NDC 54973-3377-01 - 4 Kids Cold and Cough Nighttime Natural Grape Flavor

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
54973-3377
Requested NDC
54973-3377-01
Package NDCs from labels
54973-3377-1, 54973-3377-2, 54973-3377-3, 54973-3377-4, 54973-3377-01
Manufacturer
Hyland's Inc.
Effective date
2025-12-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hyland's Kids Cold & Cough Nighttime Natural Grape FlavorHyland's Inc.2025-12-19HUMAN OTC DRUG LABEL
Hyland's Kids Cold 'n Cough Day & Night Combo Pack Grape FlavorHyland's Inc.2025-12-19HUMAN OTC DRUG LABEL
4 KIDS COLD N COUGH GRAPE FLAVOR - Hyland's Inc. | Applied Laboratories, IncHyland's Inc. | Applied Laboratories, Inc2025-02-20HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3377-14 Kids Cold and Cough Nighttime Natural Grape Flavor1 in 1 CARTONLIQUID113
54973-3377-14 Kids Cold and Cough Nighttime Natural Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID11813
54973-3377-24 Kids Cold and Cough Nighttime Natural Grape Flavor5 mL in 1 PACKETLIQUID513
54973-3377-34 Kids Cold and Cough Nighttime Natural Grape Flavor148 mL in 1 BOTTLE, PLASTICLIQUID14813
54973-3377-34 Kids Cold and Cough Nighttime Natural Grape Flavor1 in 1 CARTONLIQUID113
54973-3377-44 Kids Cold and Cough Nighttime Natural Grape Flavor5 mL in 1 POUCHLIQUID513
54973-3377-14 Kids Cold and Cough Day and Night Grape Flavor1 in 1 CARTONLIQUID6 [hp_X] in 1mL11
54973-3377-14 Kids Cold and Cough Day and Night Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12 [hp_X] in 1mL11
54973-3377-14 Kids Cold and Cough Day and Night Grape Flavor1 in 1 CARTONLIQUID6 [hp_X] in 1mL3
54973-3377-14 Kids Cold and Cough Day and Night Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12 [hp_X] in 1mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-33774 KIDS COLD AND COUGH NIGHTTIME NATURAL GRAPE FLAVOR (ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN) LIQUID [HYLAND'S INC.]10Current NDC, Legacy NDC, 6 package rows20230623_7923e59a-f62c-44df-e053-2991aa0afc1e.zip
54973-33774 KIDS COLD AND COUGH DAY AND NIGHT GRAPE FLAVOR (ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN) KIT [HYLAND'S INC.]7Current NDC, Legacy NDC20250502_79f26bb5-15ad-e40a-e053-2991aa0aaab3.zip
54973-33774 KIDS COLD AND COUGH DAY AND NIGHT GRAPE FLAVOR (ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN) KIT [HYLAND'S INC.]3Current NDC, Legacy NDC20250223_1a297e56-4cb8-75ca-e063-6294a90a592b.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 27 of 160 · 3,196 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
unii: PDC6A3C0OX
CVS ULTRA FINE MOISTURIZING SALINE MISTNASAL MISTCVS44821c47-63f9-5d0a-e063-6394a90a555d2026-01-29WarningsExact identifier
unii: 451W47IQ8X
Varicose VeinsELAPS CORALLINUS, CROTALUS HORRIDUS, BRYONIA, CALC. FLUOR., CARDUUS MAR., CHOLESTERINUM, CINCHONA, DIGITALIS, HAMAMELIS, HYDROFLUORICUM ACIDUM, LACHESIS, LYCOPODIUM, NAJA, PULSATILLA, VIPERA BERUS, ZINC. MET., AESCULUS HIPP., ECHINACEANewton Laboratories, Inc.91e8e37c-c654-6df9-e053-2995a90aafe12026-01-29WarningsExact identifier
unii: I76KB35JEV
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Weight Loss support Plus - GLP 1 BoosterFOENICULUM VULGARE, AMMONIUM BROMATUM, BERBERIS VULGARIS, CINNAMOMUM, FUCUS VESICULOSUS, LECITHIN (DERIVED FROM EGG), TRIGONELLA FOENUM-GRAECUM, PANAX GINSENG, CAPSICUM ANNUUM, CURCUMA LONGA, GALIUM APARINE, HEPAR SUIS, HYPOTHALAMUS SUIS, KALI BICHROMICUM, LAC DEFLORATUM, PANCREAS SUIS, PHYTOLACCA DECANDRA, SMALL INTESTINE (SUIS), PITUITARUM POSTERIUM (BOVINE), THYROIDINUM (BOVINE), ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, CALCAREA CARBONICA, ADRENALINUM, PHOSPHORUSCarolinas Weight Loss Institute999b7ec4-01cc-4d26-9931-48af410ae83f2026-01-29WarningsExact identifier
