FDA.reportPublic FDA data

NDC 54973-4115-01 - Kids Stuffy Nose and Sinus

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
54973-4115
Requested NDC
54973-4115-01
Package NDCs from labels
54973-4115-1, 54973-4115-01
Manufacturer
Hyland's Consumer Health Inc.
Effective date
2022-08-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hyland's Naturals Kids Stuffy Nose & SinusHyland's Consumer Health Inc.2022-08-25HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4115-1Kids Stuffy Nose and Sinus50 in 1 BOTTLE, PLASTICTABLET501
54973-4115-1Kids Stuffy Nose and Sinus1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4115KIDS STUFFY NOSE AND SINUS (OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, PULSATILLA PRATENSIS WHOLE) TABLET [HYLAND'S CONSUMER HEALTH INC.]1Current NDC, Legacy NDC, 2 package rows20221201_e7157883-6b23-b61c-e053-2995a90afdc2.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 40 of 50 · 989 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrastis canadensisGOLDENSEALBoiron85b9d833-1f50-32a9-e053-2991aa0a4a9c2023-04-11Exact identifier
unii: ZW3Z11D0JV
EnviroforceSARSAPARILLA (SMILAX REGELII), XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, AURUM METALLICUM, CARBO ANIMALIS, CAUSTICUM, IODIUM, SULPHUR, THUJA OCCIDENTALISBioActive Nutritional, Inc.9f364896-8626-49db-aef9-6fbf15e46d8f2023-04-10WarningsExact identifier
unii: ZW3Z11D0JV
HPYL PLUSANGELICA ARCHANGELICA, GERANIUM MACULATUM, HYDRASTIS CANADENSIS, SINAPIS NIGRA, SYMPHYTUM OFFICINALE, RATANHIA, ACETICUM ACIDUM, CARBOLICUM ACIDUM, ORNITHOGALUM UMBELLATUM, ABIES CANADENSIS, ANACARDIUM ORIENTALE, BISMUTHUM SUBNITRICUM, CONDURANGO, GRAPHITES, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, MEZEREUM, URANIUM NITRICUM, EUPHORBIUM OFFICINARUM, NUX VOMICADeseret Biologicals, Inc.a13a91e0-572a-4f9c-b80e-f161f055e6fd2023-04-10WarningsExact identifier
unii: ZW3Z11D0JV
Fat Loss Activation ComplexFUCUS VESICULOSUS, KALI CARBONICUM, ASAFOETIDA, CAPSICUM ANNUUM, PHYTOLACCA DECANDRA, AURUM METALLICUM, CALCAREA CARBONICA, FERRUM METALLICUM, GRAPHITESHealth Masters LLC61fc35d1-007e-4e9d-af6e-be2869a449972023-04-06WarningsExact identifier
unii: 2E32821G6I
GlutenstatALFALFA, ZINGIBER OFFICINALE, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, BARLEY (GRAIN), CARBO VEGETABILIS, GLYPHOSATE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN), GLUTENEnergique, Inc.c6b867b6-74d9-4725-90d7-7d5d1fe611212023-04-05WarningsExact identifier
unii: ZW3Z11D0JV
Hydrastis canadensisGOLDENSEALBoiron85b9e0fc-cb66-4f3b-e053-2a91aa0a59972023-03-27Exact identifier
unii: ZW3Z11D0JV
Kali bichromicumPOTASSIUM DICHROMATEBoiron860585aa-4819-1a2f-e053-2991aa0aa1a22023-03-27Exact identifier
unii: T4423S18FM
