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 138 of 160 · 3,195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4 Kids Cold and Mucus NighttimeEUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFURHyland's Inc.6f7b2585-2f0e-5938-e053-2a91aa0aa9d12022-11-21WarningsExact identifier
unii: 27YLU75U4W
unii: 3SW678MX72
unii: 451W47IQ8X
unii: 492225Q21H
unii: ZW3Z11D0JV
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
unii: I76KB35JEV
unii: 1MBW07J51Q
4 Kids Complete Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.ef39fe3d-a42d-4baa-9199-91f664feb4322022-11-21WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: I76KB35JEV
unii: 1MBW07J51Q
GUNA-ARTHRO.ALPHA.-KETOGLUTARIC ACID - ALPHA LIPOIC ACID - ASCORBIC ACID - BARIUM OXALOSUCCINATE - BLACK COHOSH - BRYONIA ALBA ROOT - CALCITONIN HUMAN - CHLORINE - COLCHICUM AUTUMNALE BULB - NADIDE -Guna spa45ad3f03-0ee8-438f-81e7-3ca772022c982022-11-15WarningsExact identifier
unii: 70FD1KFU70
GUNA-LYMPHOAPIS MELLIFERA - CALENDULA OFFICINALIS FLOWER - CENTELLA ASIATICA - DODECAHYDROXYCYCLOHEXANE DIHYDRATE - EQUISETUM HYEMALE - FUMARIC ACID - GOLDENSEAL - GRAPHITE - JUGLANS REGIA LEAF - LEVOTHYROXINE - MAGNESIUM PHOSPHATE - MALIC ACID - MYOSOTIS ARVENSIS - PHYTOLACCA AMERICANA ROOT - SARSAPARILLA - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SUS SCROFA CAPILLARY TISSUE - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA VEIN - TARAXACUM OFFICINALE -Guna spaecd11761-9b9c-4d42-9e2b-f03ba4fed8ae2022-11-14WarningsExact identifier
unii: ZW3Z11D0JV
Multiple Electrolytes pH 7.4SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEFresenius Kabi USA, LLC84221110-b3f1-42f4-800c-ad1d3b330e9e2022-11-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Multiple Electrolytes pH 5.5SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEFresenius Kabi USA, LLCcf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c2022-11-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Adrenal SupportHUMULUS LUPULUS, ADRENALINUM, CORTISONE ACETICUM, SELENIUM METALLICUM, THYROIDINUM (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, FERRUM METALLICUM, NUX VOMICA, PHOSPHORUS, SEPIA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.e7e01040-df38-4628-96d0-4df3420546a42022-11-09WarningsExact identifier
unii: 27YLU75U4W
Unda 24CRATAEGUS FRUIT, PASSIFLORA INCARNATA, BOLDO LEAF, VALERIANA OFFICINALIS ROOT, CHAMOMILLA, ALUMINIUM METALLICUMSeroyal USA0fd99c06-1ea8-7171-e054-00144ff8d46c2022-11-09WarningsExact identifier
unii: G0R4UBI2ZZ
UNDA 28LACTUCA VIROSA, TARAXACUM OFFICINALE, SARSAPARILLA, SPIRAEA ULMARIA, CONDURANGO, ALUMINIUM METALLICUM, CUPRUM METALLICUM, STANNUM METALLICUMSeroyal USA182f4ad8-edf9-468c-e054-00144ff8d46c2022-11-09WarningsExact identifier
unii: ZW3Z11D0JV
UNDA 29ABSINTHIUM, ALLIUM CEPA, ARGENTUM METALLICUM, BETULA PENDULA SAP, LAMIUM ALBUM, SALVIA OFFICINALISSeroyal USA20484d33-4389-1a85-e054-00144ff88e882022-11-09WarningsExact identifier
unii: 492225Q21H
Unda 33ALLIUM CEPA, TILIA EUROPAEA, JATEORHIZA PALMATA, VIOLA TRICOLOR, BOLDO LEAF, ANACARDIUM ORIENTALE FRUI, ALUMINIUM METALLICUMSeroyal USA0e728819-0a1f-26e6-e054-00144ff88e882022-11-09WarningsExact identifier
unii: 492225Q21H
Unda 36ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, ALUMINIUM METALLICUM, CHELIDONIUM MAJUS, HAMAMELIS VIRGINIANA, HYDRASTIS CANADENSIS, HYPERICUM PERFORATUMSeroyal USA26e7d64b-1a94-6de4-e054-00144ff8d46c2022-11-09WarningsExact identifier
unii: ZW3Z11D0JV
ANTI-WARTBUFO RANA, BUXUS SEMPERVIRENS, JUGLANS REGIA, NITRICUM ACIDUM, OLEANDER, STANNUM METALLICUM, SULPHUR, TAXUS BACCATA, THUJA OCCIDENTALIS, VANADIUM METALLICUMSeroyal USA4c45c2e7-e4b7-0a93-e054-00144ff8d46c2022-11-09WarningsExact identifier
unii: 70FD1KFU70
PYROGENIUM PLEXARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI IODATUM, PYROGENIUMSeroyal USA270f98ff-2f0e-6926-e054-00144ff8d46c2022-11-09WarningsExact identifier
unii: ZW3Z11D0JV
unii: 1MBW07J51Q
Drosera PlexCOUGH SYRUPSeroyal USA588871b1-1dae-3053-e053-2a91aa0a81242022-11-09WarningsExact identifier
unii: 70FD1KFU70
Unda 245RHEUM, VIBURNUM PRUNIFOLIUM, THUJA OCCIDENTALIS, PULSATILLA, FAGOPYRUM ESCULENTUMSeroyal USA0d0301ed-2221-7379-e054-00144ff88e882022-11-09WarningsExact identifier
unii: I76KB35JEV
Natrum MuriaticumNATRUM MURIATICUMHahnemann Laboratories, INC.ecf06f13-012c-212d-e053-2995a90a71982022-11-08Exact identifier
unii: 451W47IQ8X
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Unda 39ASAFOETIDA GUM RESIN,ABSINTHIUM, ALLIUM CEPA, TANACETUM VULGARE AERIAL PARTS, CINA FLOWER-HEADS, DRYOPTERIS FILIX-MAS RHIZOME, ARGENTUM METALLICUMSeroyal USA0cc8aa90-b341-1f90-e054-00144ff88e882022-10-25WarningsExact identifier
unii: 492225Q21H
UNDA 2PETROSELINUM SATIVUM, RHAMNUS FRANGULA, THLASPI BURSA-PASTORIS, JUNIPERUS COMMUNIS, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, GENISTA TINCTORIA, ARGENTUM METALLICUMSeroyal USA079c945e-7853-3410-e054-00144ff88e882022-10-25WarningsExact identifier
unii: I76KB35JEV

Reported adverse events (FAERS/openFDA)#

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