FDA.reportPublic FDA data

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 30 of 163 · 3,252 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ArtalgiaCARDUUS MARIANUS, ARNICA MONTANA, AGARICUS MUSCARIUS, BARYTA CARBONICA, BELLIS PERENNIS, GLONOINUM, HAMAMELIS VIRGINIANATodd Horton DPMc61841db-5a8f-4d36-93bb-19f6c05dd91e2026-01-12WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
Vascu-Pro T009CACTUS GRANDIFLORUS, HAMAMELIS VIRGINIANA, VALERIANA OFFICINALIS, ARTERIA SUIS, HEART (SUIS), ARNICA MONTANA, AURUM METALLICUM, BARYTA MURIATICA, CHOLESTERINUM, LECITHIN, MAGNESIA MURIATICA, OXALICUM ACIDUM, PHOSPHORUSGuangzhou Renuma Medical Systems Co., Ltd01d22fd6-7d2f-4448-81ff-c88baafc0af72026-01-09WarningsExact identifier
unii: 27YLU75U4W
Lung DrainageANTIMONIUM ARSENICICUM, BRYONIA (ALBA), CAMPHORA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CHININUM MURIATICUM, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HAEMOPHILUS INFLUENZAE B, IPECACUANHA, KALI MURIATICUM, LOBELIA PURPURESCENS, LUNG (SUIS), MYCOPLASMA PNEUMONIAE, MYCOPLASMA PNEUMONIAE DNA, OXYGENIUM, PHOSPHORUS, PNEUMOCOCCINUM, SENEGA OFFICINALIS, STANNUM METALLICUM, VERATRUM VIRIDEDeseret Biologicals, Inc.fd109172-46c3-444e-9fa0-124f785c3fb52026-01-09WarningsExact identifier
unii: 27YLU75U4W
YeastCalmSODIUM BORATE,CALENDULA OFFICINALIS FLOWERING TOP,CANDIDA ALBICANS,GOLDENSEALLaboratoires Boirdoncd384b93-b803-8810-e053-2a95a90acdf02026-01-09WarningsExact identifier
unii: ZW3Z11D0JV
ST MORIZ SUNCARE BODY SUNSCREEN SPF30SUNCARE BODY SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.48026f09-6d15-8fa6-e063-6294a90a17cb2026-01-09WarningsExact identifier
unii: PDC6A3C0OX
Bio Galium PhaseAPIS MELLIFICA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALTHA PALUSTRIS, CLEMATIS ERECTA, CORTISONE ACETICUM, ECHINACEA (ANGUSTIFOLIA), GAERTNER BACILLUS (BACH), GALIUM APARINE, HEDERA HELIX, JUNIPERUS COMMUNIS, NITRICUM ACIDUM, ONONIS SPINOSA, PHOSPHORUS, SEDUM ACRE, SEMPERVIVUM TECTORUM, THUJA OCCIDENTALIS, URTICA URENSDeseret Biologicals, Inc.902f38c5-b870-4313-9b0b-e69ca357d8442026-01-09WarningsExact identifier
unii: 27YLU75U4W
Animal Pathogens Nosode Combination 9419ANIMAL PATHOGENS NOSODE COMBINATIONProfessional Complementary Health Formulas43b6ae2d-c089-4b81-bd15-0c66a84bbdbf2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Livestock Nosode Combination 9413LIVESTOCK NOSODE COMBINATIONProfessional Complementary Health Formulasc8c8fd6f-c7be-45f5-9c29-84533b6c21e02026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Hepaticol Drops 5008HEPATICOL DROPSProfessional Complementary Health Formulas79ee9e37-7853-4560-a87d-cdaefb603bbb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Attention Deficit Mild Drops 2146ATTENTION DEFICIT MILD DROPSProfessional Complementary Health Formulas68a65713-da9c-4f13-bc84-e45344b9dc642026-01-08WarningsExact identifier
unii: 27YLU75U4W
Fungus Nosode Combination 9401FUNGUS NOSODE COMBINATIONProfessional Complementary Health Formulasf85fb1bb-a395-45b8-9926-f652919a38302026-01-08WarningsExact identifier
unii: 70FD1KFU70
Sulphur 7138SULPHURProfessional Complementary Health Formulasce520b78-adda-4343-91c0-80d29912db552026-01-08WarningsExact identifier
unii: 70FD1KFU70
RET Stomach 7001RET STOMACHProfessional Complementary Health Formulas086427e0-599e-4405-a996-d949023f9d902026-01-08WarningsExact identifier
unii: 70FD1KFU70
Wet Eczema Drops 2136WET ECZEMA DROPSProfessional Complementary Health Formulas28f08a29-9b1a-4579-a56f-4cab7cdcfcb62026-01-08WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
Female Balance Liquescence 3009FEMALE BALANCE LIQUESCENCEProfessional Complementary Health Formulas1ed04735-32ea-4582-94e2-388e9b540cc12026-01-08WarningsExact identifier
unii: 2788Z9758H
Cerebral Blood Stim Drops 2086CEREBRAL BLOOD STIM DROPSProfessional Complementary Health Formulasee501d10-085e-4051-8702-587d4266cede2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Hepar sulphuris calcareum 7120HEPAR SULPHURIS CALCAREUMProfessional Complementary Health Formulas35d52c82-5800-45ce-8fe3-53148455a2ad2026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Lachesis Combination 9229LACHESIS COMBINATIONProfessional Complementary Health Formulas7301c44c-2460-43ad-9cb2-dffdc8ee423c2026-01-08WarningsExact identifier
unii: 70FD1KFU70
Whole Body Detox Liquescence 3035WHOLE BODY DETOX LIQUESCENCEProfessional Complementary Health Formulasf69b8599-86ed-41fe-8572-b71fa9e243282026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Energy Regulation Combination 9308ENERGY REGULATION COMBINATIONProfessional Complementary Health Formulasb091febb-f18f-46d1-8bb8-d911de4c89352026-01-08WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q

Reported adverse events (FAERS/openFDA)#

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