FDA.reportPublic FDA data

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 30 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM SULFACETAMIDE AND SULFURSODIUM SULFACETAMIDE, SULFURBioComp Pharma, Inc.61e1497d-40ff-0c87-e053-2991aa0a29432026-01-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE AND SULFURSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.02acb079-f3b3-49f2-b1d9-4fc1553f72a92026-01-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
ECHINACEAECHINACEA ANGUSTIFOLIA, HAMAMMELIS VIRGINIANA, CALCAREA PHOSPHORICA, HYDRASTIS CANADANESIS, SENEGA OFFICINALIS, SILICEA, CONIUM, AURUM MURIATICUM NATRONATUM, CALCAREA CARBONICA, FUCUS VESICULOSUS, LACHESIS MUTUSMarco Pharma International LLC.7efadb70-99e4-428b-a8ef-a2797327c6fa2026-01-12WarningsExact identifier
unii: ZW3Z11D0JV
ABCACONITUM NAPELLUS, BELLADONNA, CHAMOMILLAMARCO PHARMA INTERNATIONAL LLC44749e04-ca70-410d-a754-8befe8da11e72026-01-12WarningsExact identifier
unii: G0R4UBI2ZZ
AcusineHYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, EPHEDRA VULGARIS, MEZEREUM, PETROLEUM, PULSATILLA, THUJA OCCIDENTALISMarco Pharma International LLCd3edf95a-547c-79e4-e053-2a95a90a91b82026-01-12WarningsExact identifier
unii: ZW3Z11D0JV
unii: I76KB35JEV
LuffaLUFFA, HYDRASTIS CANADENSIS, MERCURIUS SULPH. RUB, ALLIUM CEPA, NATRUM MURITICUM, PHOSPHORUS, EUPATORIUM PERF, STICTAMarco Pharma International LLC.7dbb79de-c3f5-4245-884a-a6bd29bb861c2026-01-12WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: 492225Q21H
unii: ZW3Z11D0JV
ArtalgiaCARDUUS MARIANUS, ARNICA MONTANA, AGARICUS MUSCARIUS, BARYTA CARBONICA, BELLIS PERENNIS, GLONOINUM, HAMAMELIS VIRGINIANATodd Horton DPMc61841db-5a8f-4d36-93bb-19f6c05dd91e2026-01-12WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
Vascu-Pro T009CACTUS GRANDIFLORUS, HAMAMELIS VIRGINIANA, VALERIANA OFFICINALIS, ARTERIA SUIS, HEART (SUIS), ARNICA MONTANA, AURUM METALLICUM, BARYTA MURIATICA, CHOLESTERINUM, LECITHIN, MAGNESIA MURIATICA, OXALICUM ACIDUM, PHOSPHORUSGuangzhou Renuma Medical Systems Co., Ltd01d22fd6-7d2f-4448-81ff-c88baafc0af72026-01-09WarningsExact identifier
unii: 27YLU75U4W
Lung DrainageANTIMONIUM ARSENICICUM, BRYONIA (ALBA), CAMPHORA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CHININUM MURIATICUM, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HAEMOPHILUS INFLUENZAE B, IPECACUANHA, KALI MURIATICUM, LOBELIA PURPURESCENS, LUNG (SUIS), MYCOPLASMA PNEUMONIAE, MYCOPLASMA PNEUMONIAE DNA, OXYGENIUM, PHOSPHORUS, PNEUMOCOCCINUM, SENEGA OFFICINALIS, STANNUM METALLICUM, VERATRUM VIRIDEDeseret Biologicals, Inc.fd109172-46c3-444e-9fa0-124f785c3fb52026-01-09WarningsExact identifier
unii: 27YLU75U4W
YeastCalmSODIUM BORATE,CALENDULA OFFICINALIS FLOWERING TOP,CANDIDA ALBICANS,GOLDENSEALLaboratoires Boirdoncd384b93-b803-8810-e053-2a95a90acdf02026-01-09WarningsExact identifier
unii: ZW3Z11D0JV
ST MORIZ SUNCARE BODY SUNSCREEN SPF30SUNCARE BODY SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.48026f09-6d15-8fa6-e063-6294a90a17cb2026-01-09WarningsExact identifier
unii: PDC6A3C0OX
Bio Galium PhaseAPIS MELLIFICA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALTHA PALUSTRIS, CLEMATIS ERECTA, CORTISONE ACETICUM, ECHINACEA (ANGUSTIFOLIA), GAERTNER BACILLUS (BACH), GALIUM APARINE, HEDERA HELIX, JUNIPERUS COMMUNIS, NITRICUM ACIDUM, ONONIS SPINOSA, PHOSPHORUS, SEDUM ACRE, SEMPERVIVUM TECTORUM, THUJA OCCIDENTALIS, URTICA URENSDeseret Biologicals, Inc.902f38c5-b870-4313-9b0b-e69ca357d8442026-01-09WarningsExact identifier
unii: 27YLU75U4W
Animal Pathogens Nosode Combination 9419ANIMAL PATHOGENS NOSODE COMBINATIONProfessional Complementary Health Formulas43b6ae2d-c089-4b81-bd15-0c66a84bbdbf2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Livestock Nosode Combination 9413LIVESTOCK NOSODE COMBINATIONProfessional Complementary Health Formulasc8c8fd6f-c7be-45f5-9c29-84533b6c21e02026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Hepaticol Drops 5008HEPATICOL DROPSProfessional Complementary Health Formulas79ee9e37-7853-4560-a87d-cdaefb603bbb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Attention Deficit Mild Drops 2146ATTENTION DEFICIT MILD DROPSProfessional Complementary Health Formulas68a65713-da9c-4f13-bc84-e45344b9dc642026-01-08WarningsExact identifier
unii: 27YLU75U4W
Fungus Nosode Combination 9401FUNGUS NOSODE COMBINATIONProfessional Complementary Health Formulasf85fb1bb-a395-45b8-9926-f652919a38302026-01-08WarningsExact identifier
unii: 70FD1KFU70
Sulphur 7138SULPHURProfessional Complementary Health Formulasce520b78-adda-4343-91c0-80d29912db552026-01-08WarningsExact identifier
unii: 70FD1KFU70
RET Stomach 7001RET STOMACHProfessional Complementary Health Formulas086427e0-599e-4405-a996-d949023f9d902026-01-08WarningsExact identifier
unii: 70FD1KFU70
Wet Eczema Drops 2136WET ECZEMA DROPSProfessional Complementary Health Formulas28f08a29-9b1a-4579-a56f-4cab7cdcfcb62026-01-08WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q

Reported adverse events (FAERS/openFDA)#

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