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 96 of 163 · 3,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Emvita 7ANACARD OCC, GLANDULA SUP, LACHESIS MUTUS, LYCOPODIUM, PHOSPHORUSRUBIMED AG45aa87c9-b12d-4eb9-aa2d-1bd800a4ee6c2024-10-29WarningsExact identifier
unii: 27YLU75U4W
Emvita 6ARSENICUM ALBUM, GLANDULA SUP, LACHESIS MUTUS, PHOSPHORUS, SECALE CORNUTUMRUBIMED AGb7e34079-56ee-4278-ae13-09df58b371542024-10-29WarningsExact identifier
unii: 27YLU75U4W
Emvita 10AGNUS CASTUS, ARUM TRIPH, HEPAR SULPH CALC, LACHESIS, PANCREAS, PETROLEUMRUBIMED AG8f1c0785-48bc-4ffc-98bc-c71614a67bee2024-10-29WarningsExact identifier
unii: 1MBW07J51Q
Emvita 15APIS MELLIFICA, LACHESIS MUTUS, PHOSPHORUS, THYMUS GLAND, ZINC METRUBIMED AG5467725e-814a-4b44-84c9-b89f70f017af2024-10-29WarningsExact identifier
unii: 27YLU75U4W
Emvita 17BARYTA CARB, CHININUM ARS, GRAPHITES, PULSATILLA, THYROIDINUMRUBIMED AGae66ac27-182f-4ff9-a656-1d547955c54a2024-10-29WarningsExact identifier
unii: I76KB35JEV
Emvita 20APIS MELLIFICA, BELLADONNA, CANTHARIS, HYPOPHYSIS, IGNATIA AMARA, MAG CARB, PHOSPHORUS, PULSATILLARUBIMED AG79aa12bc-4279-485f-9253-faacc4d2199c2024-10-29WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
Emvita 21ARSENICUM ALB, CHAMOMILLA, HYPOPHYSIS, LACHESIS MUTUS, MAG CARBRUBIMED AG46ddfe55-5189-4e43-9e30-44a33bb4a7a72024-10-29WarningsExact identifier
unii: G0R4UBI2ZZ
Emvita 24CHAMOMILLA, CROTALUS HORRIDUS, HYPOPHYSIS, IGNATIA AMARA, PHOSPHORUSRUBIMED AGbea3529e-4757-433c-b005-999f2ed5ab322024-10-29WarningsExact identifier
unii: 27YLU75U4W
unii: G0R4UBI2ZZ
Chavita 3ARGENTUM MET, CHAMOMILLA, CHELIDONIUM MAJUS, NUX VOMICA, PANCREAS SUIS, LYCOPODIUM, ZINGIBERRUBIMED AG4895e274-7fa7-4f2f-a536-fa883505ead42024-10-29WarningsExact identifier
unii: G0R4UBI2ZZ
Emvita 3APIS MELLIFICA, BOVISTA, CONIUM, HEPAR SULPH CALC, OOPHORINUM, ORCHITINUMRUBIMED AG4a948c18-2675-40a3-9c3e-327b05396ce92024-10-29WarningsExact identifier
unii: 1MBW07J51Q
SimvitaCEREBRUM, CHAMOMILLA, EPHEDRA VULGARIS, SECALERUBIMED AG82331ea9-bd10-4f06-8c7c-d4ef47d585d62024-10-29WarningsExact identifier
unii: G0R4UBI2ZZ
Emvita 14CALC CARB, HYOSCYAMUS NIGER, MOSCHUS, PLUMB MET, STRAMONIUM, SULPHUR, THYMUS GLANDRUBIMED AG70938f35-64e2-4609-a12a-02f1cbc358282024-10-29WarningsExact identifier
unii: 70FD1KFU70
Emvita 9HEPAR SULPH CALC, LYCOPODIUM, PANCREAS, SULPHUR, TARENTULA HISPANARUBIMED AGa430dd38-c07b-47c9-bfa4-af33fab9f0f62024-10-29WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
Emvita 5BUFO RANA, CUPRUM METALLICUM, GLANDULA SUPRARENALIS, PHOSPHORUS, PULSATILLA, ZINCUM METALLICUMRUBIMED AG2a141ded-a864-422f-8eb4-69d65fb59c152024-10-29WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
Chavita 5PHOSPHORUS, THUJA OCCIDENTALIS, THYROIDINUM, VIOLA TRICRUBIMED AG583f0e23-e2ab-4756-9d86-33421086e3c82024-10-29WarningsExact identifier
unii: 27YLU75U4W
Nat MurNATRUM MURIATICUMEnergique, Inc.39c4cb25-e70f-4d5a-b7b6-1b62527aa4f32024-10-29WarningsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC68cc9c41-ed24-4f76-8efb-2936ae3ddd8d2024-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Psora MiasmEGGSHELL MEMBRANE, WHEY PROTEIN, CALCAREA CARBONICA, LYCOPODIUM CLAVATUM, SULPHUR, ARSENICUM ALBUM, FAGOPYRUM ESCULENTUM, GRAPHITES, HYDROCOTYLE ASIATICA, NATRUM MURIATICUMEnergique, Inc.d008a091-b7c6-41f1-a1cf-f8224ebe55e52024-10-29WarningsExact identifier
unii: 451W47IQ8X
unii: 70FD1KFU70
PulmoparLOBELIA INFLATA, LUNG (SUIS), SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, BLATTA ORIENTALIS, BRYONIA (ALBA), PHOSPHORUS, SILICEA, SULPHUREnergique, Inc.1cfb69c5-dc01-4acc-8053-5ca4e64165dc2024-10-29WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
Multi-Cell SaltKALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CALCAREA SULPHURICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, MAGNESIA PHOSPHORICA, SILICEAEnergique, Inc.dad00225-b3ac-4e36-a856-19b0faf42c422024-10-29WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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