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 81 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nervousness - AnxietyPASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, AMBRA GRISEA, ANACARDIUM ORIENTALE, ARGENTUM NITRICUM, ASAFOETIDA, BRYONIA, CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, HYPERICUM PERFORATUM, IGNATIA AMARA, KALI PHOSPHORICUM, NUX VOMICA, SAMBUCUS NIGRA, STRYCHNINUM, THERIDION, VALERIANA OFFICINALIS.Newton Laboratories, Inc.9c5db752-11bb-01c0-e053-2a95a90aa7312025-02-07WarningsExact identifier
unii: 3SW678MX72
unii: G0R4UBI2ZZ
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.9c978687-b14b-46b1-e053-2995a90a13062025-02-07WarningsExact identifier
unii: 70FD1KFU70
Nervousness - AnxietyPASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, AMBRA GRISEA, ANACARDIUM ORIENTALE, ARGENTUM NITRICUM, ASAFOETIDA, BRYONIA, CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, HYPERICUM PERFORATUM, IGNATIA AMARA, KALI PHOSPHORICUM, NUX VOMICA, SAMBUCUS NIGRA, STRYCHNINUM, THERIDION, VALERIANA OFFICINALIS.Newton Laboratories, Inc.9c94ff3a-2451-3617-e053-2a95a90a7cb92025-02-07WarningsExact identifier
unii: 3SW678MX72
unii: G0R4UBI2ZZ
Panic ButtonACONITUM NAP., APIS MEL., ARNICA, ARSENICUM ALB., BELLADONNA, BELLIS, BRYONIA, CALENDULA, CHAMOMILLA, CISTUS CANADENSIS, FERRUM PHOSPHORICUM, HISTAMINUM HYDROCHLORICUM, HYPERICUM, IGNATIA, MEZEREUM, ORNITHOGALUM, PASSIFLORA, PHOSPHORUS, PRUNUS SPIN., RHUS TOXICODENDRON, SARCOLACTICUM AC., SULPHUR, VERATRUM ALB., VALERIANA.Newton Laboratories, Inc.9b308f64-ba16-8b4f-e053-2995a90ac3ec2025-02-07WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
Panic ButtonACONITUM NAP., APIS MEL., ARNICA, ARSENICUM ALB., BELLADONNA, BELLIS, BRYONIA, CALENDULA, CHAMOMILLA, CISTUS CANADENSIS, FERRUM PHOSPHORICUM, HISTAMINUM HYDROCHLORICUM, HYPERICUM, IGNATIA, MEZEREUM, ORNITHOGALUM, PASSIFLORA, PHOSPHORUS, PRUNUS SPIN., RHUS TOXICODENDRON, SARCOLACTICUM AC., SULPHUR, VERATRUM ALB., VALERIANA.Newton Laboratories, Inc.9b3f50f3-1397-da75-e053-2995a90a340c2025-02-07WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
Pollen-WeedsGINKGO BILOBA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ADRENALINUM , ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, ARTEMISIA VULGARIS, BAPTISIA TINCTORIA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, DIOSCOREA VILOSA, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, KALI IODATUM, LACHESIS MUTUS, LILIUM TIGRINUM,Newton Laboratories, Inc.9c9a4de7-2eb0-240c-e053-2995a90a8b232025-02-07WarningsExact identifier
unii: 492225Q21H
unii: ZW3Z11D0JV
unii: I76KB35JEV
Pollen-WeedsGINKGO BILOBA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ADRENALINUM , ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, ARTEMISIA VULGARIS, BAPTISIA TINCTORIA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, DIOSCOREA VILOSA, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, KALI IODATUM, LACHESIS MUTUS, LILIUM TIGRINUM,Newton Laboratories, Inc.9caafbca-c8f7-d898-e053-2995a90a357a2025-02-07WarningsExact identifier
unii: 492225Q21H
unii: ZW3Z11D0JV
unii: I76KB35JEV
Tyson 2.0 Mike Red Eye Drops For Dry High EyesGLYCERIN, NAPHAZOLINE HCLJbrands Pharma L.L.C.288e9c85-0562-89bf-e063-6394a90a110d2025-02-07WarningsExact identifier
