FDA.reportPublic FDA data

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 5 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thyro-ChordHOMEOPATHIC LIQUIDEnergetix Corporation6655b504-dfa8-46df-9d3a-b7fa4078207e2026-08-11WarningsExact identifier
unii: 2788Z9758H
unii: I76KB35JEV
Sinus-ToneALLIUM CEPA, ECHINACEA, HYDRASTIS CANADENSIS, KALI BICHROMICUM, MERCURIUS SOLUBILIS, MERCURIUS SULPHURATUS RUBER, MUCOSA NASALIS SUIS, NATRUM SULPHURICUM, NUX MOSCHATA, PULSATILLA.Energetix Corporatione4dc6772-40c7-42af-8531-20b8d1883fb42026-08-11WarningsExact identifier
unii: 492225Q21H
unii: ZW3Z11D0JV
unii: I76KB35JEV
Relax-ToneCALCAREA CARBONICA, COFFEA CRUDA, HUMULUS LUPULUS, IGNATIA AMARA, KALI PHOSPHORICUM, MOSCHUS, NUX VOMICA, PASSIFLORA INCARNATE, PHOSPHORUS, PULSATILLA VULGARIS, STAPHYSAGRIA, VALERIANA OFFICINALISEnergetix Corporation85563888-8097-4af4-8ab1-b6d6e545b4992026-08-11WarningsExact identifier
unii: 27YLU75U4W
unii: 3SW678MX72
unii: I76KB35JEV
Neuro-ChordHOMEOPATHIC LIQUIDEnergetix Corporation462c21ba-7304-3606-e063-6294a90aab212026-08-11WarningsExact identifier
unii: 27YLU75U4W
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: 451W47IQ8X
unii: ZW3Z11D0JV
Metal-ChordALLIUM CEPA, ALLIUM SATIVUM, ALPHA-LIPOICUM ACIDUM, ALUMINA, ARSENICUM METALLICUM, BERBERIS VULGARIS, CADMIUM METALLICUM, CARDUUS MARIANUS, CETRARIA ISLANDICA, CUPRUM METALLICUM, CYSTEINUM, GLYCYRRHIZA GLABRA, HEPAR SUIS, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NUX VOMICA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PYRIDOXINUM HYDROCHLORICUM, SELENIUM METALLICUM, STILLINGIA SYLVATICA, THYROIDINUM, TRIFOLIUM PRATENSE, ZINGIBER OFFICINALEEnergetix Corporationea4d26a8-acf2-46ed-9a69-df7764cc4cfd2026-08-11WarningsExact identifier
unii: 2788Z9758H
unii: 492225Q21H
Restful Legs PMANEMONE PATENS,MATRICARIA CHAMOMILLA,SULFUR,ZINC,TOXICODENDRON PUBESCENS LEAF,ARSENIC TRIOXIDE,ARABICA COFFEE BEAN,LYCOPODIUM CLAVATUM SPOREHyland's Inc.67667af8-b27b-1511-e053-2991aa0a39882026-08-11WarningsExact identifier
unii: 3SW678MX72
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
Restful LegsARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINCHyland's Inc.36e5843c-916a-425c-becc-15674cda7a652026-08-11WarningsExact identifier
unii: 70FD1KFU70
unii: I76KB35JEV
dermveda ULTRA HEMORRHOID AND FISSURESULFUR, CURCUMA LONGACelcius Corp.044e0503-215b-4d57-96d9-62a54a8de4d12026-08-10WarningsExact identifier
unii: 70FD1KFU70
dermveda ATHLETES FOOTSULPHUR, CURCUMA LONGACelcius Corp.1741c97e-b178-4a37-a201-7b9610e06c8a2026-08-10WarningsExact identifier
unii: 70FD1KFU70
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Similasan Earache ReliefCHAMOMILE, MERCURIUS SOLUBILIS, SULFURSimilasan Corporation3b48e1d5-5e74-415b-a460-e4d96899dbb62026-08-05WarningsExact identifier
unii: 70FD1KFU70
Gluten Sensitivity FormulaLYCOPODIUM CLAVATUM, PULSATILLAThe Wise Alternative42b2d54a-5e02-44ed-8172-a45c5addf7c22026-08-04WarningsExact identifier
unii: I76KB35JEV
Easment Itch Defense Sulfur CreamSULFUR 1X HPUSEasment LLC5835f842-6428-0782-e063-6294a90ad1822026-08-04WarningsExact identifier
unii: 70FD1KFU70
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
Jointox BBBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, BORRELIA BURGDORFERI NOSODE, BABESIA MICROTI, EHRLICHIA NOSODE (CANINE), HEPATITIS B NOSODE, MENINGOCOCCUS NOSODE, ARSENICUM ALBUM, BRYONIA (ALBA), CHELIDONIUM MAJUS, COLCHICUM AUTUMNALE, KALMIA LATIFOLIA, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, PHOSPHORUS, RHUS TOXEnergique, Inc.acb949d3-1def-4a17-a159-a79614b8f77d2026-07-31WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
NeurostatCIMICIFUGA RACEMOSA, AGARICUS MUSCARIUS, COCCUS CACTI, CONIUM MACULATUM, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, PHOSPHORUS, RHUS TOX, TARENTULA CUBENSIS, LATRODECTUS MACTANS, PYROGENIUMEnergique, Inc.028d842f-3abd-421e-b6b8-07313ef690b82026-07-31WarningsExact identifier
unii: 27YLU75U4W
Acne Clearing Sulfur MaskSULFURAcneFree, LLCc0675282-ff00-edba-e053-2995a90ace682026-07-31WarningsExact identifier
unii: 70FD1KFU70
Sulfur Acne Foaming CleanserSULFURAcne Free, LLCfeb82a3d-cda3-c62a-e053-6394a90ad9bb2026-07-31WarningsExact identifier
unii: 70FD1KFU70
sulfur acne treatmentSULFURAcne Free105545d8-974c-5a9a-e063-6294a90aecc42026-07-31WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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