NDC 54973-3243-01 - 4 KIDS COLD N COUGH GRAPE FLAVOR

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
54973-3243
Requested NDC
54973-3243-01
Package NDCs from labels
54973-3243-1, 54973-3243-2, 54973-3243-3, 54973-3243-4, 54973-3243-5, 54973-3243-01
Manufacturer
Hyland's Inc.
Effective date
2025-12-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hyland's Kids Cold & Cough Daytime Natural Grape FlavorHyland's Inc.2025-12-19HUMAN OTC DRUG LABEL
Hyland's Kids Cold 'n Cough Day & Night Combo Pack Grape FlavorHyland's Inc.2025-12-19HUMAN OTC DRUG LABEL
4 KIDS COLD N COUGH GRAPE FLAVOR - Hyland's Inc. | Applied Laboratories, IncHyland's Inc. | Applied Laboratories, Inc2025-02-20HUMAN OTC DRUG LABEL
4 Kids Cold n Cough Day and Night Value PackHyland's | Standard Homeopathic Company | Applied Laboratories, Inc.2019-11-21HUMAN OTC DRUG LABEL
4 Kids Cold n Cough Day and Night Combo PackHyland's | Standard Homeopathic Company | Applied Laboratories, Inc.2016-06-28HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3243-14 KIDS COLD N COUGH GRAPE FLAVOR118 mL in 1 BOTTLE, PLASTICLIQUID11817
54973-3243-14 KIDS COLD N COUGH GRAPE FLAVOR1 in 1 CARTONLIQUID117
54973-3243-24 KIDS COLD N COUGH GRAPE FLAVOR236 mL in 1 BOTTLE, PLASTICLIQUID23617
54973-3243-24 KIDS COLD N COUGH GRAPE FLAVOR1 in 1 CARTONLIQUID117
54973-3243-34 KIDS COLD N COUGH GRAPE FLAVOR5 mL in 1 POUCHLIQUID517
54973-3243-44 KIDS COLD N COUGH GRAPE FLAVOR1 in 1 CARTONLIQUID117
54973-3243-44 KIDS COLD N COUGH GRAPE FLAVOR148 mL in 1 BOTTLE, PLASTICLIQUID14817
54973-3243-54 KIDS COLD N COUGH GRAPE FLAVOR5 mL in 1 POUCHLIQUID517
54973-3243-14 Kids Cold and Cough Day and Night Grape Flavor1 in 1 CARTONLIQUID6 [hp_X] in 1mL11
54973-3243-14 Kids Cold and Cough Day and Night Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID118 mL6 [hp_X] in 1mL11
54973-3243-14 Kids Cold and Cough Day and Night Grape Flavor1 in 1 CARTONLIQUID6 [hp_X] in 1mL3
54973-3243-14 Kids Cold and Cough Day and Night Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID118 mL6 [hp_X] in 1mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-32434 KIDS COLD N COUGH GRAPE FLAVOR (ONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, AND SULFUR) LIQUID [HYLAND'S INC.]15Current NDC, Legacy NDC, 8 package rows20240711_798e2a4d-da2d-4bbd-a9b8-574490ef7357.zip
54973-32434 KIDS COLD AND COUGH DAY AND NIGHT GRAPE FLAVOR (ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN) KIT [HYLAND'S INC.]7Current NDC, Legacy NDC20250502_79f26bb5-15ad-e40a-e053-2991aa0aaab3.zip
54973-32434 KIDS COLD AND COUGH DAY AND NIGHT GRAPE FLAVOR (ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN) KIT [HYLAND'S INC.]3Current NDC, Legacy NDC20250223_1a297e56-4cb8-75ca-e063-6294a90a592b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54973-3243-1ML - Milliliter54973-32437d28e6b8-49a4-4b0d-a073-9caf269e10c612024-06-10

