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 131 of 160 · 3,195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SystemistatBERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, HYDRASTIS CANADENSIS, HEPAR SULPHURIS CALCAREUM, LYCOPODIUM CLAVATUM, SULPHUR, CALCAREA CARBONICA, MERCURIUS SOLUBILIS, THUJA OCCIDENTALISEnergique, Inc.0d8aa575-3fae-4828-8827-d2561672a91e2023-04-21WarningsExact identifier
unii: ZW3Z11D0JV
unii: 70FD1KFU70
unii: 1MBW07J51Q
Boost LiquescenceECHINACEA ANGUSTIFOLIA, POPULUS CANDICANS, HYDRASTIS CANADENSIS, KALI BICHROMICUM, HEPAR SULPHURIS CALCAREUM, MERCURIUS SOLUBILIS.Nutritional Specialties, Inc.206b37a6-0799-4c89-8079-bec570e451432023-04-17WarningsExact identifier
unii: ZW3Z11D0JV
unii: 1MBW07J51Q
CosmestatALFALFA, AVENA SATIVA, IODIUM, BOVISTA, FORMALINUM, HYPOPHYSIS SUIS, MANGANUM ACETICUM, NATRUM MURIATICUM, PETROLEUM, PULSATILLA (PRATENSIS), RHUS TOX, TEREBINTHINA, THYROIDINUM (BOVINE), CORTISONE ACETICUMEnergique, Inc.edc8eb65-84b3-433f-8aad-7a741f5637182023-04-17WarningsExact identifier
unii: 451W47IQ8X
Baby Nighttime Mucus Plus Cold ReliefCALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.736b2487-e81d-d172-e053-2a91aa0ab0cf2023-04-17WarningsExact identifier
unii: 27YLU75U4W
unii: 3SW678MX72
unii: 451W47IQ8X
unii: 492225Q21H
unii: ZW3Z11D0JV
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
unii: I76KB35JEV
unii: 1MBW07J51Q
BHI Flu PlusACONITUM NAPELLUS, CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE, BRYONIA ALBA WHOLE, EUPATORIUM PERFOLIATUM FLOWERING TOP, IPECAC, LACHESIS MUTA VENOM,PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, ZINC GLUCONATE, AND ZINCMediNatura Inc8d73082d-a1bc-4e76-9714-49f718b5850b2023-04-13WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
unii: I76KB35JEV
RadialginCITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAYNutritional Specialties, Inc.f1414ae2-4068-4076-bf11-b57a34ba5df22023-04-12WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
ChamomillaCHAMOMILLANewton Laboratories, Inc.f912a32e-9bc9-c195-e053-6294a90a3e202023-04-11WarningsExact identifier
unii: G0R4UBI2ZZ
Hydrastis canadensisGOLDENSEALBoiron85b9d833-1f50-32a9-e053-2991aa0a4a9c2023-04-11Exact identifier
unii: ZW3Z11D0JV
SulphurSULPHURNewton Laboratories, Inc.f9142532-84eb-1e4f-e053-6394a90afc152023-04-11WarningsExact identifier
unii: 70FD1KFU70
SulphurSULFURBoiron8697e70b-a99c-8c9a-e053-2991aa0a9b8e2023-04-11Exact identifier
unii: 70FD1KFU70
EnviroforceSARSAPARILLA (SMILAX REGELII), XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, AURUM METALLICUM, CARBO ANIMALIS, CAUSTICUM, IODIUM, SULPHUR, THUJA OCCIDENTALISBioActive Nutritional, Inc.9f364896-8626-49db-aef9-6fbf15e46d8f2023-04-10WarningsExact identifier
unii: ZW3Z11D0JV
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, URANIUM NITRICUM, EUPHORBIUM OFFICINARUM, NUX VOMICADeseret Biologicals, Inc.a13a91e0-572a-4f9c-b80e-f161f055e6fd2023-04-10WarningsExact identifier
unii: ZW3Z11D0JV
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
VitalizerECHINACEA (ANGUSTIFOLIA), IODIUM, ARSENICUM ALBUM, AURUM METALLICUM, CALCAREA FLUORICA, GALLICUM ACIDUM, HEKLA LAVA, NICCOLUM SULPHURICUM, PHOSPHORUS, SEDUM ACRE, SEMPERVIVUM TECTORUM, SENECIO AUREUS, BLATTA AMERICANA, ONOSMODIUM VIRGINIANUMBioActive Nutritional, Inc.a643abc6-5367-4b34-848a-83bdb6ddd87d2023-04-06WarningsExact identifier
unii: 27YLU75U4W
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlutenstatALFALFA, ZINGIBER OFFICINALE, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, BARLEY (GRAIN), CARBO VEGETABILIS, GLYPHOSATE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN), GLUTENEnergique, Inc.c6b867b6-74d9-4725-90d7-7d5d1fe611212023-04-05WarningsExact identifier
unii: 451W47IQ8X
unii: ZW3Z11D0JV
unii: I76KB35JEV
AnxietyBORAX, NATRUM MURIATICUM, CAUSTICUM, ELETTARIA CARDAMOMUM, PLUMBUM METALLICUM, SEPIA, LILIUM TIGRINUM, OXYTROPIS LAMBERTIINutritional Specialties, Inc.657ed32f-3ac7-4806-96b4-4c7aa0f65e7f2023-04-03WarningsExact identifier
unii: 451W47IQ8X
Virility LiquescenceAVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIANutritional Specialties, Inc.81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f2023-03-29WarningsExact identifier
unii: 27YLU75U4W
unii: PDC6A3C0OX
unii: 451W47IQ8X
Pancreas LiquescenceCINNAMOMUM, GYMNEMA SYLVESTRE, PHOSPHORICUM ACIDUM, SYZYGIUM JAMBOLANUM, TRIGONELLA FOENUM-GRACEUM, ARGENTUM NITRICUM, CHIONANTHUS VIRGINICA, HEPAR SUIS, PANCREAS SUIS, RHUS AROMATICA, SULPHUR, LYCOPODIUM CLAVATUM, CHROMIUM PICOLINATE, CHROMIUM METALLICUM, PHOSPHORUS, VANADIUM METALLICUM, ZINCUM METALLICUM, MUREX PURPUREA, DNA, INSULINUM (HUMAN), URANIUM NITRICUMNutritional Specialties, Inc.06300339-b068-4685-8475-3765f68288512023-03-27WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
Hepar sulphuris calcareumCALCIUM SULFIDEBoiron85b66774-93c2-d76c-e053-2a91aa0a99d32023-03-27Exact identifier
unii: 1MBW07J51Q

Reported adverse events (FAERS/openFDA)#

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