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 130 of 160 · 3,195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ReboostACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GOLDENSEAL, LACHESIS MUTA VENOM, PHOSPHORUS, VINCETOXICUM HIRUNDINARIA ROOT, ZINC GLUCONATE, ZINC ACETATE ANHYDROUS, CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE, IPECAC, SULFURMediNatura Inc.781c1a63-5210-4069-8427-bc7df68d6d632023-06-05WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: 70FD1KFU70
Allergen IIPOTASSIUM GLUCONATE, ADRENALINUM, HEPAR BOVINE, ARSENICUM ALBUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SULPHUR, AMBROSIA ARTEMISIAEFOLIA, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, HISTAMINUM HYDROCHLORICUMBioActive Nutritional, Inc.2140b105-60d6-4b52-82f5-407211fd69332023-06-05WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
SulfurSULFURTrue Botanica, LLC6198f81e-c76f-9f38-e053-2a91aa0a52c32023-06-02WarningsExact identifier
unii: 70FD1KFU70
LY-COANGELICA ARCHANGELICA, KALI MURIATICUM, YUCCA FILAMENTOSA, CARTILAGO SUIS, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, RHUS TOX, CAUSTICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, OXALICUM ACIDUM, ARNICA MONTANA, BORRELIA BURGDORFERI NOSODE, LATRODECTUS MACTANS, CITRICUM ACIDUM, CYTOMEGALOVIRUS NOSODE, RICKETTSIA NOSODE (RICKETTSIA PROWAZEKII), CHLAMYDIA TRACHOMATIS, LEDUM PALUSTREBhp Holdings, Inc.47140966-5b49-432d-bf35-bcae14f420822023-06-01WarningsExact identifier
unii: ZW3Z11D0JV
Lyme and Co-Infection NosodeANGELICA ARCHANGELICA, KALI MURIATICUM, YUCCA FILAMENTOSA, CARTILAGO SUIS, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, RHUS TOX, CAUSTICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, OXALICUM ACIDUM, ARNICA MONTANA, BABESIA MICROTI, BORRELIA BURGDORFERI NOSODE, LATRODECTUS MACTANS, CITRICUM ACIDUM, CYTOMEGALOVIRUS NOSODE, RICKETTSIA NOSODE (RICKETTSIA PROWAZEKII), CHLAMYDIA TRACHOMATIS, LEDUM PALUSTREBhp Holdings, Inc.f6186157-256f-4454-b122-f7665e3286f42023-06-01WarningsExact identifier
unii: ZW3Z11D0JV
Cyclease PMSESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICELaboratoires Boiron09ff0633-2992-4aba-96ed-45a69f3ee5892023-05-30WarningsExact identifier
unii: 451W47IQ8X
Cold ArmorALLIUM CEPA, HYDRASTIS CANADENSIS, PULSATILLA (PRATENSIS), DULCAMARA, NUX VOMICA, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, KALI BICHROMICUMRatis, LLC46af3f19-055e-4025-a14e-1d6c25880f4d2023-05-26WarningsExact identifier
unii: 492225Q21H
unii: ZW3Z11D0JV
BHI BackAMMONIUM CHLORIDE, MATRICARIA RECUTITA,CITRULLUS COLOCYNTHIS FRUIT PULP, PSEUDOGNAPHALIUM OBTUSIFOLIUM, AND TOXICODENDRON PUBESCENS LEAFMediNatura Incaa622a5b-16de-4098-9c3f-d7569f7d2c2f2023-05-23WarningsExact identifier
unii: G0R4UBI2ZZ
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEMedical Purchasing Solutions, LLC8a0d24a9-d02a-0379-e053-2a95a90af7122023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PhosphorusPHOSPHORUSBoiron869487ce-076b-7927-e053-2a91aa0a83db2023-05-16Exact identifier
unii: 27YLU75U4W
Histastat PollenBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDESEnergique, Inc.00478787-ccec-4101-a0da-fd337037c3ee2023-05-12WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: 492225Q21H
unii: 70FD1KFU70
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium Sulfacetamide 9.8 % and Sulfur 4.8 % CleanserSODIUM SULFACETAMIDE AND SULFURSOHM, Inc67d67324-ff2d-4d5b-8bc5-308c6f4522f52023-05-03Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 10 % and Sulfur 2 % CleanserSODIUM SULFACETAMIDE AND SULFURSOHM, Inc480b4c92-45a1-4ac8-83ee-791abf1b87592023-05-03Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Natrum MuriaticumNATRIUM MURIATICUMTrue Botanica, LLC7d2d9129-8683-484d-e053-2a91aa0a6f8f2023-05-01WarningsExact identifier
unii: 451W47IQ8X
Hepar SulfHEPAR SULFTrue Botanica, LLC5e75952a-f7f1-d2e7-e053-2a91aa0a85d72023-05-01WarningsExact identifier
unii: 1MBW07J51Q
Sodium Sulfacetamide 10 % and Sulfur 5 % CleanserSODIUM SULFACETAMIDE AND SULFURSOHM, Incdc4f3e25-a39d-4965-80e8-4fe2361a67d02023-04-30Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Thyroid SarcodeCALCAREA IODATA, FUCUS VESICULOSUS, GLANDULA SUPRARENALIS (BOVINE), HYPOPHYSIS SUIS, KALI IODATUM, SPLEEN (BOVINE), SPONGIA TOSTA, THYMUS (BOVINE), THYROIDINUM (BOVINE), CALCAREA CARBONICA, HEPAR SULPHURIS CALCAREUM, LAPIS ALBUSNutritional Specialties, Inc.79f4767a-2b32-4a8a-9af3-109dd86130902023-04-24WarningsExact identifier
unii: 1MBW07J51Q
Histapoll HPALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, APIS MELLFICA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, NUX VOMICA, PHOSPHORUS, PULSATILLA (VULGARIS), SOLIDAGO VIRGAUREA, SULPHUREnergique, Inc.09a75182-6939-4e2b-a61a-9c58c9e9284e2023-04-21WarningsExact identifier
unii: 27YLU75U4W
unii: 492225Q21H
unii: 70FD1KFU70
unii: I76KB35JEV

Reported adverse events (FAERS/openFDA)#

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