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 146 of 160 · 3,181 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SULPHURSULPHURRxhomeo Private Limited d.b.a. Rxhomeo, Inc61a36a56-4e62-4721-81fb-ee8dcd08b4d82021-09-02WarningsExact identifier
unii: 70FD1KFU70
PULSATILLAPULSATILLARxhomeo Private Limited d.b.a. Rxhomeo, Incd8607ae4-3fbb-4c0a-9b3b-d9b6ad671c732021-09-02WarningsExact identifier
unii: I76KB35JEV
HEPAR SULPHURIS CALCAREUMHEPAR SULPHURIS CALCAREUMRxhomeo Private Limited d.b.a. Rxhomeo, Ince35ab095-c0c3-423a-9ba3-3d26b74bf3222021-09-02WarningsExact identifier
unii: 1MBW07J51Q
NATRUM MURIATICUMNATRUM MURIATICUMRxhomeo Private Limited d.b.a. Rxhomeo, Inc520edb18-5f2a-4448-ba53-83408a839e1f2021-09-02WarningsExact identifier
unii: 451W47IQ8X
PHOSPHORUSPHOSPHORUSRxhomeo Private Limited d.b.a. Rxhomeo, Inc21fa8f76-af69-4812-b291-a6bdeffbfd002021-09-02WarningsExact identifier
unii: 27YLU75U4W
CHAMOMILLACHAMOMILLARxhomeo Private Limited d.b.a. Rxhomeo, Inc7e21364d-0617-46a7-a03c-33c4273ecc072021-09-02WarningsExact identifier
unii: G0R4UBI2ZZ
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Lactated Ringers IrrigationSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDEB. Braun Medical Inc.0db56c7a-2b8f-4593-8591-2c481c92b2cf2021-08-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium Chloride for IrrigationSODIUM CHLORIDE FOR IRRIGATIONB. Braun Medical Inc.5bd9b176-0402-4a3f-a6b4-c3f393fc092a2021-08-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FungisodeARSENICUM ALBUM, BERBERIS VULGARIS, CALCAREA CARBONICA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, ECHINACEA PURPUREA, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NITRICUM ACIDUM, OXALICUM ACIDUM, SEPIA OFFICINALIS, SULPHURSeroyal USA55c5dfc4-3757-6ac2-e054-00144ff88e882021-07-22WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
HLU PNEUMO DROPSARSENICUM IODATUM, CALCAREA PHOSPHORICA, CARBO VEGETABILIS, ORYCTOLAGUS CUNICULUS LUNG, PHELLANDRIUM AQUATICUM, SILICEA, STANNUM METALLICUM, SULPHUR, THYMUS VULGARISSeroyal USA2f0acce5-aad5-1dd3-e054-00144ff88e882021-07-22WarningsExact identifier
unii: 70FD1KFU70
HPTPARNICA MONTANA, ACHILLEA MILLEFOLIUM, ERIGERON CANADENSIS, HYDRASTIS CANADENSIS, ORYCTOLAGUS CUNICULUS, SABINA, SECALE CORNUTUMSeroyal USA23078896-9618-084c-e054-00144ff88e882021-07-22WarningsExact identifier
unii: ZW3Z11D0JV
0.9% SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstc755e41b-acba-7234-e053-2995a90aff0f2021-07-17Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sleep AidADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)Pro Weight Loss Inc.d0af311a-e975-4236-8c0e-0418efa7e45f2021-07-16WarningsExact identifier
unii: 3SW678MX72
unii: G0R4UBI2ZZ
Passiflora PlexPASSIFLORA INCARNATA, IGNATIA AMARA, JALAPA, COFFEA CRUDA, MAGNESIUM METALICUM, PALLADIUM METALLICUM, TELLURIUM METALLICUM, PHOSPHORICUM ACIDUMSeroyal USA0eabdf34-4d4c-3282-e054-00144ff8d46c2021-07-15WarningsExact identifier
unii: 3SW678MX72
UNDA 5TORMENTILLA, TUSSILAGO FARFARA, ADIANTUM CAPILLUS-VENERIS, GLYCYRRHIZA GLABRA, DROSERA, GRINDELIA, INULA HELENIUM, CUPRUM METALLICUM, ARGENTUM METALLICUMSeroyal USA1789ed21-3bc9-3b86-e054-00144ff88e882021-07-15WarningsExact identifier
unii: 2788Z9758H
unii: ZW3Z11D0JV
Unda 3EQUISETUM ARVENSE STEM, CHAMOMILLA, CONDURANGO BARK, VIOLA TRICOLOR, BOLDO LEAF, ALUMINIUM METALLICUM, STANNUM METALLICUMSeroyal USA1583cf73-c22c-0fa8-e054-00144ff8d46c2021-07-15WarningsExact identifier
unii: G0R4UBI2ZZ
UNDA 22ABSINTHIUM, ACONITUM NAPELLUS, ARGENTUM METALLICUM, BOLDO LEAF, CHAMOMILLA, COFFEA TOSTA, JATEORHIZA PALMATA, MANGANUM OXYDATUM NIGRUM, SALVIA OFFICINALISSeroyal USA2044a04e-275f-3f16-e054-00144ff8d46c2021-07-15WarningsExact identifier
unii: G0R4UBI2ZZ
UNDA 210BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALISSeroyal USA205b68ed-ff41-3559-e054-00144ff88e882021-07-15WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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