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 132 of 160 · 3,195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrastis canadensisGOLDENSEALBoiron85b9e0fc-cb66-4f3b-e053-2a91aa0a59972023-03-27Exact identifier
unii: ZW3Z11D0JV
PhosphorusPHOSPHORUSBoiron869461fe-6993-55c5-e053-2a91aa0a1a732023-03-27Exact identifier
unii: 27YLU75U4W
Hepar sulphuris calcareumCALCIUM SULFIDEBoiron85b6aeb0-70bb-6940-e053-2a91aa0a818a2023-03-27Exact identifier
unii: 1MBW07J51Q
Hepar sulphuris calcareumCALCIUM SULFIDEBoiron85b63e5f-f475-8fd1-e053-2991aa0a7c102023-03-27Exact identifier
unii: 1MBW07J51Q
Spleen Thymus LiquescenceCINCHONA OFFICINALIS, QUERCUS GLANDIUM SPIRITUS, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), THYMUS (BOVINE), CHININUM ARSENICOSUM, NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.bc1cc31e-0e8a-49a2-9654-f00eaa72fc042023-03-24WarningsExact identifier
unii: 451W47IQ8X
T-ReliefARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Inc2bd442ca-0bbe-0bc3-e054-00144ff8d46c2023-03-21WarningsExact identifier
unii: G0R4UBI2ZZ
Metabolic Correction BlendFOENICULUM VULGARE, AMMONIUM BROMATUM, FUCUS VESICULOSUS, LECITHIN (DERIVED FROM EGG), CAPSICUM ANNUUM, GALIUM APARINE, HYPOTHALAMUS SUIS, KALI BICHROMICUM, LAC DEFLORATUM (NSPC), PHYTOLACCA DECANDRA, PROGESTERONE, THYROIDINUM (BOVINE), PITUITARUM POSTERIUM (BOVINE), ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, CALCAREA CARBONICA, FERRUM METALLICUM, GRAPHITES, ADRENALINUM, PHOSPHORUSIHA Distribution, LLCe8ec4f7e-c9dd-46dd-a9ee-2b8b7bcea9a82023-03-21WarningsExact identifier
unii: 27YLU75U4W
TraumedARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Inc8cd4745f-2f4b-4cdf-868b-c5a089a165992023-03-21WarningsExact identifier
unii: G0R4UBI2ZZ
TraumexARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Inc335c8bec-f0c3-4b95-a6a6-5fda262be0e62023-03-20WarningsExact identifier
unii: G0R4UBI2ZZ
Myco Immuno NosodeDU HUO (ANGELICA PUBESCENS), ANGELICA ARCHANGELICA, KALI MURIATICUM, RADIX SILERIS (SAPOSHNIKOVIA DIVARICATA), YUCCA FILAMENTOSA, ACHYRANTHES BIDENTATA, ANGELICA SINENSIS, LIGUSTICUM PORTERI, PANAX GINSENG, RHUS TOX, HYDRASTIS CANADENSIS, UNCARIA TOMENTOSA, CARTILAGO SUIS, HORDEUM VULGARE, OXALICUM ACIDUM, ARNICA MONTANA, LATRODECTUS MACTANS, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, BORRELIA BURGDORFERI, BABESIA MICROTINutritional Specialties, Inc.34dc93af-0c39-4e06-a8d6-9e1ccc77aa232023-03-17WarningsExact identifier
unii: ZW3Z11D0JV
365 Everyday Value Be Well Cough EaseANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, PROTORTONIA CACTI, DROSERA ROTUNDIFOLIA, IPECAC, PULSATILLA VULGARIS, RUMEX CRISPUS ROOT, PONGIA OFFICINALIS SKELETON, ROASTED, LOBARIA PULMONARIAWFM Private Label, LPd03ce312-2c79-4cc3-b6bf-3965aac136102023-03-16Exact identifier
unii: I76KB35JEV
PulsatillaANEMONE PULSATILLABoiron86a8ba2f-b9be-3f96-e053-2a91aa0ad64e2023-03-16Exact identifier
unii: I76KB35JEV
NS SupportBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS SUIS, PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUM,Dr. Donna Restivo DC807fd9cf-13d1-4173-a6da-180f89b67cf22023-03-15WarningsExact identifier
unii: 70FD1KFU70
SulphurSULFURBoiron8696ff13-5c36-0ecc-e053-2991aa0aff622023-03-09Exact identifier
unii: 70FD1KFU70
SulphurSULFURBoiron869735c4-f8d6-1b5b-e053-2a91aa0a59202023-03-09Exact identifier
unii: 70FD1KFU70
TraumeelACONITUM NAPELLUS, ARNICA MONTANA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALCIUM SULFIDE, HYPERICUM PERFORATUM, MERCURIUS SOLUBILIS, ACHILLEA MILLEFOLIUM AND COMFREY ROOTBiologische Heilmittel Heel9ff5c743-0e8f-4416-9964-c92b3abb54dd2023-03-06WarningsExact identifier
unii: G0R4UBI2ZZ
unii: 1MBW07J51Q
Clearlife Extra StrengthONION, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SULFUR, AMBROSIA ARTEMISIIFOLIA WHOLE, EUPHRASIA STRICTA AND SCHOENOCAULON OFFICINALE SEEDMediNatura Inc.09fbebf9-3d8b-479c-80f3-37f07cb699d62023-03-06WarningsExact identifier
unii: 492225Q21H
unii: 70FD1KFU70
PhosphorusPHOSPHORUSBoiron86936ee2-fbd5-ebe3-e053-2a91aa0a83a32023-03-03Exact identifier
unii: 27YLU75U4W
Insulin Diluting Medium for NovoLogWATER INJECTIONNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Otix Ear Relief Ear DropsCHAMOMILE, MERCURIUS SOLUBILIS, SULFURBell Pharmaceuticals, Inc.229648d3-a0b8-415c-8b07-a514464286842023-02-24WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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