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 84 of 163 · 3,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a27a71-b7b2-12aa-e063-6294a90a312f2025-01-15WarningsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a7720f-1e74-7578-e063-6394a90a5eae2025-01-15WarningsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78060-7f0d-c4bd-e063-6294a90ae1522025-01-15WarningsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78a5c-e3b5-f362-e063-6394a90a08072025-01-15WarningsExact identifier
unii: 2968PHW8QP
CeleragesicECHINACEA (ANGUSTIFOLIA), CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA PURPUREA, BELLIS PERENNIS, CHAMOMILLA, HYPERICUM PERFORATUM, MILLEFOLIUM, LEDUM PALUSTRE, ARNICA MONTANA, BRYONIA (ALBA), NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALE, RHUS TOX, ACONITUM NAPELLUS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUMDeseret Biologicals, Inc.1a3edb9d-e571-4275-b56e-d2489da11e762025-01-14WarningsExact identifier
unii: G0R4UBI2ZZ
unii: 1MBW07J51Q
SLMD Silver Sulfur Acne CreamSULFUROwen Biosciences Inc.4735a6d6-bf87-404d-a46d-7f29fcff94092025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-4QUININE ARSENITE, PHOSPHORIC ACID, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, MERCURIC CHLORIDE, VERATRUM ALBUM ROOT, BAPTISIA TINCTORIA, FERROSOFERRIC PHOSPHATE, NERIUM OLEANDER LEAF, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.45577059-73f4-4302-b299-3e356aaf959a2025-01-13WarningsExact identifier
unii: G0R4UBI2ZZ
D-8SPONGIA OFFICINALIS SKELETON, ROASTED, CAUSTICUM, LACHESIS MUTA VENOM, CALCIUM SULFIDE, THYMUS SERPYLLUM, ANTIMONY POTASSIUM TARTRATE, ACONITUM NAPELLUS, AND DROSERA ROTUNDIFOLIADNA Labs, Inc.bc817ccf-f11c-4875-9e14-5a249f92c5032025-01-13WarningsExact identifier
unii: 1MBW07J51Q
D-34OYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, CALCIUM HYPOPHOSPHITE, TRIBASIC CALCIUM PHOSPHATE, HEKLA LAVA, DAPHNE MEZEREUM BARK, MERCURIC OXIDE, SILICON DIOXIDE, AND MATRICARIA CHAMOMILLADNA Labs, Inc.607e21a3-2229-48fa-b12c-ebd3130b99962025-01-13WarningsExact identifier
unii: G0R4UBI2ZZ
D-5SILVER NITRATE, STRYCHNOS NUX-VOMICA SEED, LYCOPODIUM CLAVATUM SPORE, SEMECARPUS ANACARDIUM JUICE, SCROPHULARIA NODOSA, ATROPA BELLADONNA, ARSENIC TRIOXIDE, ACTIVATED CHARCOAL, MATRICARIA CHAMOMILLA, AND CHELIDONIUM MAJUSDNA Labs, Inc.c286e9b3-51c6-4633-aef1-cda2505c1fa02025-01-13WarningsExact identifier
unii: G0R4UBI2ZZ
D-13HORSE CHESTNUT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, PAEONIA OFFICINALIS ROOT, STRYCHNOS NUX-VOMICA SEED, GRAPHITE, SULFUR, COLLINSONIA CANADENSIS ROOT, POTASSIUM CARBONATE, LYCOPODIUM CLAVATUM SPORE, AND NITRIC ACIDDNA Labs, Inc.047a2c0e-9b59-45c3-85df-0a26cdc397192025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-36AMANITA MUSCARIA FRUITING BODY, STRYCHNOS IGNATII SEED, LACHESIS MUTA VENOM, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, PHOSPHORUS, AND ZINC VALERATE DIHYDRATEDNA Labs, Inc.0c658eda-70eb-4322-ade4-2ec7d7690aeb2025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-12POTASSIUM IODIDE, CALCIUM IODIDE, ARSENIC TRIIODIDE, BARIUM CHLORIDE DIHYDRATE, NITROGLYCERIN, CONIUM MACULATUM FLOWERING TOP, ARNICA MONTANA, PHOSPHORUS, AND GOLD TRICHLORIDEDNA Labs, Inc.cd69e429-32af-4d77-9ec1-c40cfc7fe4142025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-9CUPRIC ACETATE, IPECAC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, DROSERA ROTUNDIFOLIA, ATROPA BELLADONNA, HYOSCYAMUS NIGER, ONION, CORALLIUM RUBRUM EXOSKELETON, AND LOBARIA PULMONARIADNA Labs, Inc.15cb964d-086f-40a6-8056-5f149f04ab4c2025-01-13WarningsExact identifier
unii: 492225Q21H
D-43ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, BOS TAURUS PITUITARY GLAND, POSTERIOR, SODIUM SULFATE, VERATRUM ALBUM ROOT, ERIODICTYON CALIFORNICUM LEAF, SODIUM CHLORIDE, AND DIBASIC POTASSIUM PHOSPHATEDNA Labs, Inc.937e2b7e-4001-402f-bd12-dcff4627e9282025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-38APIS MELLIFERA, APIS MELLIFERA VENOM, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, AND SULFURDNA Labs, Inc.5fff6e4f-a7a4-4975-a8ad-5a3b4685f4aa2025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-25CHIMAPHILA UMBELLATA, CLEMATIS RECTA FLOWERING TOP, POPULUS TREMULA WHOLE, ANEMONE PRATENSIS, SAW PALMETTO, CHONDRODENDRON TOMENTOSUM ROOT, SULFUR, CONIUM MACULATUM FLOWERING TOP, AND FERRIC PICRATEDNA Labs, Inc.1190f58c-4b20-42e7-a2f8-2942e266dff22025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-41PHOSPHORIC ACID, CHASTE TREE, CINCHONA OFFICINALIS BARK, TURNERA DIFFUSA LEAFY TWIG, PHOSPHORUS, SEPIA OFFICINALIS JUICE, BOS TAURUS TESTICLE, AND CONIUM MACULATUM FLOWERING TOPDNA Labs, Inc.3600d04a-bab5-440a-a2aa-908bf920620a2025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-78HYPERICUM PERFORATUM, LACHESIS MUTA VENOM, LYTTA VESICATORIA, ECHINACEA ANGUSTIFOLIA, SODIUM CHLORIDE, AND PLANTAGO MAJORDNA Labs, Inc.d62673a9-8a67-4580-a8bf-25f85960a5552025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-86ARNICA MONTANA, SILICON DIOXIDE, SODIUM CHLORIDE, LEAD ACETATE ANHYDROUS, SELENICEREUS GRANDIFLORUS STEM, TRIBASIC CALCIUM PHOSPHATE, AND POTASSIUM IODIDEDNA Labs, Inc.54fa62d3-c129-4826-a794-f3dcc6b855bf2025-01-13WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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