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 151 of 160 · 3,181 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ExhaustionACONITUM NAP., ADRENALINUM, ARALIA QUINQUEFOLIA, ARNICA, ARSENICUM ALB., BAPTISIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CINCHONA, IODIUM, KALI CARB., KALI IOD., LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, NAT. MUR., NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABAL, THYROIDINUM, ECHINACEA, GINGKO, PHYTOLACCA.Newton Laboratories, Inc.98fc56b6-afed-2cfd-e053-2995a90a59ae2020-12-03WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: I76KB35JEV
FearACONITUM NAP., ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., CYPRIPEDIUM, GELSEMIUM, IGNATIA, KALI CARB., LYCOPODIUM, NAT.MUR., PHOSPHORUS, SAMBUCUS NIG., SEPIA, STAPHYSAG., STRAMONIUM, TARENTULA HISPANA, THERIDION, PASSIFLORA, VALERIANANewton Laboratories, Inc.99485faf-aee1-6482-e053-2a95a90a498b2020-12-03WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
Female FemroidsHYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, ARSENICUM ALBUM, CALCAREA IODATA, CARBO ANIMALIS, CONIUM MACULATUM, GRAPHITES, HYDRASTIS CANADENSIS, IODIUM, KREOSOTUM, LACHESIS MUTUS, PHOSPHORUS, SABINA, SECALE CORNUTUM, SEPIA, SILICEA, THLASPI BURSA-PASTORIS, THUJA OCCIDENTALIS, THYROIDINUM, TRILLIUM PENDULUM, USTILAGO MAIDIS.Newton Laboratories, Inc.9a01acb9-1b2b-3a33-e053-2995a90adc922020-12-03WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9a61f1ae-d3a4-68d7-e053-2a95a90a43332020-12-03WarningsExact identifier
unii: 27YLU75U4W
unii: 2788Z9758H
unii: 451W47IQ8X
unii: 492225Q21H
unii: 70FD1KFU70
unii: I76KB35JEV
FungalCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.99487f4a-76f6-407b-e053-2a95a90acfd42020-12-03WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
G-InflammCHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, COLOCYNTHIS, GRAPHITES, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IPECACUANHA, KALI BICHROMICUM, KALI CARBONICUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, MAGNESIA PHOSPHORICA, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9a153c45-0142-5abb-e053-2995a90a71f52020-12-03WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: G0R4UBI2ZZ
unii: I76KB35JEV
unii: 1MBW07J51Q
GlaucoACONITUM NAPELLUS, AURUM METALLICUM, BELLADONNA, CAUSTICUM, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, NUX VOMICA, OSMIUM METALLICUM, PHOSPHORUS, PHYSOSTIGMA VENENOSUM, RHUS TOXICODENDRON, SPIGELIA ANTHELMIA.Newton Laboratories, Inc.9a6394e7-14ed-ced1-e053-2995a90aeb882020-12-03WarningsExact identifier
unii: 27YLU75U4W
Headache-MigraineELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC..Newton Laboratories, Inc.994a037b-7165-3a1e-e053-2a95a90ad7ff2020-12-03WarningsExact identifier
unii: 27YLU75U4W
unii: 3SW678MX72
Heavy Metal-Amalga DetoxALLIUM SATIVUM, ALUMINIUM METALLICUM, ARG. MET., AUR. MET., BARYTA CARB., BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, CADMIUM METALLICUM, CALC. FLUOR., CARBO VEG., CHELIDONIUM MAJUS, CINCHONA, COBALTUM MET., CUPRUM MET., GLYCYRRHIZA GLABRA, HYDROFLUORICUM ACIDUM, IRIS VERSICOLOR, MANGANUM METALLICUM, MERC. VIV., NICCOLUM METALLICUM, OSMIUM METALLICUM, PLATINUM MET., PLUMB. MET., STANNUM MET., STRONTIUM CARB., THALLIUM METALLICUM, TITANIUM METALLICUM, CARDUUS MAR., TARAXACUMNewton Laboratories, Inc.99d7d83b-85f8-a4bf-e053-2995a90a703f2020-12-03WarningsExact identifier
unii: 2788Z9758H
Herpes SoresARSENICUM ALB., BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CISTUS CANADENSIS, CONIUM, CROTON, DULCAMARA, GRAPHITES, KALI BIC., LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULSATILLA, RANUNC. BULB., RHUS TOXICODENDRON, SARSAPARILLA, SEPIA, SULPHUR, THUJA OCC., ECHINACEA, HYPERICUMNewton Laboratories, Inc.99d9133b-6eea-511c-e053-2a95a90a74cb2020-12-03WarningsExact identifier
