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 18 of 180 · 3,594 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PancreaplexCHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, NUX MOSCHATA, RHEUM (PALMATUM), SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, ZINGIBER OFFICINALE, HYDRASTIS CANADENSIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOPHYSIS SUIS, PANCREAS SUIS, THYROIDINUM (SUIS), PHASEOLUS, PHOSPHORICUM ACIDUM, PHOSPHORUSBioActive Nutritional, Inc.4f7fbb76-79c0-4c1e-aa30-a39492db63d82026-04-03WarningsExact identifier
unii: 27YLU75U4W
unii: 2788Z9758H
unii: ZW3Z11D0JV
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Chestal Kids Cold and Cough HoneySOLANUM DULCAMARA TOP, FERROSOFERRIC PHOSPHATE, GOLDENSEAL, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEEDBoiron4e8ff89e-f9e8-8618-e063-6294a90a6b3e2026-04-03WarningsExact identifier
unii: 269XH13919
unii: ZW3Z11D0JV
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEHospira, Inc.376093e7-e09e-4a57-3199-195e452518662026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lymphastat FECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, ABIES NIGRA, BORAX, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (VULGARIS), SEPIA, THUJA OCCIDENTALIS, SKATOLUM, CANDIDA ALBICANSEnergique, Ince23f7017-daf0-4dc3-99c4-9eabc217a8bc2026-04-02WarningsExact identifier
unii: 27YLU75U4W
unii: 269XH13919
unii: I76KB35JEV
Liver Gallbladder HPBELLADONNA, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEPTANDRA VIRGINICA, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PTELEA TRIFOLIATA, PULSATILLA (PRATENSIS), VERATRUM ALBUMEnergique, Inc.91f2500c-411f-4ef9-81f7-76e93d9bb3a52026-04-02WarningsExact identifier
unii: 27YLU75U4W
unii: 269XH13919
Migraine and HeadacheIRIS VERSICOLOR ROOT AND SODIUM CHLORIDEForces of Nature0dd2f2e2-78e2-435e-b7b2-ca590953ff942026-04-01WarningsExact identifier
unii: 451W47IQ8X
CirculationNIACIN, NICOTINAMIDUM, ARNICA MONTANA, CAMPHORA, NUX VOMICA, STROPHANTHUS HISPIDUS, VERATRUM ALBUM, ADRENALINUM, AESCULUS HIPPOCASTANUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HELODERMA (HORRIDUS), RHUS TOX, TABACUMNutritional Specialties, Inc.220bbbf3-d54d-4222-b540-e197927ab8bc2026-04-01WarningsExact identifier
unii: 269XH13919
IndustrioxBERBERIS VULGARIS, TARAXACUM OFFICINALE, AMMONIUM CARBONICUM, CAMPHORA, SPINACIA, SULPHURICUM ACIDUM, NUX VOMICA, ACETONE, BENZINUM, BUTYL METHACRYLATE, CALCAREA CARBONICA, LACHESIS MUTUS, METHYL ETHYL KETONE, NAPHTHALINUM, PLUMBUM METALLICUM, TRICHLOROETHYLENE, FORLMALINUM, MTBE (TERT-BUTYL METHYL ETHER), PETROLEUM, CARBONEUM CHLORATUMNutritional Specialties, Inc.d77a58f8-68c3-4772-b938-473b203a1d472026-04-01WarningsExact identifier
unii: 269XH13919
Cough HPARSENICUM ALBUM, BRYONIA (ALBA), CUPRUM ACETICUM, DROSERA (ROTUNDIFOLIA), IPECACUANHA, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SPONGIA TOSTABioActive Nutritional, Inc.1e65f5de-3735-4ac7-b2ef-a91a68ffa6832026-03-31WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
Cold Sore FormulaDULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM MURIATICUM, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODENutritional Specialties, Inc.f4e7e469-baaf-4c61-af44-80b0832eadf02026-03-31WarningsExact identifier
unii: 2788Z9758H
unii: 451W47IQ8X
Sodium Chloride Normal SaltSODIUM CHLORIDETWIN MED LLC10230c8a-e5e5-44f1-b41d-80930899d6b92026-03-31WarningsExact identifier
unii: 451W47IQ8X
H-Allergy FormulaALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARUM TRIPHYLLUM, ARUNDO MAURITANICA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, NATRUM MURIATICUM, SOLIDAGO VIRGAUREA, STICTA PULMONARIA, SULPHUR, TRIFOLIUM PRATENSE, WYETHIA HELENIOIDESHealing Natural Oils LLC4e586360-b3c4-1ce0-e063-6394a90ab6b82026-03-31WarningsExact identifier
unii: 451W47IQ8X
unii: 492225Q21H
unii: 70FD1KFU70
Acne HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMBioActive Nutritional, Inc.2ab4ff53-4274-40c7-b05c-44d918d809be2026-03-31WarningsExact identifier
unii: 451W47IQ8X
unii: 70FD1KFU70
unii: I76KB35JEV
Cold Sore FormulaDULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM HYPOCHLOROUS, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODENutritional Specialties, Inc.ad6a08ec-5eba-405b-8a07-79ac86ab3e7a2026-03-31WarningsExact identifier
unii: 2788Z9758H
unii: 451W47IQ8X
CirculatoneFAGOPYRUM ESCULENTUM, MAGNESIA MURIATICA, CITRUS BIOFLAVONOIDS, HEART (SUIS), THYROIDINUM (SUIS), ARSENICUM IODATUM, AURUM MURIATICUM, BARYTA MURIATICA, CALCAREA IODATA, CHOLESTERINUM, CONIUM MACULATUM, KALI IODATUM, PLUMBUM METALLICUM, ARNICA MONTANA, PHOSPHORUSBioActive Nutritional, Inc.465fb3c6-88e6-4099-a26a-33991ec5a1062026-03-31WarningsExact identifier
unii: 27YLU75U4W
LymphoplexMYRRHA, TRIGONELLA FOENUM-GRAECUM, PINUS SYLVESTRIS, LYMPH (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRANGEA ARBORESCENS, PHYTOLACCA DECANDRA, SILICEABioActive Nutritional, Inc.624f35db-291e-4e7f-a2c9-ae319717157a2026-03-30WarningsExact identifier
unii: 1MBW07J51Q
Redness ReliefGLYCERIN, NAPHAZOLINE HCLPharmadel LLC4c113bb9-814f-d92d-e063-6294a90a83022026-03-30WarningsExact identifier
unii: PDC6A3C0OX
Moisture OysterGLYCERINMoisture Oyster Inc4e45317a-437f-4d88-e063-6294a90a98d02026-03-30WarningsExact identifier
unii: PDC6A3C0OX
Endoplex FCIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, GLYCYRRHIZA GLABRA, XANTHOXYLUM FRAXINEUM, ADRENALINUM, CEREBRUM SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS (SUIS), OOPHORINUM (SUIS), PINEAL (SUIS), THYROIDINUM (SUIS), PULSATILLA (VULGARIS), SEPIABioActive Nutritional, Inc.bfe6d42a-a3e5-44b3-ab8f-b08ad4e2b66f2026-03-30WarningsExact identifier
unii: 2788Z9758H
unii: I76KB35JEV

Reported adverse events (FAERS/openFDA)#

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