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 109 of 163 · 3,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neurotransmitter ProAETHUSA CYNAPIUM, GINKGO BILOBA, KALI PHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALUMINA, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CORTISONE ACETICUM, LEVOTHYROXINUM, LYCOPODIUM CLAVATUM, NADIDUM, PHOSPHORUS, UBIDECARENONUM, ZINCUM METALLICUM, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, GABA (GAMMA-AMINOBUTYRIC ACID), HISTAMINUM HYDROCHLORICUM, MELATONIN, NOREPINEPHRINE (BITARTRATE), OXYTOCIN, SEROTONIN (HYDROCHLORIDE)Energique, Inc.a80e5e2d-4c53-4b18-b89b-a7790073b7ed2024-05-06WarningsExact identifier
unii: 27YLU75U4W
Neurotransmitter ProAETHUSA CYNAPIUM, GINKGO BILOBA, KALI PHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALUMINA, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CORTISONE ACETICUM, LEVOTHYROXINUM, LYCOPODIUM CLAVATUM, NADIDUM, PHOSPHORUS, UBIDECARENONUM, ZINCUM METALLICUM, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, GABA (GAMMA-AMINOBUTYRIC ACID), HISTAMINUM HYDROCHLORICUM, MELATONIN, NOREPINEPHRINE (BITARTRATE), SEROTONIN (HYDROCHLORIDE), OXYTOCINEnergique, Inc.b433c635-e38b-4b3a-89cb-4a72a386ad842024-05-06WarningsExact identifier
unii: 27YLU75U4W
FleetGLYCERINC.B. Fleet Company, Inc.381f4179-0c3b-41f8-927c-c88534ebe06d2024-05-06WarningsExact identifier
unii: PDC6A3C0OX
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.f2475fa3-ab1d-4b81-8127-b58cd0790a542024-05-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 2788Z9758H
AI MiasmASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, SCROPHULARIA NODOSA, THYROIDINUM (SUIS), FORMICUM ACIDUM, PHOSPHORUS, SILICEA, SULPHUR, THUJA OCCIDENTALIS, AURUM METALLICUMEnergique, Inc.df829e4a-c982-4d02-b318-38b1fbc5072d2024-05-02WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
Detox IISOLIDAGO VIRGAUREA, BAPTISIA TINCTORIA, BERBERIS VULGARIS, EQUISETUM HYEMALE, ARGENTUM NITRICUM, CANTHARIS, CAPSICUM ANNUUM, CUPRUM SULPHURICUM, ORTHOSIPHON STAMINEUS, SARSAPARILLA (SMILAX REGELII), BAROSMA (BETULINA), MERCURIUS CORROSIVUS, PAREIRA BRAVA, PYELON (SUIS), TEREBINTHINA, URETER (SUIS), URETHRA (SUIS), URINARY BLADDER (SUIS), ACETALDEHYDE, HEPAR SULPHURIS CALCAREUM, NATRUM PYRUVICUM, QUERCETIN, COLIBACILLINUM CUM NATRUM MURIATICUM, APIS VENENUM PURUM, DYSENTERY BACILLUSDeseret Biologicals, Inc.25718c6d-6b52-42f5-8668-0db6785bbb6f2024-05-02WarningsExact identifier
unii: 1MBW07J51Q
Weed Grass AntigensALLIUM CEPA, ARSENICUM ALBUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS), ABROTANUM (ARTEMISIA ABROTANUM), ABSINTHIUM, AGRIMONIA EUPATORIA, FLOS, ALFALFA, AMBROSIA ARTEMISIAEFOLIA, ARUNDO MAURITANICA, BAMBUSA ARUNDINACEA, CICHORIUM INTYBUS, FLOS, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, RUMEX CRISPUS, SABADILLA, SINAPIS ARVENSIS, FLOS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, TRIFOLIUM REPENS,Energique, Inc.8a28f56a-6010-42e3-b360-e6e22b86222a2024-05-02WarningsExact identifier
unii: 451W47IQ8X
unii: 492225Q21H
Occuloplex GEUPHRASIA OFFICINALIS, GINKGO BILOBA, PETROSELINUM SATIVUM, VACCINIUM MYRTILLUS, ASCORBICUM ACIDUM, SPIGELIA ANTHELMIA, EYE (SUIS), GERMANIUM SESQUIOXIDE, UBIDECARENONUM, AURUM METALLICUM, BRYONIA (ALBA), HEPAR SULPHURIS CALCAREUM, PHOSPHORUS, RUTA GRAVEOLENS, SULPHUR, LITHIUM METALLICUMBioActive Nutritional, Inc.c982e701-129c-4b55-b8e6-ff05178384922024-05-02WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
