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 25 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM SULFACETAMIDE, SULFURSODIUM SULFACETAMIDE 8% SULFUR 4%Aspen Medical LLC4ba94e96-b107-77fe-e063-6394a90aa9802026-02-21Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Allergy KidsURTICA DIOICA LEAF, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND ALTHAEA OFFICINALIS ROOTForces of Nature4886109c-dd7d-40c0-911f-5f12343d8e632026-02-20WarningsExact identifier
unii: 451W47IQ8X
Allergy Maximum StrengthURTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature122ca23e-43f1-4e5c-afc2-1418b17176792026-02-20WarningsExact identifier
unii: 451W47IQ8X
Back Pain Pain ManagementARNICA MONTANA, HORSE CHESTNUT, HYPERICUM PERFORATUM, RUTA GRAVEOLENS WHOLE, AND SODIUM CHLORIDEForces of Naturebf089347-f334-4d6d-ab58-cf7f0b16810f2026-02-20WarningsExact identifier
unii: 451W47IQ8X
Kids Cough and Mucus Nighttime Grape FlavorRUMEX CRISPUS ROOT, ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA WHOLE, PULSATILLA VULGARIS, CALCIUM SULFIDE, IPECAC, GOLDENSEAL, PHOSPHORUS, FERROSOFERRIC PHOSPHATEHyland's Consumer Health Inc.d83e7877-f599-b364-e053-2995a90ab35f2026-02-19WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: G0R4UBI2ZZ
unii: I76KB35JEV
unii: 1MBW07J51Q
Female StimulantACONITICUM ACIDUM, CIS-, APIS VENENUM PURUM, AQUILEGIA VULGARIS, BOVISTA, CYPRIPEDIUM PUBESCENS, ESTRADIOL, FAECALIS (ALKALIGENES), FOLLICULINUM, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEART (SUIS), HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, KREOSOTUM, LACHESIS MUTUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, MERCURIUS SOLUBILIS, MUTABILE BACILLUS (BACH), OOPHORINUM (SUIS), PETROSELINUM SATIVUM, PINEAL GLAND (SUIS), PLACENTA TOTALIS SUIS, PROGESTERONE, SEPIA, TESTOSTERONE, UTERUS (SUIS)Deseret Biologicals, Inc.0d4b8cbf-8f57-43ca-a904-c69d9056c8652026-02-19WarningsExact identifier
unii: ZW3Z11D0JV
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: 70FD1KFU70
CeleragesicACONITUM NAPELLUS, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA (ALBA), CALENDULA OFFICINALIS, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), ECHINACEA PURPUREA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MILLEFOLIUM, NADIDUM, PANTOTHENIC ACID, RHUS TOX, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALEDeseret Biologicals, Inc.18e573b8-dd8d-432a-90c3-84b8929a40392026-02-18WarningsExact identifier
unii: G0R4UBI2ZZ
unii: 1MBW07J51Q
AllergyCalmONION, AMBROSIA ARTEMISIIFOLIA, EUPHRASIA STRICTA, HISTAMINE DIHYDROCHLORIDE, SCHOENOCAULON OFFICINALE SEED, SOLIDAGO VIRGAUREA FLOWERING TOPBoirond9a509d9-15c8-20bb-e053-2a95a90a3edd2026-02-16WarningsExact identifier
unii: 492225Q21H
VoiceCalmARNICA MONTANA WHOLE, ARISAEMA TRIPHYLLUM ROOT, FERROSOFERRIC PHOSPHATE, CALCIUM SULFIDE, TOXICODENDRON PUBESCENS LEAF, SPONGIA OFFICINALIS SKELETON, ROASTEDBoiron4af6bc5b-7924-cb9f-e063-6394a90a78642026-02-16WarningsExact identifier
unii: 1MBW07J51Q
ColdCalmONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLEBoiron4ae2f15e-45f3-e2e4-e063-6294a90a92bc2026-02-15WarningsExact identifier
unii: 492225Q21H
unii: I76KB35JEV
ThroatCalmARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, ATROPA BELLADONNA, BROMINE, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLEBoiron4ae45fc7-c0f4-3770-e063-6394a90ac80e2026-02-15WarningsExact identifier
unii: I76KB35JEV
EUGENIA JAMBOSAARNICA MONTANA, BAPTISIA, ECHINACEA, EUGENIA JAMBOSA, HEPAR SHULPHBM Private Limited3b3c63cf-9a75-5a59-e063-6294a90a62d12026-02-15WarningsExact identifier
unii: 1MBW07J51Q
RHODODIUMACTEA RACEMOSA, APIS MELL, CALC CARB, GRAPHITES, IODIUM, NATRUM MUR, PULSATILLA, RHODODENDRONBM Private Limited3b3bcba2-6f9e-cd94-e063-6394a90a77012026-02-15WarningsExact identifier
unii: 451W47IQ8X
BM EczemaCALENDULA, ECHINACEA, GRAPHITE, SULFURBM Private Limited388ceb70-1de2-df89-e063-6294a90a38962026-02-12WarningsExact identifier
unii: 70FD1KFU70
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
Sodium Sulfacetamide and SulfurSULFACETAMIDE SODIUM, SULFURMethod Pharmaceuticals, LLCd35a7764-f3c6-fd1b-e053-2a95a90a80362026-02-12WarningsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 9% and Sulfur 4% CleanserSULFACETAMIDE SODIUM, SULFURMethod Pharmaceuticalsd770b9e2-dbbe-c246-e053-2995a90a398d2026-02-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 9% and Sulfur 4.5% CleanserSULFACETAMIDE SODIUM, SULFURMethod Pharmaceuticalsd770860b-ecbd-ba22-e053-2a95a90af6912026-02-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 8% and Sulfur 4% CleanserSULFACETAMIDE SODIUM, SULFURMethod Pharmaceuticalsd8dcbf63-58f0-0a25-e053-2a95a90a76332026-02-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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