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 111 of 163 · 3,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neuro IITARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, ACETYLCHOLINE CHLORIDE, HISTAMINUM HYDROCHLORICUM, ADRENALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), NOREPINEPHRINE (BITARTRATE), TYRAMINEDeseret Biologicals, Inc.0ebfcaa7-4867-4d4e-a2f0-631e8eb479912024-04-01WarningsExact identifier
unii: ZW3Z11D0JV
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
Oral HealthANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, BORAX, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CHAMOMILLA, CINCHONA OFFICINALIS, DISCUS INTERVERTEBRALIS SUIS, STREPTOCOCCUS DYSGALACTIAE DNA, STREPTOCOCCUS MUTANS DNA, STREPTOCOCCUS PNEUMONIAE DNA, ECHINACEA PURPUREA, IGNATIA AMARA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NUX MOSCHATA, ORAL MUCOSA (SUIS), OXYGENIUM, SAMBUCUS NIGRA, SEPIA, STAPHYLOCOCCUS AUREUS,Deseret Biologicals, Inc.6f66ff40-6e0e-4a35-963c-965c65df76eb2024-04-01WarningsExact identifier
unii: G0R4UBI2ZZ
Heart/FatigueKALI CARBONICUM, ARNICA MONTANA, CACTUS GRANDIFLORUS, CASTOREUM, RANUNCULUS BULBOSUS, GELSEMIUM SEMPERVIRENS, GLONOINUM, HEART (SUIS), SPIGELIA ANTHELMIA, ABROTANUM, SULPHURDeseret Biologicals, Inc.560c2269-2cc8-489e-8487-9661ff7017d82024-03-27WarningsExact identifier
unii: 70FD1KFU70
CVS Health Sterile Saline MistSODIUM CHLORIDECVS Pharmacy14931004-1efb-e331-e063-6294a90ad66e2024-03-26WarningsExact identifier
unii: 451W47IQ8X
Aqua marinaSODIUM CHLORIDEBoiron14945760-30b5-27d3-e063-6394a90a8a322024-03-26Exact identifier
unii: 451W47IQ8X
Headache HPBELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUMEnergique, Inc.5dca8670-c931-47e3-af89-b5f09f5f4e022024-03-26WarningsExact identifier
unii: 451W47IQ8X
PNEUMOPLEXPLANTAGO MAJOR, ARSENICUM ALBUM, LUNG (BOVINE), SYMPHYTUM OFFICINALE, SILICEA, PHELLANDRIUM AQUATICUM, PHOSPHORUS, SULPHURBioActive Nutritional, Inc.d839aea1-7725-40c1-b000-228843f75b932024-03-26WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
FlutoneBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ARSENICUM ALBUM, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, RHUS TOX.Energique, Inc.d5359dc3-e0b9-421b-9ee6-7e38e1002f002024-03-26WarningsExact identifier
unii: ZW3Z11D0JV
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEB. Braun Medical Inc.59ccc717-c374-41c0-be58-9647df8811602024-03-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.95406534-526e-4bca-b73d-1030623549a32024-03-26WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: 70FD1KFU70
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
unii: 2788Z9758H
V-Fem CareAGARICUS MUSC., ARSENICUM ALB., AUR. MET., BERBER. AQUI., CALADIUM SEGUINUM, CANDIDA ALBICANS, CANTHARIS, CONIUM, GRAPHITES, HELONIAS DIOICA, HYDRASTIS, KALI CARB., KREOSOTUM, LYCOPODIUM, MERC. VIV., MUREX PURPUREA, NAT. MUR., NITRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SEPIA, SULPHUR, TARENTULA HISPANA, THUJA OCC., ZINC. MET., APIS MEL., HAMAMELISNewton Laboratories, Inc.14800c19-e5c6-924b-e063-6394a90a15e52024-03-25WarningsExact identifier
unii: 451W47IQ8X
unii: ZW3Z11D0JV
