FDA.reportPublic FDA data

NDC 54973-3379-01 - 4 Kids Cold and Cough Day and Night 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
54973-3379
Requested NDC
54973-3379-01
Package NDCs from labels
54973-3379-1, 54973-3379-01
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 'n Cough Day & Night Combo Pack Grape FlavorHyland's Inc.2025-12-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3243-14 Kids Cold and Cough Day and Night Grape Flavor1 in 1 CARTONLIQUID6 [hp_X] in 1mL11
54973-3243-14 Kids Cold and Cough Day and Night Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID118 mL6 [hp_X] in 1mL11
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
54973-3379-14 Kids Cold and Cough Day and Night Grape Flavor1 in 1 CARTONKIT111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-33794 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 NDC, 5 package rows20250502_79f26bb5-15ad-e40a-e053-2991aa0aaab3.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 38 of 160 · 3,196 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough Drops 2014COUGH DROPSProfessional Complementary Health Formulas533c8124-d8bc-404a-9f1f-680d7ef8eb362026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Anti-Inflammation Drops 2005ANTI-INFLAMMATION DROPSProfessional Complementary Health Formulas66c901e0-9489-423b-98ef-c9fc517b5bd22026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Aesculus Combination 9202AESCULUS COMBINATIONProfessional Complementary Health Formulas5318d83a-2d8f-4ecc-80ac-d191be5f198f2026-01-08WarningsExact identifier
unii: 70FD1KFU70
Herbal Diuretic Liquescence 3011HERBAL DIURETIC LIQUESCENCEProfessional Complementary Health Formulas5eee7f21-a3c4-46e0-a642-a4ca635734e32026-01-08WarningsExact identifier
unii: 451W47IQ8X
Proactiv Clean Mineral Acne CleanserSULFURAlchemee, LLC380d0f8f-8d31-41b9-9d5f-8a35f7f81b5b2026-01-07WarningsExact identifier
unii: 70FD1KFU70
Proactiv Skin Purifying MaskSULFURTHE PROACTIV COMPANY LLC9f0eb12b-4da1-4498-9ffb-de8235264d9b2026-01-07WarningsExact identifier
unii: 70FD1KFU70
Earths Care Acne Treatment MaskSULFURDLC Laboratories, Inc.f067e85e-0475-4108-ad93-2af7717ead3e2026-01-07WarningsExact identifier
unii: 70FD1KFU70
Acne Treatment with SulfurSULFURDLC Laboratories, Inc.aa1f2afe-7b09-4448-b522-e1b23d63d3ef2026-01-07WarningsExact identifier
unii: 70FD1KFU70
Sodium chlorideSODIUM CHLORIDEBECTON DICKINSON AND COMPANYd39b7307-df67-4e68-acb0-2eda5dc612152026-01-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.ff95b833-3760-4e34-9636-90b423fc0d7b2026-01-07WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: 70FD1KFU70
ColostatRHAMNUS PURSHIANA, SPIGELIA ANTHELMIA, TARAXACUM OFFICINALE, CAJUPUTUM, HYDRASTIS CANADENSIS, ALOE, ALUMINA, CINA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUMEnergique, Inc.3ddbed50-7ca9-493c-ba94-321c2afef60e2026-01-06WarningsExact identifier
unii: ZW3Z11D0JV
Proctozone-GGLYCERINRising Pharma Holdings, Inc.8a5c8ad5-3619-4971-967d-165270a20bc82026-01-06WarningsExact identifier
unii: PDC6A3C0OX
Proctozone GMaxGLYCERINRising Pharma Holdings, Inc.a13c2be6-d650-4b53-bddd-d55e92fe10c62026-01-06WarningsExact identifier
unii: PDC6A3C0OX
Multi Food AntigensARSENICUM ALBUM, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), ALLIUM CEPA, ALLIUM SATIVUM, ALMOND, APIUM GRAVEOLENS, BETA VULGARIS, BRASSICA OLERACEA VAR. ITALICA, BRAZIL, CACAO, CAPSICUM ANNUUM, CASHEW, CICER ARIETINUM, CITRUS LIMONUM, COCONUT, COFFEA TOSTA, COLLAGEN, CORN, CUCUMIS SATIVUS, ENGLISH WALNUT, GLYCINE MAX, HEART (BOVINE), HEART (SUIS), LAC VACCINUM, LACTUCA SATIVA, LYCOPERSICUM ESCULENTUM, ORANGE, OXALICUM ACIDUM, PEANUT, PECAN, PHASEOLUS, PHASEOLUS VULGARIS, RAPHANUS SATIVUS, SESAME,Energique, Inc.a289e8a7-1188-43be-b34b-fe6d5ee09d1c2026-01-06WarningsExact identifier
unii: 492225Q21H
Good Sense Hemorrhoidal Maximum Strength Pain ReliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUML. Perrigo Company1d6142b6-3746-46f1-99ec-4b19d26f056e2026-01-06WarningsExact identifier
unii: PDC6A3C0OX
Joesoef Skincare Anti AcneSULFURPT Galenium Pharmasia Laboratoriesd9b7acd4-f0dd-c28b-e053-2a95a90a4c302026-01-05WarningsExact identifier
unii: 70FD1KFU70
Sting Relief prep PadSTING RELIEF PREP PADSHENZHEN BENLIJU BIO-TECH CO.,LTD202c7b77-1a48-52a5-e063-6394a90a2eb22026-01-05WarningsExact identifier
unii: PDC6A3C0OX
Skin Cleaning Care WipesSKIN CLEANING CARE WIPESSHENZHEN BENLIJU BIO-TECH CO.,LTD203d7a95-65fe-ca65-e063-6294a90acc6e2026-01-05WarningsExact identifier
unii: PDC6A3C0OX
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.64a99cd3-341a-44ec-b4eb-c06982e6d4142026-01-05WarningsExact identifier
unii: 27YLU75U4W
Jointox BBBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, BORRELIA BURGDORFERI NOSODE, BABESIA MICROTI, EHRLICHIA NOSODE (CANINE), HEPATITIS B NOSODE, MENINGOCOCCUS NOSODE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BRYONIA (ALBA), CHELIDONIUM MAJUS, COLCHICUM AUTUMNALE, KALMIA LATIFOLIA, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, PHOSPHORUS, RHUS TOXEnergique, Inc.2f8f13cc-5c16-4ce4-952f-43df61fda8c92026-01-05WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV

Reported adverse events (FAERS/openFDA)#

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