FDA.reportPublic FDA data

NDC 54973-3400-01 - 4 Kids Cold and Cough Daytime

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
54973-3400
Requested NDC
54973-3400-01
Package NDCs from labels
54973-3400-1, 54973-3400-01
Manufacturer
Hyland's Inc. | LGM Pharma Solutions, LLC
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
4 Kids Cold and Cough Daytime - Hyland's Inc. | LGM Pharma Solutions, LLCHyland's Inc. | LGM Pharma Solutions, LLC2025-12-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3400-14 Kids Cold and Cough Daytime1 in 1 CARTONLIQUID14
54973-3400-14 Kids Cold and Cough Daytime148 mL in 1 BOTTLE, PLASTICLIQUID1484

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-34004 KIDS COLD AND COUGH DAYTIME (ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL) LIQUID [HYLAND'S INC.]3Current NDC, Legacy NDC, 2 package rows20221119_804e0e7a-20eb-128b-e053-2991aa0aa82c.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 2 of 157 · 3,132 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and Flu ReliefACONITUM NAPELLUS, ALLIUM CEPA, ECHINACEA (ANGUSTIFOLIA), EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, SANGUINARIA CANADENSIS, STICTA PULMONARIANaturalCare681e553d-3f0a-400f-8611-18ca58b3d8802026-08-27WarningsExact identifier
unii: 492225Q21H
DetoxBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, SARSAPARILLA (SMILAX REGELII), GELSEMIUM SEMPERVIRENS, VERATRUM ALBUM, FERRUM METALLICUM, IODIUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PULSATILLA (VULGARIS), SELENIUM METALLICUM, THUJA OCCIDENTALIS, ZINCUM METALLICUMPro Weight Loss Inc.dbf87fe8-e7c4-4d6f-b55f-da23fcad355e2026-08-26WarningsExact identifier
unii: I76KB35JEV
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
unii: 451W47IQ8X
Electrolyte PlusKALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUMDeseret Biologicals, Inc.e3564733-8b88-4753-9077-9d74004d8ec92026-08-25WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hylands Naturals Earache DropsBELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFURHyland's Inc.017ed754-9fe8-2cb5-e063-6294a90ab2f62026-08-24WarningsExact identifier
unii: 70FD1KFU70
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
Cold Crush AdultACONITUM NAPELLUS, ALLIUM CEPA, BRYONIA ALBA, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, NUX VOMICA, PULSATILLA, RHUS TOXICODENDRON, SABADILLAGenexa Inc.78ff93d3-5c77-b951-e053-2a91aa0adda92026-08-22WarningsExact identifier
unii: 492225Q21H
Genexa Kids Allergy CareALLIUM CEPA, DULCAMARA, EUPHRASIA OFFICINALIS, NUX VOMICA, PULSATILLA, ROSA DAMASCENA, SABIDILLA, SINAPIS NIGRA, WYETHIA HELENOIDESGenexa Inc.ba0da07a-107b-2c66-e053-2995a90ab96a2026-08-22WarningsExact identifier
unii: 492225Q21H
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsExact identifier
unii: 451W47IQ8X
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e882026-08-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sinusforce-HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.53c96680-210b-4426-8b41-3b9a882848dd2026-08-20WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: 1MBW07J51Q
Naturasil Tinea Versicolor ReliefSULFURNature's Innovation, Inc.255f4fdb-bcc5-45e2-b9bd-06908bfbe23b2026-08-19WarningsExact identifier
unii: 70FD1KFU70
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLCdf18a603-ca12-4b26-83b5-9dd07b6453ab2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Light Legs Heavy LegsAESCULUS HIPPOCASTANUM 3C, CARDUUS MARIANUS 3C, HAMAMELIS VIRGINIANA 3C, PULSATILLA 9CSEVENE USA55007136-0f26-0ca5-e063-6394a90a1d242026-08-18WarningsExact identifier
unii: I76KB35JEV
Comfort Down There HemorrhoidsAESCULUS HIPPOCASTANUM 5C, ALOE 5C, BERBERIS VULGARIS 3C, CAPSICUM ANNUUM 5C, CARDUUS MARIANUS 3C, NUX VOMICA 5C, PULSATILLA 9CSEVENE USA55001764-8bc9-cbac-e063-6394a90a455c2026-08-18WarningsExact identifier
unii: I76KB35JEV

Reported adverse events (FAERS/openFDA)#

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