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 133 of 160 · 3,195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.d29af0e7-0d04-47e3-9a50-d99c7e14b44d2023-02-20WarningsExact identifier
unii: 3SW678MX72
unii: G0R4UBI2ZZ
Natrum muriaticumSODIUM CHLORIDEBoiron1ef4a040-7bee-11e6-8371-424c583030312023-02-20Exact identifier
unii: 451W47IQ8X
Allium cepaONIONBoironc18887f0-794a-11e6-8b60-424c583030312023-02-20Exact identifier
unii: 492225Q21H
Hydrastis canadensisGOLDENSEALBoiron85ba819e-830f-0c84-e053-2991aa0a51182023-02-20Exact identifier
unii: ZW3Z11D0JV
CitriDropsASCORBICUM ACIDUM, CITRUS LIMONUN, PULSATILLA, SINAPIS NIGRA, LUFFA OPERCULATA, BERBERIS VULGARIS, EUPHORBIUM OFFICINARUM, GUAIACUM, HEPAR SULPHURIS CALCAREUM, MERCURIUS SULPHURATU RUBERMicro Balance Health Productsf529aef5-ed57-7b26-e053-2995a90a54302023-02-20WarningsExact identifier
unii: 1MBW07J51Q
Natrum muriaticumSODIUM CHLORIDEBoiron8645e304-a71b-5cba-e053-2a91aa0a2d882023-02-20Exact identifier
unii: 451W47IQ8X
PulsatillaANEMONE PULSATILLABoiron86a81564-7874-6012-e053-2991aa0a846c2023-02-20Exact identifier
unii: I76KB35JEV
SulphurSULFURBoiron8696b1c1-7329-3eed-e053-2991aa0a96172023-02-20Exact identifier
unii: 70FD1KFU70
PulsatillaANEMONE PULSATILLABoiron86a89996-cc63-22d9-e053-2991aa0a26ef2023-02-20Exact identifier
unii: I76KB35JEV
EyeClear ProCALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEASilver Star Brandsf4d4943b-cb78-aa71-e053-2a95a90ac6382023-02-16WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
Derma E Acne Clarifying MaskSULFURderma e55df8fb4-abc3-43fe-b89b-6e7d638b27a62023-02-14WarningsExact identifier
unii: 70FD1KFU70
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESNovel Laboratories, Inc.29d821ff-389c-41fb-8a27-89bd3f022b822023-02-08Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
THROATCALMARISAEMA TRIPHYLLUM ROOT, ATROPA BELLADONNA, MERCURIUS SOLUBILIS, BROMINE, BRYONIA ALBA ROOT, ARNICA MONTANA, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTEDBoironde97d002-de84-bcef-e053-2995a90a319b2023-01-31Exact identifier
unii: I76KB35JEV
HTHYCALCAREA CARBONICA, CALCAREA IODATA, FERRUM IODATUM, FUCUS VESICULOSUS, HEPAR SULPHURIS CALCAREUM, KALI IODATUM, LAPIS ALBUS CALCIUM FLUOSILICATE, ORYCTOLAGUS CUNICULUS (RABBIT) ADRENAL GLAND, ORYCTOLAGUS CUNICULUS (RABBIT) PITUITARY GLAND, ORYCTOLAGUS CUNICULUS (RABBIT) SPLEEN, ORYCTOLAGUS CUNICULUS (RABBIT) THYMUS GLAND, ORYCTOLAGUS CUNICULUS (RABBIT) THYROID GLAND, SPONGIA TOSTASeroyal USA079bede5-f618-03ed-e054-00144ff8d46c2023-01-30WarningsExact identifier
unii: 1MBW07J51Q
Natrum muriaticumSODIUM CHLORIDEBoiron86463b98-58f5-7f65-e053-2a91aa0ad3a22023-01-23Exact identifier
unii: 451W47IQ8X
PhosphorusPHOSPHORUSBoiron86947f1d-f2b1-2a28-e053-2991aa0a67272023-01-23Exact identifier
unii: 27YLU75U4W
PhosphorusPHOSPHORUSBoiron8694ff4d-b056-2ff7-e053-2991aa0a144e2023-01-23Exact identifier
unii: 27YLU75U4W
PhosphorusPHOSPHORUSBoiron869316ef-1547-460e-e053-2a91aa0a27352023-01-23Exact identifier
unii: 27YLU75U4W
PulsatillaANEMONE PULSATILLABoiron86a89996-cc5b-22d9-e053-2991aa0a26ef2023-01-23Exact identifier
unii: I76KB35JEV
PulsatillaANEMONE PULSATILLABoiron86a80207-b86c-07d7-e053-2a91aa0a043f2023-01-23Exact identifier
unii: I76KB35JEV

Reported adverse events (FAERS/openFDA)#

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