FDA.reportPublic FDA data

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 115 of 163 · 3,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhosphorusPHOSPHORUSSEVENE USA3c567123-a9b1-4dd4-bd83-142665aced7b2024-01-30WarningsExact identifier
unii: 27YLU75U4W
PulsatillaPULSATILLA VULGARISSEVENE USA50113409-0228-4403-aded-92e72e220aa72024-01-30WarningsExact identifier
unii: I76KB35JEV
SULPHURSULFURSEVENE USAa727addd-575c-4c46-ad1d-cd9f8d11152d2024-01-30WarningsExact identifier
unii: 70FD1KFU70
Calm Eczema Therapy WashSULPHUR 12XKamedis38a3495e-6872-4cb8-bab7-1c93e1470e2c2024-01-30WarningsExact identifier
unii: 70FD1KFU70
Hepar Sulphuris Calcareum 30cCALCIUM SULFIDESEVENE USAfdf6a2c6-28d6-43ca-9b1f-05169de6bbd72024-01-29WarningsExact identifier
unii: 1MBW07J51Q
HYDRASTIS CANADENSISGOLDENSEALSEVENE USA59a9525b-8d3b-4eb1-9ae9-6213161c3dfe2024-01-29WarningsExact identifier
unii: ZW3Z11D0JV
Systemic DrainageALFALFA, AVENA SATIVA, CITRUS LIMONUM, GLYCYRRHIZA GLABRA, UVA-URSI, TARAXACUM OFFICINALE, GALIUM APARINE, SCHISANDRA CHINENSIS, SOLIDAGO VIRGAUREA, TABACUM, BERBERIS VULGARIS, CHELIDONIUM MAJUS, HEPAR SUIS, INTESTINE (SUIS), KIDNEY (SUIS), LUNG (SUIS), LYMPH NODE (SUIS), MAGNESIUM GLUCONATE, POTASSIUM GLUCONATE, ZINCUM GLUCONICUM, NUX VOMICA, SARCOLACTICUM ACIDUM, LACTICUM ACIDUM, TYLOPHORA ASTHMATICADeseret Biologicals, Inc.5e54d366-4025-4131-af8c-10ac8c500af52024-01-29WarningsExact identifier
unii: 2788Z9758H
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta14ca7d9-de30-a303-e053-2a95a90a53042024-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirste5247ed5-6170-c13f-e053-2a95a90a41012024-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
No More ProductsGLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc102e7dbb-06dc-f4d1-e063-6394a90aa3eb2024-01-26WarningsExact identifier
unii: PDC6A3C0OX
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc.0fe10710-ac59-4fc5-e063-6294a90a48fc2024-01-26WarningsExact identifier
unii: PDC6A3C0OX
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea2024-01-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Throat CareECHINACEA, ACONITUM NAP., APIS MEL., ARUM DRAC., BELLADONNA, BRYONIA, CAJUPUTUM, FERRUM PHOS., GLYCYRRHIZA, KALI BIC., LACHESIS, MENTA PIP., MERC. VIV., NAJA, NAT. CARB., NAT SULPHURICUM, NITRICUM AC., NUX VOM., PHOS., PHYTOLACCA, PULSATILLA, SPONGIA, STANNUM MET., STICTA, THUJA OCC., ULMUS FULV., VERBASCUMNewton Laboratories, Inc.0fb69003-c66c-97ad-e063-6394a90a4c9b2024-01-24WarningsExact identifier
unii: 27YLU75U4W
unii: 2788Z9758H
unii: I76KB35JEV
Chamomilla 30cMATRICARIA RECUTITASEVENE USAe26bedb2-cd71-4550-b1b3-4f967363d45a2024-01-24WarningsExact identifier
unii: G0R4UBI2ZZ
Coffea Cruda 30cARABICA COFFEE BEANSEVENE USA9d35b8c6-4e1e-4bfb-8424-6a00208be6002024-01-24WarningsExact identifier
unii: 3SW678MX72
SULFACETAMIDE SODIUM, SULFURSULFACETAMIDE SODIUM, SULFURCintex Services, LLC0d1efaac-d62b-41b9-e063-6394a90a94ad2024-01-23Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SULFACETAMIDE SODIUM, SULFURSULFACETAMIDE SODIUM, SULFURCintex Services, LLC0d1f8666-95ff-7844-e063-6394a90af4122024-01-23Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SULFACETAMIDE SODIUM, SULFURSULFACETAMIDE SODIUM, SULFURCintex Services, LLC0e128306-1357-daad-e063-6294a90a760a2024-01-23Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
CIRCULATION HPARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, LACHESIS MUTUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREA,Energique, Inc.464d208b-3893-4ec6-9868-12ef6807b98d2024-01-23WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
SULFACETAMIDE SODIUM, SULFURSULFACETAMIDE SODIUM, SULFURCintex Services, LLC0fa2c52d-5d4a-4b83-e063-6394a90a54062024-01-23Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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