unii: 27YLU75U4W
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
unii: PDC6A3C0OX
OHM-INSAVENA SATIVA, COFFEA CRUDA, IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALISOHM PHARMA INC.17955ff8-a3ec-4cb6-aa51-fe0665e10f232026-01-28WarningsExact identifier
unii: 3SW678MX72
OHM-RESBACONITUM, ARANEA, BRYONIA, EQUISETUM, EUPATORIUM PERF, HYDRASTIS, JUGLANS REG, KALI BIC, PHOSPHORUS, SARSAPARRILLA, SULPHUROHM PHARMA INC.49e4b472-9ac3-465e-acfa-8879939ce7b42026-01-28WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
OHM-RENAPIS MELLIFICA, ARANEA DIADEMA, BERBERIS VULGARIS, CANTHARIS, EQUISETUM HYEMALE, HYDRASTIS CANADENSIS, JUGLANS REGIA, KALI BICHROMICUM, MERCURIUS SOLUBILIS, SARSAPARILLA, SOLIDAGO VIRGAUREAOHM PHARMA INC.0ed80100-8bce-4d1e-b837-2bbbde8bf9022026-01-28WarningsExact identifier
unii: ZW3Z11D0JV
ContessaALCHEMILLA VULGARIS, ASPERULA ODORATA, CHAMOMILLA, VIOLA ODORATA, CINCHONA OFFICINALIS, MENTHA PIPERITA, ROSMARINUS OFFICINALIS, VALERIANA OFFICINALIS, HELONIA DIOICA, AGNUS CASTUS, AMBRA GRISEA, CIMICIFUGA RACEMOSA, CONVALLARIA MAJALIS, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, DAMIANA, HYDRASTIS CANADENSIS, CAULOPHYLLUM THALICTROIDES, LILIUM TIGRINUM, SENECIO AUREUS, STAPHYSAGRIA, NAJA TRIPUDIANSMarco Pharma International LLC.5a8ae10c-87a4-4751-9885-d84b0cad574a2026-01-26WarningsExact identifier
unii: ZW3Z11D0JV
unii: G0R4UBI2ZZ
Sodium ChlorideSODIUM CHLORIDENephron Pharmaceuticals Corporationa4edf2d5-a9ff-30d4-e053-2995a90a56502026-01-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Pollen DistressALLIUM CEPA, APIS MELLIFICA, ARALIA RACEMOSA, ARUNDO MAURITANICA, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, RHUS TOX, SABADILLA, SANGUINARIA CANADENSIS, URTICA URENSLiddell Laboratories, Inc.034fcd90-81f7-4597-b58b-e2ed7047f6bd2026-01-26WarningsExact identifier
unii: 492225Q21H
DHC Acne Spot TherapySULFURDHC USA Incorporated84d49048-95cf-4f14-9698-c746237fec9d2026-01-24WarningsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE, SULFURSODIUM SULFACETAMIDE 9.8% SULFUR 4.8%Aspen Medical LLC4915e4eb-5307-d2db-e063-6394a90a67b32026-01-23Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Joint Tonic R IGINKGO BILOBA, DIOSCOREA VILLOSA, GLYCYRRHIZA GLABRA, VISCUM ALBUM, PINUS SYLVESTRIS, APIS MELLIFICA, DULCAMARA, KALMIA LATIFOLIA, LYCOPODIUM CLAVATUM, SULPHURBioActive Nutritional, Inc.183e5794-76a4-450f-9686-7828e46855a32026-01-21WarningsExact identifier
unii: 2788Z9758H
unii: 70FD1KFU70
Inflammation IECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEABioActive Nutritional, Inc.3cb12181-ae7e-45c7-a1b1-e1952f36f8c32026-01-21WarningsExact identifier
unii: ZW3Z11D0JV
NeurotoxAGARICUS MUSCARIUS, COCCUS CACTI, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM CERIUM METALLICUM, CESIUM CHLORIDE, CHROMIUM, COBALTUM METALLICUM, CUPRUM METALLICUM, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, EUROPIUM METALLICUM, FERRUM METALLICUM, GADOLINIUM METALLICUM, GERMANIUM SESQUIOXIDE, HOLMIUM METALLICUM,BioActive Nutritional, Inc.73fb4038-40b5-4b5b-8ded-f510d0411c952026-01-21WarningsExact identifier
unii: 27YLU75U4W
Naturasil Mite B Gone EXTREME BATH SOAKSULFURNature's Innovation, Inc.e94a0255-3ec1-4d68-93cf-80d4d7c99f7a2026-01-20WarningsExact identifier
unii: 70FD1KFU70
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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