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 48 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GermasodeARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, ARSENICUM ALBUM, BELLADONNA, BERBERIS VULGARIS, BORRELIA, CHLAMYDIA, HYDRASTIS CANADENSIS, LACHESIS MUTUS, LYMPHOGRANULOMA, MERCURIUS SOLUBILIS, OOPHORINUM, PHOSPHORUS, PNEUMOCOCCINUM, PYROGENIUM, SILICEA TERRANatural Creations, Inccad24325-e658-4427-a2e7-f821f01111702025-12-12WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
GBLV HPATROPA BELLADONNA, BERBERIS VULGARIS ROOT BARK, MILK THISTLE, CHELIDONIUM MAJUS, CITRULLUS COLOCYNTHIS FRUIT PULP, DIOSCOREA VILLOSA TUBER, GOLDENSEAL, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, ANEMONE PULSATILLA, VERATRUM ALBUM ROOTNatural Creations, Inc.cff4d830-6696-4cde-9cd7-4ce55e28b54b2025-12-12WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: I76KB35JEV
HEADACHE HPSILVER NITRATE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MELILOTUS OFFICINALIS TOP, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SPIGELIA ANTHELMIANatural Creations, Inc.c38b83f0-3918-4ef6-8dfd-48fe438e584a2025-12-12WarningsExact identifier
unii: 451W47IQ8X
ProstoforceARALIA QUINQUEFOLIA, DAMIANA, HYDROCOTYLE ASIATICA, SABAL SERRULATA, THUJA OCCIDENTALIS, PAREIRA BRAVA, CLEMATIS ERECTA, CONIUM MACULATUM, JUNIPERUS VIRGINIANA, PULSATILLA (VULGARIS)BioActive Nutritional, Inc.151fe63b-0dbd-4553-a29b-59af54014dbd2025-12-11WarningsExact identifier
unii: I76KB35JEV
Cell WellCALCIUM CARBONICA,CALCIUM FLUORATUM,CALCIUM PHOSPHORICUM,CALCIUM SULPHURICUM,FERRUM PHOSPHORICUM,KALIUM MURIATICUM,KALIUM PHOSPHORICUM,KALIUM SULPHURICUM,MAGNESIUM CARBONICA,MAGNESIUM PHOSPHORICUM,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAJoyWell Co LLC592c1f48-21c8-4ff5-8818-046662c9effe2025-12-11WarningsExact identifier
unii: 451W47IQ8X
Throat RemedyBELLADONNA 30C, HEAR SULPHURIS CALCAREUM 30C, LACHESIS MUTUS 30C, MERCURIUS SOLUBILIS 30C, PHYTOLACCA DECANDRA 30C, FERRUM PHOSPHORICUM 6X, KALI MURIATICUM 5X, CALCAREA SULPHURICA 6X, STREPTOCOCCINUM 200CJoyWell Co LLC51c00f80-3642-4552-a0f8-02a0f7495cf82025-12-11WarningsExact identifier
unii: 1MBW07J51Q
Kroger HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLKroger Company45b2dd86-7fb0-07bf-e063-6394a90a18842025-12-11WarningsExact identifier
unii: PDC6A3C0OX
SULFACETAMIDE SODIUM, SULFURSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.0ea3cd84-de0f-4981-a420-1d01d1ecd6202025-12-11Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
HemoforceURTICA URENS, FERRUM MURIATICUM, ARANEA DIADEMA, AURUM METALLICUM, CINCHONA OFFICINALIS, COBALTUM GLUCONATE, PHOSPHORUSBioActive Nutritional, Inc.890e095c-aec7-4449-9d8c-140d32c1afb72025-12-11WarningsExact identifier
unii: 27YLU75U4W
DIZZINESS HPOYSTER SHELL CALCIUM CARBONATE CRUDE, CHENOPODIUM AMBROSIOIDES, ANAMIRTA COCCULUS SEED, CONIUM MACULATUM FLOWERING TOP, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PULSATILLA VULGARIS, SILICON DIOXIDENatural Creations, Inc.9701096b-5efa-4acd-9227-339ecedfd6722025-12-10WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
SinuCleanseSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.beb842fa-2373-4f21-9631-ef20ee1245842025-12-10WarningsExact identifier
unii: 451W47IQ8X
All natural Saline Packets CareOneSODIUM BICARBONATE, SODIUM CHLORIDEFOODHOLD U.S.A.e32f105d-65cd-8095-e053-2995a90a9b6b2025-12-10WarningsExact identifier
unii: 451W47IQ8X
FCS HPEPINEPHRINE,GLUTAMICACID,MUCUNAPRURIENSSEED,NIACINAMIDE,SEROTONIN,UBIDECARENONE,CORTICOTROPIN,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATECRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFURNatural Creations, Inc.ba8fed68-f27f-4651-adec-0994a53758872025-12-10WarningsExact identifier
unii: 70FD1KFU70
unii: I76KB35JEV
DIARRHEA CPAETHUSA CYNAPIUM, ARSENIC TRIOXIDE, OYSTER SHELL CALICUM CARBONATE, CRUDE, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, IRON, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLOBILIS, PHOSPHORUS, PODOPHYLLUM, ANEMONE PULSATILLA, DELPHINIUM STRAPHISAGRIA SEED, SULFURNatural Creations, Inc.06f51c41-1e76-4201-937a-cbaaf6a477af2025-12-10WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
unii: I76KB35JEV
DigestionGENTIANA LUT, SAMBUCUS NIG, ARSENICUM ALB, BISMUTH SUB, CARBO VEG, KALI BIC, LYCOPODIUM, NUX VOM, PHOSPHORUS, PULSATILLANatural Creations, Inceabd9ea9-e61d-4c18-b95f-60c9ab1b3dd82025-12-10WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
FCS CPCORTICOTROPIN,GLUTAMICACID,MUCUNAPURIENSSEED,SEROTONIN,EPINEPHRINE,NIACINAMIDE,UBIDECARENONE,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,UNSPECIFIED,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATE,CRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFURNatural Creations, Inccb69e9d6-62a6-4af0-8d2d-1e68b0830a202025-12-10WarningsExact identifier
unii: 70FD1KFU70
unii: I76KB35JEV
TexaClear All Season Allergy ReliefANTIGENS ALL ZONES GRASSES TREES AND WEEDS. BAPTISIA TINCTORIA, ECHINACEA, HYDRASTIS CANADENSIS, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, URTICA URENSGM Pharmaceuticals, INC065d16e7-87f4-ecaa-e063-6294a90abca72025-12-09WarningsExact identifier
unii: ZW3Z11D0JV
TexaClear Texas Allergy Relief plus Cedar FeverANTIGENS ALL ZONES GRASSES TREES AND WEEDS. BAPTISIA TINCTORIA, ECHINACEA, HYDRASTIS CANADENSIS, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, URTICA URENSGM Pharmaceuticals, INC0a5d6aa5-e998-e028-e063-6294a90afde62025-12-09WarningsExact identifier
unii: ZW3Z11D0JV
TexaClear Texas Allergy Relief plus Cedar FeverANTIGENS ALL ZONES GRASSES, TREES, AND WEEDS. BAPTISIA TINCTORIA, ECHINACEA, HYDRASTIS CANADENSIS, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, URTICA URENSGM Pharmaceuticals, INC065d2f3c-dc82-69cb-e063-6394a90a78172025-12-09WarningsExact identifier
unii: ZW3Z11D0JV
Rhinomel ManukaSODIUM CHLORIDEMelcare Biomedical Pty Ltd35a7ce7d-4a26-e3f0-e063-6294a90ad66f2025-12-09WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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