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 59 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cedar X FormulaOLIBANUM, THUJA OCCIDENTALIS, GELSEMIUM SEMPERVIRENS, ALLIUM CEPA, ANTIMONIUM TARTARICUM, HEPAR SULPHURIS CALCAREUM, JUNIPERUS COMMUNIS.Integrative Healing Institute, LLC8ab87e13-99ad-4b25-a0c3-e46a868cc6842025-10-17WarningsExact identifier
unii: 492225Q21H
unii: 1MBW07J51Q
Seasonal Allergy FormulaHYDRASTIS CANADENSIS, KALI MURIATICUM, GELSEMIUM SEMPERVIRENS, KALI BICHROMICUM, SABADILLA, HISTAMINUM, HOUSE DUST, GRASS MIX, TREES MIX, WEEDS MIXIntegrative Healing Institute, LLC1d4deee9-5452-421b-a107-ab150d1f62142025-10-17WarningsExact identifier
unii: ZW3Z11D0JV
GlycerinGLYCERINChain Drug Consortium LLC4694f05b-d927-4e15-9630-a0a1cddb3cbb2025-10-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacye6a8914f-cfd9-4c72-abaa-22189bf0faef2025-10-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINChain Drug Marketing Association Inc.3386fada-6b7f-46fd-e063-6294a90abffc2025-10-16WarningsExact identifier
unii: PDC6A3C0OX
SEACALL NAIL REVIVE SERUMNAIL REVIVE SERUMGuangdong Quadrant Ecological Technology Co., Ltd.1f4d0c9a-361e-72e5-e063-6394a90a7cda2025-10-15WarningsExact identifier
unii: 70FD1KFU70
Homeopathic Tea Tree Oil LiceEUCALYPTUS GLOBULUS, NATRUM MURIATICUMDOLGENCORP, LLC0a0c2db2-7eeb-909c-e063-6394a90a7a902025-10-15WarningsExact identifier
unii: 451W47IQ8X
PlexionSULFACETAMIDE SODIUM, SULFURCintex Services, LLC41365fd6-0865-fa55-e063-6294a90a83532025-10-15Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE, SULFURSODIUM SULFACETAMIDE, SULFURCintex Services, LLC4137736e-7c9e-94e0-e063-6294a90ac97c2025-10-15Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE, SULFURSODIUM SULFACETAMIDE, SULFURCintex Services, LLC413746d8-5469-3f62-e063-6294a90af82c2025-10-15Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 9.8% and Sulfur 4.8% CleanserSULFACETAMIDE SODIUM, SULFURCintex Services, LLC4137a6a5-35f4-ad2a-e063-6394a90aac192025-10-15Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide and Sulfer EmulsionSODIUM SULFACETAMIDE AND SULFERTrifluent Pharma40601d03-aea0-b0a6-e063-6394a90a16982025-10-15Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
FinaftaBENZOCAINE, GLYCERINEfficient Laboratories Inc.03368603-3e11-c2fa-e063-6294a90a04ea2025-10-14WarningsExact identifier
unii: PDC6A3C0OX
Stage Fight Acne MaskSULFUR, RESORCINOLCosmetic Enterprises Ltd209e321e-ed20-9c67-e063-6394a90a54102025-10-14WarningsExact identifier
unii: 70FD1KFU70
Saline AmpoulesSODIUM CHLORIDE 0.9%Trifecta Pharmaceuticals USA, LLC.ee18ef7c-bb5d-30ec-e053-2a95a90a964e2025-10-13WarningsExact identifier
unii: 451W47IQ8X
Hamamelis AesculusHAMAMELIS AESCULUSUriel Pharmacy Inc217f677a-a5b6-4df3-97ec-0eafbc9f29ce2025-10-10WarningsExact identifier
unii: I76KB35JEV
GlycerinGLYCERINH E B3d0566a1-57a5-6a31-e054-00144ff88e882025-10-09WarningsExact identifier
unii: PDC6A3C0OX
Naturasil Mite Be GoneSULFURNature's Innovation, Inca482f578-28df-48b0-a6ae-37350d2588142025-10-09WarningsExact identifier
unii: 70FD1KFU70
Kidney LiquescenceJUNIPERUS COMMUNIS, UVA-URSI, EQUISETUM HYEMALE, TARAXACUM OFFICINALE, EUPATORIUM PURPUREUM, KIDNEY (BOVINE), NITRICUM ACIDUM, CANTHARIS, HEPAR SULPHURIS CALCAREUMNutritional Specialties, Inc.34cc5ee6-ef07-49fc-9ba3-fae27d4a75202025-10-08WarningsExact identifier
unii: 1MBW07J51Q
EQUATE SALINE PACKETSNASAL CLEANING SALTWALMART INC9e905ecb-d4d5-514a-e053-2a95a90adfbb2025-10-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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