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 152 of 160 · 3,181 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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.98d08917-2f1b-4dc7-e053-2a95a90a1ce02020-12-02WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
Dizzi-VABSINTHIUM, ACONITUM NAP., ANTIMON. TART., BELLADONNA, BRYONIA, CARBOLICUM ACIDUM, COLCHICUM, CONIUM, FERRUM METALLICUM, GELSEMIUM, GLONOINUM, HYOSCYAMUS, IPECAC., IRIS VERSICOLOR, LYCOPODIUM, NUX VOM., PETROLEUM, PHOSPHORUS, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, THERIDION, ZINGIBER, ECHINACEA, HYPERICUM, PASSIFLORA, VALERIANANewton Laboratories, Inc.987fa8d3-2ac8-5771-e053-2995a90adc2f2020-12-02WarningsExact identifier
unii: 27YLU75U4W
Dizzi-VABSINTHIUM, ACONITUM NAP., ANTIMON. TART., BELLADONNA, BRYONIA, CARBOLICUM ACIDUM, COLCHICUM, CONIUM, FERRUM METALLICUM, GELSEMIUM, GLONOINUM, HYOSCYAMUS, IPECAC., IRIS VERSICOLOR, LYCOPODIUM, NUX VOM., PETROLEUM, PHOSPHORUS, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, THERIDION, ZINGIBER, ECHINACEA, HYPERICUM, PASSIFLORA, VALERIANANewton Laboratories, Inc.98f91b6f-2bb8-f7f9-e053-2a95a90a03612020-12-02WarningsExact identifier
unii: 27YLU75U4W
Eczema - Skin CareANTIMON. CRUD., ARSENICUM ALB., BERBER. VULG., BOVISTA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTON, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULEX IRRITANS, PULSATILLA, RHUS TOXICODENDRON, SARSAPARILLA, SEPIA, SULPHUR IOD., ECHINACEA, RUMEX CRISP., TARAXACUM, URTICA UR.Newton Laboratories, Inc.98fb65dc-6c97-3b9d-e053-2995a90ade262020-12-02WarningsExact identifier
unii: I76KB35JEV
unii: 1MBW07J51Q
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.9aefc830-329c-5e35-e053-2a95a90a6ffe2020-11-30WarningsExact identifier
unii: 27YLU75U4W
unii: 2788Z9758H
unii: 451W47IQ8X
unii: 492225Q21H
unii: 70FD1KFU70
unii: I76KB35JEV
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.9af2d6f4-baa8-5da9-e053-2995a90a3dac2020-11-30WarningsExact identifier
unii: 27YLU75U4W
unii: 2788Z9758H
unii: 451W47IQ8X
unii: 492225Q21H
unii: 70FD1KFU70
unii: I76KB35JEV
Hair-ScalpAPIS MEL., ARSENICUM ALB., CALC. CARB., DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDRASTIS, HYDROFLUORICUM ACIDUM, KALI CARB., LYCOPODIUM, MEZEREUM, OLEANDER, PETROLEUM, PHOSPHORICUM AC., PHOSPHORUS, RHUS TOXICODENDRON, SELENIUM, SEPIA, SILICEA, SULPHUR, THUJA OCC.Newton Laboratories, Inc.9ab3b944-443c-74a1-e053-2a95a90aa0e52020-11-30WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: 70FD1KFU70
unii: 1MBW07J51Q
Sleep HPARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALISGrato Holdings, Inc.90e8553a-cfa9-4bb1-a398-3242a4e7456b2020-11-30WarningsExact identifier
unii: 3SW678MX72
DiarrheaPYROGENIUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, BRYONIA, CARBO VEG., CHAMOMILLA, CINCHONA, COLLINSONIA, COLOCYNTHIS, ELATERIUM, GELSEMIUM, IPECAC., IRIS VERSICOLOR, LYCOPODIUM, PODOPH. PELT., RAPHANUS, TABACUM, VACCINIUM, ZINGIBER, AESCULUS HIPP., JUGLANS REGIANewton Laboratories, Inc.9148cd61-528e-3475-e053-2a95a90a17622020-11-25WarningsExact identifier
unii: G0R4UBI2ZZ
Fatigue FighterACONITUM 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.9aa3c692-fbe0-debe-e053-2995a90add502020-11-25WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: I76KB35JEV
Eye CareACONITUM NAP., ALLIUM CEPA, ARSENICUM ALB., BRYONIA, CALENDULA, CHELIDONIUM MAJUS, CINERARIA, EUPHRASIA, GRAPHITES, LYCOPODIUM, MERC. CORROS., NUX VOM., PHOSPHORUS, PHYTOLACCA, PICRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SULPHUR, ECHINACEANewton Laboratories, Inc.924e15f1-92af-7fc9-e053-2995a90a1fcc2020-11-25WarningsExact identifier
