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 157 of 160 · 3,181 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dust Mix AntigenANTIMON TART, ARSENICUM ALB, BLATTA OR, BROMIUM, CALC CARB, CIMEX, DROSERA, HEPAR SULPH CALC, ICTODES FOETIDA, LYCOPODIUM, PHOS, PULSATILLA, SILICEA TERRA, TABACUM FUMUSNatural Creations, Inc8dab4b4a-6fa8-4258-adc1-f8c634e2030b2018-12-21WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
unii: 1MBW07J51Q
Nasal DecongestantCAMELLIA SINENSIS, EPHEDRA VULGARIS, BELLADONNA, ARSENICUM ALBUM, CINNABARIS, KALI BICHROMICUM, PULSATILLA, SEPIA, CALCAREA CARBONICA, MERCURIUS SOLUBILIS, SULPHURNatural Creations, Inc938a25f8-e854-4537-a04d-5e2276199f5c2018-12-21WarningsExact identifier
unii: 70FD1KFU70
unii: I76KB35JEV
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Acne LotionSulfur SulfurSULFURAllure Labs Inc487d2e65-7fb0-4eee-a082-6b2c192eaf272018-11-09WarningsExact identifier
unii: 70FD1KFU70
Metabolic DetoxBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, SARSAPARILLA (SMILAX REGELII), GELSEMIUM SEMPERVIRENS, VERATRUM ALBUM, FERRUM METALLICUM, IODIUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PULSATILLA (VULGARIS), SELENIUM METALLICUM, THUJA OCCIDENTALIS, ZINCUM METALLICUMHealthsource of New England LLCa4d0cb2d-a8c0-422a-a8fd-c8f92edcef442018-10-18WarningsExact identifier
unii: I76KB35JEV
Nightshade AntigenCAPSICUM ANNUUM, SOLANUM TUBEROSUM, TABACUM, LYCOPERSICUM ESCULENTUM, SOLANUM MELONGENA, ALUMINUM METALLICUM, ARSENICUM ALBUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS)BioActive Nutritional, Inc.47571afb-fa53-4c5b-ba35-8f0609a2bd752018-09-25WarningsExact identifier
unii: 27YLU75U4W
WinCo Foods Saline Nasal ReliefSODIUM CHLORIDEWinCo Foods, LLC1280fee4-e763-49ba-8722-8cdb8157f1a42018-08-02WarningsExact identifier
unii: 451W47IQ8X
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: OJ245FE5EU
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation05dee566-7b82-4216-8a6b-765d2b4d9dc72018-07-17Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Diathesis IMANGANUM METALLICUM, GERMANIUM SESQUIOXIDE, FEL TAURI, HEPAR SUIS, GINKGO BILOBA, CYSTEINUM, MANGANESE GLUCONATE, ALPHA-KETOGLUTARICUM ACIDUM, ARSENICUM ALBUM, FUMARICUM ACIDUM, PHOSPHORUS, SODIUM OXALATE, SULPHURBioActive Nutritionals, Inc.e8c3b763-7d54-48b1-8db8-a5b47ce7aeeb2018-07-13WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
GB-ToneAMMI VISNAGA, ATROPINUM SULPHURICUM, BOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, ECHINACEA, FEL TAURI, HEPAR SUIS, HYDRASTIS CANADENSIS, LEPTANDRA VIRGINICA, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, PODOPHYLLUM PELTATUM, TARAXACUM OFFICINALEEnergetix Corp5620a1dc-b59c-4489-a548-20f3e488287f2018-07-11WarningsExact identifier
unii: ZW3Z11D0JV
Bacteria ChordAZADIRACHTA INDICA, BELLADONNA, BERBERIS VULGARIS, BOLDO, CANDIDA ALBICANS, CEANOTHUS AMERICANUS, CETRARIA ISLANDICA, CROTALUS HORRIDUS, ECHINACEA (ANGUSTIFOLIA), GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HAMAMELIS VIRGINIANA, HEPAR SUIS, HYDRASTIS CANADENSIS, HYDROCOTYLE ASIATICA, HYPERICUM PERFORATUM, LAPPA MAJOR, LEDUM PALUSTRE, MILLEFOLIUM, MORBILLINUM, MYRRHA, PANCREAS SUIS, PERTUSSINUM, PHOSPHORUS, PLANTAGO MAJOR, PYROGENIUM, SOLIDAGO VIRGAUREA, ZINGIBER OFFICINALEEnergetix Corpf12539de-a737-437e-9392-727208275ba12018-07-11WarningsExact identifier
unii: 27YLU75U4W
unii: 2788Z9758H
unii: ZW3Z11D0JV
HA HPBELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIABioActive Nutritional, Inc.30f6c191-ce6e-438c-9601-74f5e8b61f962018-07-06WarningsExact identifier
unii: 451W47IQ8X
Metabolic SupportFUCUS VESICULOSUS, AGNUS CASTUS, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHYTOLACCA DECANDRA, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, CARBO VEGETABILIS, GRAPHITES, CALCAREA CARBONICA, NATRUM PHOSPHORICUM, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, THYROIDINUM (SUIS)BodyLogicMD of Fort Lauderdalec2a1bd6d-c595-402f-a3bc-23f64c949d782018-06-08WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation181705c7-40e4-4d7d-b9ea-ada99380e7a92018-05-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation7c72520e-de3c-493d-8aea-11933376d9682018-04-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
EAR CARE EARACHE DROPSATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, AND SULFURRite Aid Corporation58f1f79f-f1dd-3094-e053-2991aa0ac5912018-03-16WarningsExact identifier
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
unii: I76KB35JEV
Immuno FortifierECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LIGUSTICUM PORTERI, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, TRIGONELLA FOENUM-GRAECUM, ASCORBIC ACID, PINUS SYLVESTRIS, LYMPH (SUIS), MEDULLA OSSIS SUIS, SPLEEN (SUIS), THYMUS (SUIS), HEPAR SULPHURIS CALCAREUM, PHOSPHORICUM ACIDUM, SILICEABioActive Nutritional, Inc.04024663-0b11-438a-a21a-8e86edd8052a2018-01-15WarningsExact identifier
unii: ZW3Z11D0JV
unii: 1MBW07J51Q
Lactated RingersSODIUM CHLORIDE, SOLDIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDEBaxter Healthcare Company5215ec33-8cfe-4885-ae92-e6a12100bd272018-01-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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