FDA.reportPublic FDA data

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 121 of 160 · 3,195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SulphurSULFURBoiron8696c9d6-22eb-4eb7-e053-2991aa0abd542023-11-15Exact identifier
unii: 70FD1KFU70
SulphurSULFURBoiron86989825-e2f9-3d46-e053-2991aa0a7e282023-11-15Exact identifier
unii: 70FD1KFU70
Natrum muriaticumSODIUM CHLORIDEBoiron8646d7ea-cf5e-607d-e053-2a91aa0aeca12023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86466121-7217-d053-e053-2a91aa0a8f8a2023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron864669c9-5bdc-232f-e053-2a91aa0a1fc62023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86462e06-d221-36b7-e053-2991aa0a1d822023-11-14Exact identifier
unii: 451W47IQ8X
PhosphorusPHOSPHORUSBoiron8693d143-14cf-5272-e053-2991aa0a2e6c2023-11-14Exact identifier
unii: 27YLU75U4W
PhosphorusPHOSPHORUSBoiron869444f6-a634-03f9-e053-2a91aa0a06322023-11-14Exact identifier
unii: 27YLU75U4W
PulsatillaANEMONE PULSATILLABoiron86a7d960-a22d-ecf9-e053-2a91aa0a41f22023-11-14Exact identifier
unii: I76KB35JEV
PulsatillaANEMONE PULSATILLABoiron86a8ea57-7c9a-b72c-e053-2991aa0ae2c82023-11-14Exact identifier
unii: I76KB35JEV
PulsatillaANEMONE PULSATILLABoiron86a7c4e4-a105-9a2d-e053-2991aa0a33d92023-11-13Exact identifier
unii: I76KB35JEV
GLYCYRRHIZA GLABRAGLYCYRRHIZA GLABRABoiron7d7b46d9-b980-eaf0-e053-2a91aa0ae0f42023-11-13Exact identifier
unii: 2788Z9758H
Gun powderPOTASSIUM NITRATE, ACTIVATED CHARCOAL, SULFURBoirona7aa3ac0-beec-11e7-81f2-424c583030312023-11-13Exact identifier
unii: 70FD1KFU70
Gun powderPOTASSIUM NITRATE, ACTIVATED CHARCOAL, SULFURBoiron85cb268d-43b4-3c6e-e053-2991aa0a050f2023-11-13Exact identifier
unii: 70FD1KFU70
Hepar sulphuris calcareumCALCIUM SULFIDEBoiron85b74120-7d33-eda6-e053-2a91aa0a4c022023-11-13Exact identifier
unii: 1MBW07J51Q
Hepar sulphuris calcareumCALCIUM SULFIDEBoiron85b70a7d-8974-360a-e053-2a91aa0abdef2023-11-13Exact identifier
unii: 1MBW07J51Q
The INKEY List Acne Clearing MoisturizerSULFURBrand Evangelists for Beauty Limitedd26f5031-6592-4467-afc9-41c21f9f048c2023-11-10WarningsExact identifier
unii: 70FD1KFU70
Throat CareECHINACEA, ACONITUM NAP., APIS MEL., ARUM DRAC., BELLADONNA, BRYONIA, CAJUPUTUM, FERRUM PHOS., GLYCYRRHIZA, KALI BIC., LACHESIS, MENTA PIP., MERC. VIV., NAJA, NAT. CARB., NAT SULPHURICUM, NITRICUM AC., NUX VOM., PHOS., PHYTOLACCA, PULSATILLA, SPONGIA, STANNUM MET., STICTA, THUJA OCC., ULMUS FULV., VERBASCUMNewton Laboratories, Inc.99eb7b5d-926d-aa16-e053-2a95a90a08342023-11-07WarningsExact identifier
unii: 27YLU75U4W
unii: 2788Z9758H
unii: I76KB35JEV
CV TOXCOCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS BOVINE, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, MORBILLINUM, POLIOMYELITIS NOSODE, HEPATITIS B NOSODE, COXSACKIE B1 NOSODE, CYTOMEGALOVIRUS NOSODE, COXSACKIE B4 NOSODE, EPSTEIN BARR VIRUS NOSODEBioActive Nutritional, Inc.8ef2fb5c-1b24-46a1-8d21-a78ce0a34a872023-11-07WarningsExact identifier
unii: ZW3Z11D0JV
Oligo Bio IodineCHELIDONIUM MAJUS, IODIUM, LYCOPUS VIRGINICUS, GINKGO BILOBA, PINUS SYLVESTRIS, FUCUS VESICULOSUS, SPONGIA TOSTA, GERMANIUM SESQUIOXIDE, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), CYSTEINUM, MANGANESE GLUCONATE, ALPHA-KETOGLUTARICUM ACIDUM, CALCAREA CARBONICA, FERRUM IODATUM, FUMARICUM ACIDUM, KALI IODATUM, NATRUM OXALACETICUM, PULSATILLA (VULGARIS), ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, EUGENOL, FORMALINUM, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM METALLICUM, NICCOLUM METALLICUM,BioActive Nutritional, Inc.90e3028e-9e1e-4887-8b7c-f712bf67cd522023-11-07WarningsExact identifier
unii: I76KB35JEV

Reported adverse events (FAERS/openFDA)#

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