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 85 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergena FragranceALLERGENA FRAGRANCEMeditrend, Inc. DBA Progena Professional Formulationse3ab2f9f-f2a3-434a-b3b4-115ecd3d99b72025-01-28WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: 70FD1KFU70
Allergena Texas Cedar FeverECHINACEA,BAPTISIA TINCTORIA, HYDRASTIS CANADENSIS, MYRRHA, PHYTOLACCA DECANDRA, TRIGONELLA FOENUM-GRAECUM, TEXAS TREE, TEXAS WEED, TEXAS GRASSMeditrend, Inc. DBA Progena Professional Formulations0277188f-47d5-4e8d-b697-a0bd3998c68e2025-01-28WarningsExact identifier
unii: ZW3Z11D0JV
Allergena Pet DanderHOMEOPATHIC SUBLINGUAL IMMUNOTHERAPYMeditrend, Inc. DBA Progena Professional Formulations720a7575-57b8-498e-8b67-e5374836e1232025-01-28WarningsExact identifier
unii: ZW3Z11D0JV
OrgandrainexALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, CYNARA SCOLYMUS, PETROSELINUM SATIVUM, TRIFOLIUM PRATENSE, METHYLCOBALAMIN, ALOE, ALPHA-LIPOICUM ACIDUM, PALLADIUM METALLICUMEnergique, Inc.657065f2-b5c6-4036-a864-14169ddcd3bc2025-01-28WarningsExact identifier
unii: 492225Q21H
Fever-InfectionCHAMOMILLA, ECHINACEA HYDRASTIS CANADENSIS, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAMPHORA, CINA, CINCHONA OFFICINALIS, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, IGNATIA AMARA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, SALIX NIGRA, VERATRUM VIRIDE, INFLUENZINUMNewton Laboratories, Inc.9d762268-8c30-8a86-e053-2a95a90a419c2025-01-27WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: ZW3Z11D0JV
unii: G0R4UBI2ZZ
unii: I76KB35JEV
unii: 1MBW07J51Q
DiarrheaAESCULUS HIPPOCASTANUM, JUGLANS REGIA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, ELATERIUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, RHEUM, SULPHUR, TABACUM, VACCINIUM MYRTILLUSNewton Laboratories, Inc.9d7322da-c2fb-0fc3-e053-2a95a90ac70b2025-01-27WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
SnifflesECHINACEA, ACONITUM NAPELLUS, ARALIA QUINQUEFOLIA, ARSENICUM ALBUM, BRYONIA, EUPHRASIA OFFICINALIS, GAULTHERIA PROCUMBENS, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALVIA OFFICINALIS, STICTA PULMONARIA, THUJA OCCIDENTALIS, VERBASCUM THAPSUS, SINUSITISINUM, INFLUENZINUMNewton Laboratories, Inc.9db1327c-6746-76cb-e053-2995a90a6e272025-01-27WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: I76KB35JEV
Histastat PollenBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDESEnergique, Inc.5a94659f-b62a-41d8-81c0-87a68c02606d2025-01-27WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: 492225Q21H
unii: 70FD1KFU70
Jointstat BBCHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ARSENICUM ALBUM, BRYONIA (ALBA), COLCHICUM AUTUMNALE, KALMIA LATIFOLIA, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, PHOSPHORUS, RHUS TOXEnergique, Inc.97f4c278-e0fb-45f4-bc5d-1d368978dd662025-01-27WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
Hamamelis AesculusHAMAMELIS AESCULUSUriel Pharmacy Inc.1f8c94c5-9010-436b-b868-1c759fc4f3ef2025-01-25WarningsExact identifier
unii: I76KB35JEV
Endopan HPACETICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, BRYONIA (ALBA), CHROMIUM, COLCHICUM AUTUMNALE, LACTICUM ACIDUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, SYZYGIUM JAMBOLANUM, THUJA OCCIDENTALIS, URANIUM NITRICUMEnergique, Inc.2bc69a24-c24c-4d12-92bb-7c073edf90dc2025-01-24WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
Bestmade Natural Products BM56EUPHORBIUM, HYDRASTIS, KALI BICH, KALI IOD, MERCURIUS SOL, OSCILLOCOCCINUM, PRUNUS VIRGBestmade Natural Products2c75631c-aa2c-46ba-e063-6294a90aa0ed2025-01-24WarningsExact identifier
unii: ZW3Z11D0JV
Bestmade Natural Products BM58BERB VULG, CARDUUS MAR, CHELIDONIUM, CHIONANTHUS, DIOSCOREA, FEL TAURI, HYDRASTISBestmade Natural Products2c75fa0c-09d5-dd1b-e063-6294a90a0f292025-01-24WarningsExact identifier
unii: ZW3Z11D0JV
Bestmade Natural Products BM59CALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCCBestmade Natural Products2c763956-a1de-c8df-e063-6294a90a5c812025-01-24WarningsExact identifier
unii: 451W47IQ8X
unii: 70FD1KFU70
unii: 1MBW07J51Q
Equate Sterile Saline MistSODIUM CHLORIDEWALMART INC.275ada29-8904-fe1e-e063-6394a90abe592025-01-24WarningsExact identifier
unii: 451W47IQ8X
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: ZW3Z11D0JV
Glucose and Sodium ChlorideDEXTROSE ANHYDROUS AND SODIUM CHLORIDEBaxter Healthcare Corporation1ba918d0-13d0-48bc-8742-658fc0eb47b62025-01-24Exact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation93aeac13-41de-4452-9f38-d6b4f38ada302025-01-24Exact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM24ANACARDIUMD7, ASHWAGANDHAD2, BELLADONNAD7, GELSEMIUMD5, KALI PHOSD3, PHOSPHORUSD12, SEPIAD7Bestmade Natural Productsededa15e-1aa7-9d49-e053-2a95a90a09642025-01-23WarningsExact identifier
unii: 27YLU75U4W
Bestmade Natural ProductsAVENA SATD1, COFFEA CRUDAD5, HUMULUS LUPD5, IGNATIAD5, NUX VOMICAD4, PASSIFLORAD1, VALERIANAD1Bestmade Natural Productsedee55dd-4897-e78a-e053-2995a90adc462025-01-23WarningsExact identifier
unii: 3SW678MX72

Reported adverse events (FAERS/openFDA)#

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