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 159 of 160 · 3,181 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Teething-HPBORAX, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, PASSIFLORA INCARNATA, PODOPHYLLINUM, SILICEABioActive Nutritional, Inc.1758624d-7ed8-49a6-ab24-2aab57703c912017-06-16WarningsExact identifier
unii: G0R4UBI2ZZ
IndustrotoxGLYCYRRHIZA GLABRA, PLANTAGO MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ARNICA MONTANA, ASCLEPIAS TUBEROSA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, LAPPA MAJOR, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, XANTHOXYLUM FRAXINEUM, SYMPHYTUM OFFICINALE, HEPAR SUIS, LUNG (SUIS), LYMPH NODE (SUIS)BioActive Nutritional, Inc.0722085a-1478-4667-b0c6-3315cff25b082017-06-16WarningsExact identifier
unii: 2788Z9758H
unii: G0R4UBI2ZZ
FIND BICHON CLEANSING MASKGLYCERINPioom Cosmetic Co.,ltd50b7db48-7b55-6df4-e054-00144ff88e882017-05-30WarningsExact identifier
unii: PDC6A3C0OX
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company886f889b-f3cf-4197-b307-6cfa88c894362017-05-04Exact identifier
unii: 451W47IQ8X
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Senility HPANACARDIUM ORIENTALE, BELLADONNA, HYOSCYAMUS NIGER, VERATRUM ALBUM, BARYTA CARBONICA, LACHESIS MUTUS, PHOSPHORUS, STRAMONIUMBioActive Nutritional, Inc.214cf942-5277-4f4b-af7d-a9fcc6c8bd372017-02-23WarningsExact identifier
unii: 27YLU75U4W
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corp9883c502-9782-451e-9eec-c54d7b054f312017-01-31WarningsExact identifier
unii: 3SW678MX72
unii: 451W47IQ8X
Estrogen and ProgesteroneAGNUS CASTUS, ANGELICA SINENSIS, APIS MELLIFICA, ARNICA MONTANA, CIMICIFUGA RACEMOSA, ESTRADIOL, ESTRIOL, FOLLICULINUM, GALIUM APARINE, GLYCYRRHIZA GLABRA, KOREAN GINSENG, OOPHORINUM (SUIS), PROGESTERONE, SEPIA, THUJA OCCIDENTALIS, VISCUM ALBUMProBLEN71fec93b-43b7-4ebb-ab5c-5f544d8e6cbf2017-01-12WarningsExact identifier
unii: 2788Z9758H
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: I76KB35JEV
Inflammation IIASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), SARSAPARILLA (SMILAX REGELII), TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, THYROIDINUM (SUIS), AURUM METALLICUM, CARBO ANIMALIS, CAUSTICUM, GELSEMIUM SEMPERVIRENS, NATRUM SULPHURICUM, PHOSPHORUS, SULPHUR, THUJA OCCIDENTALISBioActive Nutritional, Inc.4c36e714-f564-41d3-a6b8-60e633defaff2016-10-04WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: 70FD1KFU70
Food AdditivesBERBERIS VULGARIS, CHELIDONIUM MAJUS, TRIFOLIUM PRATENSE, GLYCYRRHIZA GLABRA, LAPPA MAJOR, PHYTOLACCA DECANDRA, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, XANTHOXYLUM FRAXINEUM, ARSENICUM ALBUM, BELLADONNA, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUMBioActive Nutritional, Inc.bf27d457-12e1-4ab6-b132-1b65cde0ed932016-09-28WarningsExact identifier
unii: 2788Z9758H
Enuresis HPARGENTUM NITRICUM, BELLADONNA, CAUSTICUM, EQUISETUM HYEMALE, KREOSOTUM, NITRICUM ACIDUM, PULSATILLA (VULGARIS), THUJA OCCIDENTALISBioActive Nutritional, Inc.a6fff9be-e78d-4539-b741-6a8080a164a02016-09-07WarningsExact identifier
unii: I76KB35JEV
ThyrotoxCHONDRUS CRISPUS, FUCUS VESICULOSUS, THYROIDINUM, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, IODIUM, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEABioActive Nutritional, Inc.e229a260-13f3-4136-b325-9a8954f8a3272016-08-10WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
TeethingARNICA MONTANA, TRIFOLIUM PRATENSE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, KREOSOTUM, SILICEABioActive Nutritional, Inc.f39c9feb-f567-43a2-a026-2a581aeeed9d2016-07-27WarningsExact identifier
unii: G0R4UBI2ZZ
CerebroforceCAPSICUM ANNUUM, GINKGO BILOBA, GELSEMIUM SEMPERVIRENS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, ARSENICUM ALBUMBioActive Nutritional, Incf998ed3f-56a5-4497-be5b-9a819fe8be692016-07-13WarningsExact identifier
unii: 27YLU75U4W
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation2a96096d-43cc-49b7-af53-b53c17f410012014-07-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporationb3b4b176-41f0-4ca8-90d4-3fba5707564a2014-02-21Exact identifier
unii: 451W47IQ8X
TIS-U-SOLSODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATEBaxter Healthcare Corporation9da4121f-d62d-4da4-8dfb-0494da16015f2014-02-21Exact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,Baxter Healthcare Corporatione1953d54-818d-46a6-8532-518ebae6d84e2012-06-13Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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