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 46 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IODIUM HPBARIUM CARBONATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, FUCUS VESICULOSUS, IODINE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED, THYROIDNatural Creations, Inc.9353d604-e168-4df1-9726-e965c9fc2c782025-12-16WarningsExact identifier
unii: 451W47IQ8X
unii: I76KB35JEV
LYCOPODIUM HPAMANITA MUSCARIA FRUITING BODY, ONION, ARNICA MONTANA, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, PHOSPHORUS, LEADNatural Creations, Inc3f477ed2-1e5e-480e-9cde-121d32c4d0752025-12-16WarningsExact identifier
unii: 27YLU75U4W
unii: 492225Q21H
Mold AntigenALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, BOLETUS SAT, BOTRYTIS CINEREA, CLADOSPORIUM METANIGRUM, FUSARIUM OXYSPORUM, HELMINTHOSPORIUM, MUCOR MUECEDO, PULLULARIA PULLULANS, RHIZOPUS NIGRICANS, USTILAGO MAYDIS, ARSENICUM ALB, CANDIDA ALB, CARBO AN, LACHESIS, LYCOPODIUM, MERC SOLUB, NITRICUM AC, PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, THUJA OCCNatural Creations, Inc9dd6f22e-45b0-4771-80f7-6f530c96350d2025-12-16WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
MENOPAUSE HPATROPA BELLADONNA, BLACK COHOSH, LACHESIS MUTA VENOM, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, CLAVICEPS PURPUREA SCLEROTIUM, SEPIA OFFICINALIS JUICE, USTILAGO MAYDISNatural Creations, Inc.38798520-1fcd-4494-b7b7-058633879abf2025-12-16WarningsExact identifier
unii: I76KB35JEV
NAUSEA VOMITING HPARSENIC TRIOXIDE, ANAMIRTA COCCULUS SEED, IPECA, WOOD CREASOTE, KEROSENE, PULSATILLA VULGARIS, SANGUINARIA CANDENSIS ROOT, TOBACCO LEAFNatural Creations, Inc.5f5b3d53-bfd8-4f74-8ee5-8b8b35f7f97e2025-12-16WarningsExact identifier
unii: I76KB35JEV
HivesECHINACEA ANG, APIS MEL, ARSENICUM ALB, CARBOLICUM AC, LEDUM, RHUS TOX, SULPHUR, URTICA URENSNatural Creations, Incc453ac40-1865-4297-b7d4-c8e637bb5f942025-12-16WarningsExact identifier
unii: 70FD1KFU70
NasalARSENICUM ALBUM, EUPHORBIUM OFFICINARUM, HEPAR SULPHURIS CALCAREUM, HISTAMINUM, IODIUM, LYCOPODIUM, PULSATILLANatural Creations, Inc1a9c0332-e00c-4e86-8077-67003b1205092025-12-16WarningsExact identifier
unii: I76KB35JEV
unii: 1MBW07J51Q
Sleepy Time CPACONITUM, ARSENICUM ALB, CALC CARB, COFFEA CRUDA, MAGNESIUM MET, NUX VOM, PULSATILLA, SEPIA, SULPHURNatural Creations, Inc03cbb408-7e2a-49e8-b83a-b8d932a104592025-12-16WarningsExact identifier
unii: 3SW678MX72
unii: 70FD1KFU70
unii: I76KB35JEV
INJURY HPARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, HYPERICUM PERFORATUM, PHOSPHORUS, RANCID BEEF, SILICON DIOXIDE, DELPHINIUM STAPHISAGRIA SEED, COMFREY ROOTNatural Creations, Inc.10be3e95-da2f-4340-8c12-2e676472a94d2025-12-16WarningsExact identifier
unii: 27YLU75U4W