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 75 of 172 · 3,435 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TricitratesTRICITRATESChartwell RX, LLC2a80ea6b-6334-4c33-a35e-a5cb2939fbcb2025-04-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC6d43fa91-0940-437f-ba70-b2d3f977593e2025-04-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Ear RingALLIUM CEPA, ARGENTUM NITRICUM, ASARUM CANADENSE, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, CARTILAGO SUIS, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CYCLAMEN EUROPAEUM, DULCAMARA, GINKGO BILOBA, GOSSYPIUM HERBACEUM, GRAPHITES, KREOSOTUM, MUCOSA NASALIS SUIS, NATRUM SALICYLICUM, PHOSPHORUS, PLUMBUM METALLICUM, THERIDION, ZINCUM METALLICUMDeseret Biologicals, Inc.2a66f747-1417-45b9-955b-4dff9d6911e02025-04-22WarningsExact identifier
unii: 27YLU75U4W
unii: 492225Q21H
Arterioforce IARNICA MONTANA, LILIUM TIGRINUM, AURUM MURIATICUM, CACTUS GRANDIFLORUS, DIGITALIS PURPUREA, GLONOINUM, NUX VOMICA, VERATRUM ALBUMBioActive Nutritional, Inc.e20fd8ba-738e-4160-bc15-49b9430e7a712025-04-16WarningsExact identifier
unii: 269XH13919
Childrens Cold CrushACONITUM NAPELLUS, ALLIUM CEPA, BRYONIA ALBA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PULSATILLA, SAMBUCUS NIGRAGenexa Inc.32ece9d6-b346-6304-e063-6394a90a182d2025-04-16WarningsExact identifier
unii: 492225Q21H
unii: G0R4UBI2ZZ
COLDCALMONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLEBoironda32d4e3-f049-e7c8-e053-2a95a90a57902025-04-15WarningsExact identifier
unii: 269XH13919
unii: 492225Q21H
unii: I76KB35JEV
Umcka Fastactv BerryPELARGONUIM SIDOIDES, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS, BRYONIA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, PHOSPHORUS, ALPHA CFProSolutions Inceedab4b9-509b-3fe5-e053-2995a90a20272025-04-10WarningsExact identifier
unii: 27YLU75U4W
Nat Mur 6XSODIUM CHLORIDEHyland's Inc.dcf0e2ac-3b69-3ae4-e053-2a95a90aaf412025-04-10WarningsExact identifier
unii: 451W47IQ8X
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell RX, LLC978a5a9d-f0ca-4308-a84b-3b132263bbb82025-04-09Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Bio Co Enzyme PhaseACONITICUM ACIDUM, CIS-, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ADRENALINUM, , ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, ASCORBICUM ACIDUM, BARIUM OXALSUCCINICUM, BETA VULGARIS, CERIUM OXALICUM, CITRICUM ACIDUM, CYSTEINUM, FUMARICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM PHOSPHORICUM, NADIDUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PANTOTHENIC ACID, PROTEUS (MORGANI), PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM,Deseret Biologicals, Inc.6edee6eb-0ec9-4d2a-9dc9-dc2a6503a6db2025-04-08WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
TreeActiv Cystic Acne Spot TreatmentSULFURLeiluna LLCd1b81650-ccc4-49ed-9378-726b3a3a04c72025-04-08WarningsExact identifier
unii: 70FD1KFU70
Chamomilla 7XMATRICARIA RECUTITATrue Botanica, LLC227daf6d-95e6-b320-e063-6394a90a10c02025-04-07WarningsExact identifier
unii: G0R4UBI2ZZ
Allerpoll HPALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, NUX VOMICA, PHOSPHORUS, PULSATILLA (VULGARIS), SOLIDAGO VIRGAUREA, SULPHURBioActive Nutritional, Inc.e991a50a-2af8-496d-8082-00f579eeaae62025-04-03WarningsExact identifier
unii: 27YLU75U4W
unii: 269XH13919
unii: 492225Q21H
unii: 70FD1KFU70
unii: I76KB35JEV
Jointforce A-HPAPIS MELLIFICA, BRYONIA (ALBA), CAUSTICUM, COLCHICUM AUTUMNALE, KALMIA LATIFOLIA, LEDUM PALUSTRE, PULSATILLA (VULGARIS), RHODODENDRON CHRYSANTHUM, RHUS TOXBioActive Nutritional, Inc.23a88257-d545-4d34-94c3-760fb2e915c02025-04-03WarningsExact identifier
unii: I76KB35JEV
Sulfur Spot TreatmentSULFUR ACNE TREATMENTBanuskin, Inc.31e527e0-ce37-e920-e063-6394a90ac8272025-04-03WarningsExact identifier
unii: 70FD1KFU70
Genexa StressACONITUM NAPELLUS, CALCAREA CARBONICA, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NUX VOMICA, PASSIFLORA INCARNATA, VALERIANA OFFICINALISGenexa Inc.b86a2e37-fbc0-7c31-e053-2a95a90ad5d02025-04-02WarningsExact identifier
unii: 269XH13919
SleepologyALFALFA, AVENA SATIVA, CHAMOMILLA, ESCHSCHOLTZIA CALIFORNICA, GELSEMIUM SEMPERVIRENS, NUX MOSCHATA, PASSIFLORA INCARNATA, PIPER METHYSTICUM, VALERIANA OFFICINALISGenexa Inc.1e11f655-374c-59ac-e054-00144ff8d46c2025-04-02WarningsExact identifier
unii: G0R4UBI2ZZ
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Respiforce AARNICA MONTANA, ASCLEPIAS TUBEROSA, ERIODICTYON CALIFORNICUM, EUCALYPTUS GLOBULUS, LOBELIA INFLATA, PLANTAGO MAJOR, TRIFOLIUM PRATENSE, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CARBO VEGETABILIS, GRINDELIA, KALI CARBONICUM, NATRUM SULPHURICUM, PULSATILLA,BioActive Nutritionale9360698-bffb-4c91-b019-22e1e56704ee2025-04-02WarningsExact identifier
unii: I76KB35JEV
Prostatone HPCLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (VULGARIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISBioActive Nutritional, Inc2ccf602f-734a-4b2d-8d89-c410293f9eb92025-04-02WarningsExact identifier
unii: I76KB35JEV

Reported adverse events (FAERS/openFDA)#

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