unii: 27YLU75U4W
unii: 492225Q21H
unii: 70FD1KFU70
unii: I76KB35JEV
Eye CareACONITUM NAP., ALLIUM CEPA, ARSENICUM ALB., BRYONIA, CALENDULA, CHELIDONIUM MAJUS, CINERARIA, EUPHRASIA, GRAPHITES, LYCOPODIUM, MERC. CORROS., NUX VOM., PHOSPHORUS, PHYTOLACCA, PICRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SULPHUR, ECHINACEANewton Laboratories, Inc.924e562a-d9ae-5cae-e053-2995a90ace382020-11-25WarningsExact identifier
unii: 27YLU75U4W
unii: 492225Q21H
unii: 70FD1KFU70
unii: I76KB35JEV
Fatigue FighterACONITUM 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.9ab1c9ba-a90e-7f55-e053-2a95a90a94512020-11-25WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: I76KB35JEV
Feminine ComfortAGARICUS MUSC., ARSENICUM ALB., AUR. MET., BERBER. AQUI., CALADIUM SEGUINUM, CANDIDA ALBICANS, CANTHARIS, CONIUM, GRAPHITES, HELONIAS DIOICA, HYDRASTIS, KALI CARB., KREOSOTUM, LYCOPODIUM, MERC. VIV., MUREX PURPUREA, NAT. MUR., NITRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SEPIA, SULPHUR, TARENTULA HISPANA, THUJA OCC., ZINC. MET., APIS MEL., HAMAMELISNewton Laboratories, Inc.9ab4520d-1dd3-7b9f-e053-2a95a90a274f2020-11-25WarningsExact identifier
unii: 451W47IQ8X
unii: ZW3Z11D0JV
unii: 70FD1KFU70
unii: I76KB35JEV
Eczema - Skin CareANTIMON. CRUD., ARSENICUM ALB., BERBER. VULG., BOVISTA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTON, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULEX IRRITANS, PULSATILLA, RHUS TOXICODENDRON, SARSAPARILLA, SEPIA, SULPHUR IOD., ECHINACEA, RUMEX CRISP., TARAXACUM, URTICA UR.Newton Laboratories, Inc.91d5a49e-3994-39ec-e053-2a95a90ac6902020-11-25WarningsExact identifier
unii: I76KB35JEV
unii: 1MBW07J51Q
Aches - PainsACONITUM NAP., ARG. NIT., ARNICA, BRYONIA, COLCHICUM, GUAIACUM, HYPERICUM, KALMIA, PHOSPHORUS, PHYTOLACCA, PULSATILLA, RHUS TOXICODENDRON, RUTA, SARCOLACTICUM AC., STICTA, STRAMONIUM, HAMAMELIS, TARAXACUM,Newton Laboratories, Inc.7923c9ad-6078-f496-e053-2991aa0a15c42020-11-24WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
Accident - Injury RescueACONITUM NAP, ARNICA, BELLIS, CALENDULA, ECHINACEA, GELSEMIUM, HAMAMELIS, HYPERICUM, LEDUM, PHOSPHORUS, RHUS TOXICODENDRON, RUTA, STAPHYSAG., SYMPHYTUM, HYDRASTIS CANADENSIS.Newton Laboratories, Inc.785fd0ec-efe7-790e-e053-2991aa0afd912020-11-24WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
Aches - PainsACONITUM NAP., ARG. NIT., ARNICA, BRYONIA, COLCHICUM, GUAIACUM, HYPERICUM, KALMIA, PHOSPHORUS, PHYTOLACCA, PULSATILLA, RHUS TOXICODENDRON, RUTA, SARCOLACTICUM AC., STICTA, STRAMONIUM, HAMAMELIS, TARAXACUM,Newton Laboratories, Inc.7924792b-7464-576e-e053-2a91aa0abc2c2020-11-24WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
AcneANTIMON. CRUD., ARSENICUM ALB., AUR. MET., BERBER. AQUI., BOVISTA, CARBO VEG., CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDROCOTYLE, KALI BROM., KALI IOD., LEDUM, LYCOPODIUM, NUX VOM., SILICEA, SULPHUR IOD., ZINC. MET., ECHINACEA, JUGLANS REGIA, LAPPA, TARAXACUMNewton Laboratories, Inc.798c853c-16ab-8502-e053-2a91aa0a65322020-11-24WarningsExact identifier
unii: 1MBW07J51Q
AcneANTIMON. CRUD., ARSENICUM ALB., AUR. MET., BERBER. AQUI., BOVISTA, CARBO VEG., CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDROCOTYLE, KALI BROM., KALI IOD., LEDUM, LYCOPODIUM, NUX VOM., SILICEA, SULPHUR IOD., ZINC. MET., ECHINACEA, JUGLANS REGIA, LAPPA, TARAXACUMNewton Laboratories, Inc.798d5f34-819a-9895-e053-2991aa0a1d622020-11-24WarningsExact identifier
unii: 1MBW07J51Q

Reported adverse events (FAERS/openFDA)#

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