unii: 70FD1KFU70
unii: I76KB35JEV
Acne - Cystic AcneECHINACEA, JUGLANS REGIA, LAPPA MAJOR, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, AURUM METALLICUM, BERBERIS AQUIFOLIUM, BOVISTA, CARBO VEGETABILIS, CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, LEDUM PALUSTRE, LYCOPDIUM CLAVATUM, NUX VOMICA, SULPHUR IODATUM, ZINCUM METALLICUM, SILICEANewton Laboratories, Inc92afe017-74c7-16c6-e053-2995a90a5c7d2020-12-02WarningsExact identifier
unii: 1MBW07J51Q
Appetite - Craving ControlCHAMOMILLA, PASSIFLORA, VALERIANA, ANACARDIUM, ANTIMON. CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJ., DIGITALIS, GRAPHITES, HUMULUS, IRIS VERS., KALI CARB., LYCOPODIUM, NAT. CARB., NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS TOX., SCUTELLARIA, SEPIA, STRAMONIUMNewton Laboratories, Inc.98cf5293-2a47-5e15-e053-2995a90a9c3b2020-12-02WarningsExact identifier
unii: G0R4UBI2ZZ
unii: I76KB35JEV
Bact-InECHINACEA, HYDRASTIS CANADENSIS, IRIS VERSICOLOR, URTICA URENS, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, HYDRASTIS CANADENSIS, IODIUM, LACHESIS MUTUS, NUX VOMICA, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, ANTHRACINUM, PYROGENIUMNewton Laboratories, Inc.9a9f61c8-1913-1e6d-e053-2a95a90a83562020-12-02WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: I76KB35JEV
Blad-RAPIS MEL., BERBER. VULG., BRYONIA, CANTHARIS, CINCHONA, EQUISETUM HYEMALE, FERRUM PHOSPHORICUM, GELSEMIUM, JUNIPERUS COM., PAREIRA, PHOSPHORUS, PLANTAGO, PULSATILLA, SABAL, TEREBINTHINA, UVA-URSI, ECHINACEA, HYDRASTIS, LAPPA, SOLIDAGONewton Laboratories, Inc.98cf954f-4b9e-c4ce-e053-2995a90a31d22020-12-02WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: I76KB35JEV
BronCareECHINACEA, LAPPA, RUMEX CRISP., ANTIMON. TART., ARSENICUM ALB., BRYONIA, CAMPHORA, CHELIDONIUM MAJ., CINCHONA, DROSERA, EUCALYPTUS, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, IPECAC., KALI BIC., KALI CARB., KALI IOD., LYCOPODIUM, MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOS., PULSATILLA, SAINGUINARIA, SPONGIA, STANNUM MET., TUSSILAGO FAR., VERBASCUM, INFLUENZINUMNewton Laboratories, Inc.98d0c6e4-5825-0361-e053-2a95a90aaddd2020-12-02WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
unii: 1MBW07J51Q
Breast Care - FibrocysticBUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUMNewton Laboratories, Inc.98d01128-9887-12ce-e053-2a95a90a73292020-12-02WarningsExact identifier
unii: 27YLU75U4W
unii: G0R4UBI2ZZ
unii: I76KB35JEV
Childbirth CareARNICA MONTANA, CAULOPHYLLUM THALICTROIDES, CIMICIFUGA RACEMOSA, GELSEMIUM SEMPERVIRENS, PULSATILLA.Newton Laboratories, Inc.9a9fd3fb-7142-4620-e053-2a95a90a5e302020-12-02WarningsExact identifier
unii: I76KB35JEV
Connec-TECHINACEA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, CALCAREA FLUORICA, CAPSICUM ANNUUM, CARDUUS MARIANUS, CINCHONA OFFICINALIS, IODIUM, KALI CARBONICUM, LACHESIS MUTUS, MAGNESIA CARBONICA, MERCURIUS VIVUS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORUS, PHYTOLACCA DECANDRA, SECALE CORNUTUM, THYMUS SERPYLLUM, THUJA OCCIDENTALIS, THYROIDINUM, VERBASCUM THAPSUS.Newton Laboratories, Inc.9a630923-1497-1fc8-e053-2995a90ad0012020-12-02WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
DiabaseCYNARA, ECHINACEA, IRIS VERS., THUJA OCC., URTICA UR., ARG. MET., ARSENICUM ALB., AUR. MET., BOVISTA, BRYONIA, CHELIDONIUM MAJ., CHIONANTHUS, GAULTHERIA, HELONIAS, IRIS VERS., LYCOPODIUM, NUX VOM., PHOS., RHUS TOX., SABAL, SYZYGIUMNewton Laboratories, Inc.9948bd7a-2ca2-272c-e053-2a95a90a4dc02020-12-02WarningsExact identifier
unii: 27YLU75U4W
Distress-Mood-SadnessANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGONewton Laboratories, Inc.98d0be75-9b50-1e15-e053-2995a90abf3b2020-12-02WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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