InjuryCALENDULA OFFICINALIS, SYMPHYTUM OFFICINALE, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA ALBA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, PHOSPHORUS, RHUS TOXICODENDRON, RUTA GRAVEOLENS, STAPHYSAGRIA, PYROGENIUMNatural Creations, Incb4b850fb-6fdd-47b7-8a6e-2e596ec6256c2025-12-16WarningsExact identifier
unii: 27YLU75U4W
PanacodeSYZYGIUM, HYDRASTIS, ADRENALINUM, PANCREATINUM, PITUITARUM POSTERIUM, BOVISTA, INSULIN, LYCOPERSICUM, PHOSPHORICUM AC, PHOSPHORUS, TARENTULA HISPANA, TEREBINTHINA, URANIUM NITRICUMNatural Creations, Incf2144c14-28a2-4dc4-b517-0f81e9c8b7202025-12-16WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: 70FD1KFU70
SINUS HPAMBROSIA ARTEMISIIFOLIA, ARSENIC TRIOXIDE, CALCIUM SULFIDE, POTASSIUM DICHROMATE, POTASSIUM SULFATE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIGNatural Creations, Inc.f017da22-74c2-40f4-adcc-5e84b6ea52912025-12-16WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: I76KB35JEV
unii: 1MBW07J51Q
RespirasodeBRYONIA, DULCAMARA, KALI CARB, SANGUINARIA, BELLADONNA, BROMIUM, CANDIDA ALB, CANDIDA PARAP, CONIUM, LYCOPODIUM, PULSATILLA, SECALE, SILICEA, STICTA, SULPHUR, USTILAGO MAIDISNatural Creations, Incce06327f-7e5e-420a-9b61-0d410f9e10d62025-12-16WarningsExact identifier
unii: 70FD1KFU70
unii: I76KB35JEV
Hydrate 1BERBERISAQUI,BETAVULGARIS,BOLDO,CARDUUSMARIANUS,CHELIDONIUMMAJUS,ELEUTHEROCOCCUS SENTICOSUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,TARAXACUMOFFICINALE,XANTHOXYLUMFRAXINEUM,ULMUSFULVA,GLYCYRRHIZAGLABRA,GETTYSBURGAQUA,WILDBADAQUA,CARLSBADAQUA,ATP,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA,HYDROGENNatural Creations, Inc189bc53c-5d75-48df-a74e-cfff2d08d3a92025-12-16WarningsExact identifier
unii: 2788Z9758H
unii: 451W47IQ8X
Hydrate 2BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUANatural Creations, Inc1122605f-715e-4f12-9d9d-a20442f9cd452025-12-16WarningsExact identifier
unii: 2788Z9758H
unii: 451W47IQ8X
DRx Blemish Clarifying MaskSULFURDr. Dennis Gross Skincare7093a8d4-1910-4b23-9d88-d3398db0916a2025-12-15WarningsExact identifier
unii: 70FD1KFU70
EarAche ReliefAPIS MELLIFERA, ARNICA MONTANA, ATROPA BELLADONNA, TRIBASIC CALCIUM PHOSPHATE, ECHINACEA, UNSPECIFIED, CALCIUM SULFIDE, MERCURIUS SOLUBILISTRP Companye7813a36-4d1f-465e-9b76-1ab6b9f5b96f2025-12-15WarningsExact identifier
unii: 1MBW07J51Q
Fibromyalgia ReliefBRYONIA ALBA ROOT - CAUSTICUM - LOESELIA MEXICANA WHOLE - MAGNESIUM PHOSPHATE - PULSATILLA VULGARIS - TOXICODENDRON PUBESCENS LEAF - VALERIANTRP Companya6ba3058-ec39-715f-e053-2995a90aa32a2025-12-15WarningsExact identifier
unii: I76KB35JEV
Skin RepairROSA CANINA, MATRICARIA RECUTITA, ARCHILLEA MILLEFOLIUMSpry Life LLC7bd56d39-83d0-3d55-e053-2a91aa0a571a2025-12-15WarningsExact identifier
unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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