unii: 1MBW07J51Q
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEFresenius Kabi USA, LLCc2467d57-cd2d-4409-bcc0-50128bd01bba2024-04-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Gallbladder Liver Meridian OpenerARSENICUM ALBUM, BERBERIS VULGARIS, BRYONIA (ALBA), CALCAREA CARBONICA, CARDUUS MARIANUS, CINCHONA OFFICINALIS, KALI CARBONICUM, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUSDeseret Biologicals, Inc.5dbbcf9d-df8c-48f4-91c2-42949ef192392024-04-30WarningsExact identifier
unii: 27YLU75U4W
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREAS SUIS, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.83249aee-f58b-442d-9187-6de0cf070e4d2024-04-29WarningsExact identifier
unii: 70FD1KFU70
GlucoregASCORBICUM ACIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SARCOLACTICUM ACIDUM, THIAMINUM HYDROCHLORICUM, DHEA (DEHYDROEPIANDROSTERONE), ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, ACETALDEHYDE, INSULINUM (SUIS), INSULINUM (HUMAN), HEPAR SUIS, PANCREAS SUIS, PHLORIDZINUM, ALLOXANUM, BERBERIS VULGARIS, CARCINOSIN, LYCOPODIUM CLAVATUM, MOMORDICA BALSAMINA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM,Deseret Biologicals, Inc.c77d0682-a000-4783-a91c-d4e205c347742024-04-29WarningsExact identifier
unii: 27YLU75U4W
Mineffect eye dropsALUMINA SILICATA, CALCAREA FLUORICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, NATRUM MURIATICUM, PHOSPHORUS, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUMKadesh Incoporation Co,Ltde2259f58-3043-4af3-918d-d4403757aa1f2024-04-26WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: 70FD1KFU70
HPYL PLUSANGELICA ARCHANGELICA, GERANIUM MACULATUM, HYDRASTIS CANADENSIS, SINAPIS NIGRA, SYMPHYTUM OFFICINALE, RATANHIA, ACETICUM ACIDUM, CARBOLICUM ACIDUM, ORNITHOGALUM UMBELLATUM, ABIES CANADENSIS, ANACARDIUM ORIENTALE, BISMUTHUM SUBNITRICUM, CONDURANGO, GRAPHITES, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, MEZEREUM, EUPHORBIUM OFFICINARUM, NUX VOMICA, URANIUM NITRICUMDeseret Biologicals, Inc.39445c53-e661-4203-a4fb-a071075ac0e22024-04-26WarningsExact identifier
unii: ZW3Z11D0JV
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEFresenius Kabi USA, LLC7a723a23-3bc1-4f69-b82f-d06a35dc68d62024-04-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Kids Cough and Mucus Daytime Grape FlavorBRYONIA ALBA ROOT,CALCIUM SULFIDE,PULSATILLA VULGARIS WHOLE,FERROSOFERRIC PHOSPHATE,PHOSPHORUS,ANTIMONY POTASSIUM TARTRATE,IPECAC,RUMEX CRISPUS ROOTHyland's Consumer Health Inc.e72c8fdb-2679-86b3-e053-2a95a90a6cdf2024-04-23WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
unii: 1MBW07J51Q
Kids Cough and Mucus Nighttime GrapeANTIMONY POTASSIUM TARTRATE,BRYONIA ALBA ROOT,CALCIUM SULFIDE,CHAMOMILE,FERROSOFERRIC PHOSPHATE,GOLDENSEAL,IPECAC,PHOSPHORUS,PULSATILLA VULGARIS,RUMEX CRISPUS ROOTHyland's Consumer Health Inc.e76509f9-6219-908e-e053-2a95a90a21b32024-04-23WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: I76KB35JEV
unii: 1MBW07J51Q
VACC HCHEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, LAC FELINUM, MERCURIUS SOLUBILIS, NICOTINAMIDUM, SENEGA OFFICINALIS, SPIGELIA ANTHELMIA, SULPHUR, ZINCUM METALLICUMDeseret Biologicals, Inc.a98082ba-21ec-4cf8-b81c-bcb41eb9fd122024-04-23WarningsExact identifier
unii: 70FD1KFU70
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCc1e52670-c85e-4f19-a2e9-bf9abd7c37272024-04-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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