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 86 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BM31ARNICA MONTD4, CALC FLOURD3, CALENDULAD3, ECHINACEAD10, HAMAMELISD2, HEPAR SULPHD5, PULSATILLAD7Bestmade Natural Productsef0843e3-a126-0c85-e053-2995a90a977d2025-01-23WarningsExact identifier
unii: 1MBW07J51Q
Bestmade Natural Products BM33ACID FOLICD10, ACID PHOSD4, ARSENIC ALBD4, AVENA SATD3, BETA VULGD5, CHINA OFFD12, FERR METD5, NATRUM MURD5Bestmade Natural Productsef2beaff-5c94-de60-e053-2995a90ad7962025-01-23WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM34ACONITED6, BELLADONNAD5, BRYONIAD7, FERR PHOSD7, IPECACD7, LACHESISD16, PHOSPHORUSD14Bestmade Natural Productsef2cb539-05f5-8a71-e053-2a95a90a3ac52025-01-23WarningsExact identifier
unii: 27YLU75U4W
SODIUM SULFACETAMIDE AND SULFURSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.2c631307-b8a3-2978-e063-6394a90a79c32025-01-23Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Bestmade Natural Products BM51BERB VULG, CARDUUS MAR, CHIONANTHUS, CHELIDONIUM, HYDRASTIS, KALMEGH, MYRICA, PODOPHYLUMBestmade Natural Products2c64dbda-e13a-c99d-e063-6394a90af5812025-01-23WarningsExact identifier
unii: ZW3Z11D0JV
Bestmade Natural Products BM53APIS MELLIFICA, APIUM VIRUS, ARSENIC ALB, BRYONIA ALB, SULPHURBestmade Natural Products2c656774-f04b-4490-e063-6294a90a68562025-01-23WarningsExact identifier
unii: 70FD1KFU70
Anti Acne Natural Volcanic SulfurSULFURPT. GALENIUM PHARMASIA LABORATORIESa19ac01b-950a-4ddb-9711-17f15bdb40132025-01-23WarningsExact identifier
unii: 70FD1KFU70
Anti Acne Natural Volcanic SulfurSULFURPT. GALENIUM PHARMASIA LABORATORIES4f230abd-5c07-4121-81da-a9fa2d20a2ca2025-01-23WarningsExact identifier
unii: 70FD1KFU70
Anticoagulant Citrate Dextrose A ACD-AANTICOAGULANT CITRATE DEXTROSE A ACD-AArteriocyte Medical Systems, Inc.b850deac-161f-4bb0-ac7f-bceac2a230c02025-01-23Exact identifier
unii: 2968PHW8QP
Bestmade Natural Products Nat Mur (Lactose-Free)NATRUM MURIATICUMBestmade Natural Products2c4b8827-e724-858a-e063-6394a90a3b4e2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBestmade Natural Productse9fb280b-2f79-f268-e053-2995a90a732c2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM1APIS MELLD4, BARYTA CARBD8, BELLADONNAD3, CALC IODD6, HEPAR SULPHD12, KALI BICHD4, LACHESISD12, MERCURIUSD8, PHYTOLACCAD4, SPONGIAD3Bestmade Natural Productseb63c669-8ac7-a40b-e053-2a95a90ad74c2025-01-22WarningsExact identifier
unii: 1MBW07J51Q
Bestmade Natural Products Bio2KALI PHOS, MAG PHOS, NAT MUR, NAT SULFBestmade Natural Productse9fc4f2f-a699-163f-e053-2995a90ab1fe2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM2ACID NITD6, AESCULUS HIPD4, HAMAMELISD3, HYDRASTISD3, NUX VOMICAD4, PAEONIAD3, SULPHURD4Bestmade Natural Productseb650a35-8833-702a-e053-2995a90afe0f2025-01-22WarningsExact identifier
unii: ZW3Z11D0JV
unii: 70FD1KFU70
Bestmade Natural Products Bio4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Productsea224687-106e-3821-e053-2995a90aa69c2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio5FERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Productsea22e5e7-491a-91ac-e053-2a95a90a44142025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio6FERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Productsea233792-038f-39e7-e053-2995a90a20ad2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM3BERB. VULGD3, CARDUUS MD2, CHELIDONIUMD2, CHOLESTRINUMD3, HYDRASTISD3, PTELEAD3Bestmade Natural Productseb65fa7a-1267-dc4f-e053-2995a90ae64f2025-01-22WarningsExact identifier
unii: ZW3Z11D0JV
Bestmade Natural Products BM4ALOE SOCOD8, COLOCYNTHISD6, IPECACD7, MYRICA CERD7, PODOPHYLLUMD8, SULPHURD5, VERATRUM ALBD6Bestmade Natural Productsebdbb884-c060-7065-e053-2995a90a4cd52025-01-22WarningsExact identifier
unii: 70FD1KFU70
Bestmade Natural Products BM6AGRIMONIAD6, ALUMINAD12, HYDRASTISD4, KALI BICHD6, PULSATILLAD5, SEPIAD4Bestmade Natural Productsec034f53-5577-5985-e053-2995a90a67292025-01-22WarningsExact identifier
unii: ZW3Z11D0JV
unii: I76KB35JEV

Reported adverse events (FAERS/openFDA)#

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