unii: 70FD1KFU70
unii: I76KB35JEV
ControlANACARDIUM ORIENTALE, AQUA MARINA, ARGENTUM NITRICUM, ASARUM CANADENSE, BLATTA ORIENTALIS, BUFO RANA, CEREBRUM SUIS, CLEMATIS ERECTA, CUPRUM ACETICUM, HYPOTHALAMUS SUIS, IGNATIA AMARA, KALI PHOSPHORICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, PLACENTA TOTALIS SUIS, RHUS TOX, THUJA OCCIDENTALIS, THYMOLUM, VALERIANA OFFICINALISDeseret Biologicals, Inc.9daec04d-44fb-4d0f-8e21-1109f515eb5d2024-03-25WarningsExact identifier
unii: 451W47IQ8X
GriefCIMICIFUGA RACEMOSA, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, SEPIA, CEREBRUM SUIS, IGNATIA AMARA, NATRUM MURIATICUM, AMBRA GRISEA, DNA, AURUM METALLICUM, COCCULUS INDICUS, DIGITALIS PURPUREA, HELLEBORUS NIGER, LYCOPODIUM CLAVATUM, STAPHYSAGRIADeseret Biologicals, Inc.e7ff1297-512e-4e95-a918-1c57fa3a50dd2024-03-25WarningsExact identifier
unii: 451W47IQ8X
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
Shing-VCHAMOMILLA, ECHINACEA, APIS MELLIFICA, ARSENICUM ALBUM, ASTERIAS RUBENS, CANTHARIS, CISTUS CANADENSIS, CROTON TIGLIUM, DOLICHOS PRURIENS, DULCAMARA, GRAPHITES, GRINDELIA, HYPERICUM PERFORATUM, IRIS VERSICOLO, LYCOPODIUM CLAVATUM, MEZEREUM, RANUNCULUS BULBOSUS, RHUS TOXICODENDRON, STAPHYSAGRIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUMNewton Laboratories, Inc.141cc010-9b93-b82a-e063-6394a90aef442024-03-21WarningsExact identifier
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
Dr Dale Wellness NU Fem 1 2 3 All In One Topical HomeopathicDHEA,ADRENAL CORTISOL,GLANDULA SUPRARENALIS SUIS,HUMAN GROWTH HORMONE,IGF-I,IGF-II ,HYPOTHALAMUS,PITUITARY,PLACENTA,LIVER,THYMUS,RNA,DNA,ESTROGENIUM,ESTRADIOLINUM,SANGUINARA CANDENSIS,OOPHORINUM,PROGESTERONIUM,PITITUARINUM,PINEAL,FOLLICULINUM,OVARINUM,CHELADONIUM,SULPHUR,SEPIA,LAGENINE ,TESTOSTERONE,CIMICIFUGA BLACK COHOSH,LILIUM TIGRINUM,GRAPHITES,KALI PHOSPHORICUM ,CAUSTICUM,CALCAREA CARBONICA,PHYTOLACCA,SCROPHULARIA NODOSADMD Clinical Naturopathy7679472c-bc6a-40c1-8e66-adc0b6ca18b42024-03-21WarningsExact identifier
unii: 70FD1KFU70
Shing-VCHAMOMILLA, ECHINACEA, APIS MELLIFICA, ARSENICUM ALBUM, ASTERIAS RUBENS, CANTHARIS, CISTUS CANADENSIS, CROTON TIGLIUM, DOLICHOS PRURIENS, DULCAMARA, GRAPHITES, GRINDELIA, HYPERICUM PERFORATUM, IRIS VERSICOLO, LYCOPODIUM CLAVATUM, MEZEREUM, RANUNCULUS BULBOSUS, RHUS TOXICODENDRON, STAPHYSAGRIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUMNewton Laboratories, Inc.141c2079-0766-8ca0-e063-6394a90a4bd22024-03-20WarningsExact identifier
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
Snore-SootheECHINACEA, BRYONIA, CAMPHORA, CISTUS CANADENSIS, DROSERA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IGNATIA AMARA, IODIUM, KALI BICHROMICUM, KALI IODATUM, PHOSPHORUS, PULSATILLA, SABADILLA, SILICEA, STICTA PULMONARIA, SULPHUR, TEUCRIUM MARUM, VERBASCUM THAPSUS, ARSENICUM ALBUM, BELLADONNA, HISTAMINUM HYDROCHLORICUM, LAC CANINUM, NUX VOMICANewton Laboratories, Inc.140a0bcf-82b3-c430-e063-6294a90ad38f2024-03-19WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: 70FD1KFU70
unii: I76KB35JEV
unii: 1MBW07J51Q

Reported adverse events (FAERS/openFDA)#

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