unii: PDC6A3C0OX
Sodium Sulfacetamide, SulfurSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.c735ff03-c97c-430d-a37b-5b40cf29046a2025-02-06Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Appetite - Craving ControlANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA.Newton Laboratories, Inc.7964f0f7-7774-fac6-e053-2a91aa0a3e4a2025-02-06WarningsExact identifier
unii: G0R4UBI2ZZ
unii: I76KB35JEV
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.9dc307a2-4aa1-b02a-e053-2995a90a17882025-02-06WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: G0R4UBI2ZZ
unii: I76KB35JEV
Appetite - Craving ControlANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA.Newton Laboratories, Inc.79655acc-f059-e509-e053-2a91aa0ac4882025-02-06WarningsExact identifier
unii: G0R4UBI2ZZ
unii: I76KB35JEV
Cold 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.9b952b77-d172-1828-e053-2a95a90ab4f62025-02-06WarningsExact identifier
unii: 70FD1KFU70
unii: I76KB35JEV
Dairy-Grain-NightshadesIRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.Newton Laboratories, Inc.9ba83c60-35be-181a-e053-2a95a90a98952025-02-06WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
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.91d5dd26-ec17-3192-e053-2a95a90a20802025-02-06WarningsExact identifier
unii: I76KB35JEV
unii: 1MBW07J51Q
Ear Wax Build-UpELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATANewton Laboratories, Inc.9302b838-6003-ba6a-e053-2995a90aedd32025-02-06WarningsExact identifier
unii: I76KB35JEV
Fever - InfectionANTHRACINUM, INFLUENZA A VIRUS, INFLUENZA B VIRUS, PYROGENIUM, ACONITUM NAP., ANTIMON. TART., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHAMOMILLA, CINCHONA, EUPATORIUM PERF., FERRUM METALLICUM, GELSEMIUM, HEPAR SULPH.CALC., IODIUM, LACHESIS, MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALIX NIGRA, VERBASCUM, APIS MEL., ECHINACEA, HYDRASTISNewton Laboratories, Inc.8f023019-5c58-e0de-e053-2a95a90accfd2025-02-06WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: G0R4UBI2ZZ
unii: I76KB35JEV
unii: 1MBW07J51Q
Fever - InfectionANTHRACINUM, INFLUENZA A VIRUS, INFLUENZA B VIRUS, PYROGENIUM, ACONITUM NAP., ANTIMON. TART., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHAMOMILLA, CINCHONA, EUPATORIUM PERF., FERRUM METALLICUM, GELSEMIUM, HEPAR SULPH.CALC., IODIUM, LACHESIS, MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALIX NIGRA, VERBASCUM, APIS MEL., ECHINACEA, HYDRASTISNewton Laboratories, Inc.91e5f7cb-9055-4708-e053-2995a90abdfa2025-02-06WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: G0R4UBI2ZZ
unii: I76KB35JEV
unii: 1MBW07J51Q
Hangover HelpAGARICUS MUSC., ARSENICUM ALB., BISMUTHUM METALLICUM, BRYONIA, CAPSICUM, CARBO VEG., GLONOINUM, IPECAC., IRIS VERSICOLOR, LAUROCERASUS, LYCOPODIUM, MEZEREUM, NUX VOM., PULSATILLA, RANUNC. BULB. , THERIDION, VERATRUM ALB., ZINC. MET., ZINGIBER, CHAMOMILLA, PASSIFLORA, VALERIANANewton Laboratories, Inc.9bcce2ee-42c2-29cf-e053-2a95a90a36392025-02-06WarningsExact identifier
unii: G0R4UBI2ZZ
unii: I76KB35JEV
Heavy Metal 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.9bd05208-1d6e-ab85-e053-2a95a90af38e2025-02-06WarningsExact identifier
unii: 2788Z9758H

Reported adverse events (FAERS/openFDA)#

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