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9c5a4018-0231-e92b-e053-2995a90a40162025-02-07WarningsExact identifier
unii: 27YLU75U4W
Motion SicknessECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ABSINTHIUM, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, BELLADONNA, BRYONIA, CARBOLICUM ACIDUM, COLCHICUM AUTUMNALE, CONIUM MACULATUM, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, GLONOINUM, HYOSCYAMUS NIGER, IPECACUANHA, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, NUX VOMICA, PETROLEUM, PHOSPHORUS, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, THERIDION, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9c592084-9412-c00b-e053-2a95a90a57902025-02-07WarningsExact identifier
unii: 27YLU75U4W
Poison IvyXEROPHYLLUM ASPHODELOIDES, ACONITUM NAP., ANACARDIUM ORIENTALE, APIS MEL., BRYONIA, CANTHARIS, CROTON, GRAPHITES, GRINDELIA, MEZEREUM, NUX VOM., RANUNC. BULB., RHUS TOXICODENDRON, SARSAPARILLA, SULPHUR, ECHINACEA, RUMEX CRISP.,TARAXACUM, URTICA UR.Newton Laboratories, Inc.9c9999b9-8d48-67f7-e053-2995a90aac962025-02-07WarningsExact identifier
unii: 70FD1KFU70
Muscle EaseCHAMOMILLA, PHYTOLACCA DECANDRA, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, ARGENTUM NITRICUM, ARNICA MONTANA, BRYONIA, CHAMOMILLA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, EUPATORIUM PERFOLIATUM, HYPERICUM PERFORATUM, NUX VOMICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, STRAMONIUM, STRYCHNINUM.Newton Laboratories, Inc.9c5a4018-0230-e92b-e053-2995a90a40162025-02-07WarningsExact identifier
unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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