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 76 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products Coffea CrudCOFFEA CRUDABestmade Natural Products2f970a53-bdfd-c23e-e063-6294a90aa1a52025-03-05WarningsExact identifier
unii: 3SW678MX72
Bestmade Natural Products BM246AESCULUS, AURUM MET, COCCULUS, CHINA OFF, NUX VOMICA, LYCOPODIUM, SULPHURBestmade Natural Products2f99c19d-af9c-5c40-e063-6394a90ab9dd2025-03-05WarningsExact identifier
unii: 70FD1KFU70
Bestmade Natural Products BM247AMM. BROM, CALC CARB, FUCUS VES, KALI BROM, PHYTOLACCA BERY, PULSATILLABestmade Natural Products2f9a2db9-32dc-93e5-e063-6394a90a05772025-03-05WarningsExact identifier
unii: I76KB35JEV
BART PLUSACONITUM NAPELLUS, APIS MELLIFICA, ARBUTUS ANDRACHNE, ARNICA MONTANA, ARSENICUM ALBUM, COCCULUS INDICUS, ECHINACEA (ANGUSTIFOLIA), GLYCYRRHIZA GLABRA, GUNPOWDER, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALMIA LATIFOLIA, LAC CANINUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, STRAMONIUM, TELLURIUM METALLICUM, THYROIDINUM (SUIS), VERATRUM ALBUMDeseret Biologicals, Inc.4de3d6d4-108c-41b9-8aa7-4225ce494d782025-03-04WarningsExact identifier
unii: 2788Z9758H
unii: ZW3Z11D0JV
unii: 1MBW07J51Q
Bestmade Natural Products BM229VERAT ALB, BRYONIA ALB, PULSATILLA, TEREBINTHINA, CALC PHOS, ARGENTUM NITBestmade Natural Products2f807fd9-9f9f-5978-e063-6394a90a67f52025-03-04WarningsExact identifier
unii: I76KB35JEV
Bestmade Natural Products BM230ACID BENZ, CIMICIFUGA, COLCHICUM, LEDUM, PULSATILLA, RUTA GR, CALC PHOSBestmade Natural Products2f80cfae-5f8c-7cbf-e063-6394a90a43fd2025-03-04WarningsExact identifier
unii: I76KB35JEV
Bestmade Natural Products BM232FERR MET, LOBELIA INF., MAG PHOS, PULSATILLA, RATANHIA, SENECIO, VIBURNUM OP.Bestmade Natural Products2f8187e3-150f-871e-e063-6294a90a18ad2025-03-04WarningsExact identifier
unii: I76KB35JEV
Bestmade Natural Products BM236ARG. MET, ARNICA MONT, BRYONIA, CHAMOMILLA, RANUNCULUS BULB, RHUS TOX, RUTA GRAVBestmade Natural Products2f82b461-7059-eacf-e063-6294a90a2ca92025-03-04WarningsExact identifier
unii: G0R4UBI2ZZ
Bestmade Natural Products BM237BELLADONA, BARYTA CARB, HEPAR SULPH, KALI BICH, MERC IOD FLAV, MERC IOD RUB, SILICEABestmade Natural Products2f82f2c4-a549-9e17-e063-6394a90aea812025-03-04WarningsExact identifier
unii: 1MBW07J51Q
Bestmade Natural Products BM240AGRIMONIA, ARSENIC ALBUM, CIMICIFUGA, GRAPHITE, HYDRASTIS CAN, KALI BICH, KREOSOTUM, NITRICUM ACIDUMBestmade Natural Products2f83481b-e95f-c002-e063-6394a90a1d382025-03-04WarningsExact identifier
unii: ZW3Z11D0JV
Bestmade Natural Products BM244CALC CARB, CALC PHOS, CARBO VEG, NAT MUR, PHYSOSTIGMA, RUTA GRAV.Bestmade Natural Products2f853410-e831-90ce-e063-6394a90a26b12025-03-04WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM245AMOORA ROHITAKA, CARDUUS MAR, CEANOTHUS, CHELIDONIUM, COSTUS IGNEUS, LACTUCA VIROSA, HYDRASTISBestmade Natural Products2f856e3d-be7a-fe34-e063-6294a90a77dd2025-03-04WarningsExact identifier
unii: ZW3Z11D0JV
Thera Plus HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEFOURSTAR GROUP USA, INC.87143a7a-7b2d-4b67-afda-2355697e73002025-03-04WarningsExact identifier
unii: PDC6A3C0OX
Sambucus Cold Flu Relief Hot Drink Lemon FlavoredPELARGONIUM SIDOIDES, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, SAMBUCUS NIGRA, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, SEMPERVIRENS, PHOSPHORUSUniversal Synergetics, Inc2ca2064a-2011-48fb-a47a-837ea3fc9bf62025-03-04WarningsExact identifier
unii: 27YLU75U4W
Pulsatilla 30XPULSATILLA VULGARISTrue Botanica, LLC2bae8d35-1724-f1f4-e063-6294a90a374c2025-03-03WarningsExact identifier
unii: I76KB35JEV
Bestmade Natural Products BM214CARBO VEG, FERRUM PHOS, SILICA, KALI CARB, CALC PHOS, NAT MURBestmade Natural Products2f6e08d8-a6f9-c049-e063-6394a90a6df12025-03-03WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM215ANTI CRUD, CAJUPAT, CARBO VEG, LYCOPODIUM, NUX VOMICA, PULSATILLA, ARG NITBestmade Natural Products2f6e7940-e5a8-e805-e063-6394a90a61c52025-03-03WarningsExact identifier
unii: I76KB35JEV
Bestmade Natural Products BM218ACONITE, HEPAR SULPH, SPONGIA, MOSCHUS, SAMBOCUSBestmade Natural Products2f6f3f24-ceff-3194-e063-6394a90a72e42025-03-03WarningsExact identifier
unii: 1MBW07J51Q
Bestmade Natural Products BM223ANTI CRUD, ARG NIT, CALC PHOS, IRIS GERM, PULSATILLA, SULPHUR, THUJABestmade Natural Products2f6ff0ea-acb9-3d48-e063-6294a90a4c8b2025-03-03WarningsExact identifier
unii: 70FD1KFU70
unii: I76KB35JEV
QUALITY CHOICE Ear Relief DropsCHAMOMILE, MERCURIUS SOLUBILIS, SULFURChain Drug Marketing Association, Incd7626699-4ad3-4f0f-a96d-8b972b1b79132025-02-28WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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