Metabolic Correction BlendFOENICULUM VULGARE, AMMONIUM BROMATUM, FUCUS VESICULOSUS, LECITHIN (DERIVED FROM EGG), CAPSICUM ANNUUM, GALIUM APARINE, HYPOTHALAMUS SUIS, KALI BICHROMICUM, LAC DEFLORATUM (NSPC), PHYTOLACCA DECANDRA, PROGESTERONE, THYROIDINUM (BOVINE), PITUITARUM POSTERIUM (BOVINE), ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, CALCAREA CARBONICA, FERRUM METALLICUM, GRAPHITES, ADRENALINUM, PHOSPHORUSIHA Distribution, LLCe8ec4f7e-c9dd-46dd-a9ee-2b8b7bcea9a82023-03-21WarningsExact identifier
unii: 2E32821G6I
unii: T4423S18FM
Myco Immuno NosodeDU HUO (ANGELICA PUBESCENS), ANGELICA ARCHANGELICA, KALI MURIATICUM, RADIX SILERIS (SAPOSHNIKOVIA DIVARICATA), YUCCA FILAMENTOSA, ACHYRANTHES BIDENTATA, ANGELICA SINENSIS, LIGUSTICUM PORTERI, PANAX GINSENG, RHUS TOX, HYDRASTIS CANADENSIS, UNCARIA TOMENTOSA, CARTILAGO SUIS, HORDEUM VULGARE, OXALICUM ACIDUM, ARNICA MONTANA, LATRODECTUS MACTANS, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, BORRELIA BURGDORFERI, BABESIA MICROTINutritional Specialties, Inc.34dc93af-0c39-4e06-a8d6-9e1ccc77aa232023-03-17WarningsExact identifier
unii: ZW3Z11D0JV
Calcarea carbonicaOYSTER SHELL CALCIUM CARBONATE, CRUDEBoiron849bcf33-d5c3-438d-e053-2a91aa0a28652023-03-09Exact identifier
unii: 2E32821G6I
Calcarea carbonicaOYSTER SHELL CALCIUM CARBONATE, CRUDEBoiron8503e449-8b91-4aa0-e053-2991aa0aeff92023-03-09Exact identifier
unii: 2E32821G6I
Hydrastis canadensisGOLDENSEALBoiron85ba819e-830f-0c84-e053-2991aa0a51182023-02-20Exact identifier
unii: ZW3Z11D0JV
Kali bichromicumPOTASSIUM DICHROMATEBoiron86052ecc-cff4-51cf-e053-2a91aa0a36ae2023-02-20Exact identifier
unii: T4423S18FM
Calcarea carbonicaOYSTER SHELL CALCIUM CARBONATE, CRUDEBoiron8503ad98-0f73-2a2d-e053-2a91aa0aa36a2023-02-20Exact identifier
unii: 2E32821G6I
CitriDropsASCORBICUM ACIDUM, CITRUS LIMONUN, PULSATILLA, SINAPIS NIGRA, LUFFA OPERCULATA, BERBERIS VULGARIS, EUPHORBIUM OFFICINARUM, GUAIACUM, HEPAR SULPHURIS CALCAREUM, MERCURIUS SULPHURATU RUBERMicro Balance Health Productsf529aef5-ed57-7b26-e053-2995a90a54302023-02-20WarningsExact identifier
unii: 8E272251DI
EyeClear ProCALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEASilver Star Brandsf4d4943b-cb78-aa71-e053-2a95a90ac6382023-02-16WarningsExact identifier
unii: 2E32821G6I
HKIATROPINUM SULPHURICUM, BENZOICUM ACIDUM, BERBERIS VULGARIS, CALCAREA CARBONICA, COLOCYNTHIS, COCCUS CACTI, LAPIS ALBUS, LITHIUM CARBONICUM, LYCOPODIUM CLAVATUM, ORYCTOLAGUS CUNICULUS KIDNEY, RUBIA TINCTORUM, SARSAPARILLA, URTICA URENSSeroyal USA26e048f5-8e87-51e6-e054-00144ff88e882023-01-31WarningsExact identifier
unii: 2E32821G6I
HTHYCALCAREA CARBONICA, CALCAREA IODATA, FERRUM IODATUM, FUCUS VESICULOSUS, HEPAR SULPHURIS CALCAREUM, KALI IODATUM, LAPIS ALBUS CALCIUM FLUOSILICATE, ORYCTOLAGUS CUNICULUS (RABBIT) ADRENAL GLAND, ORYCTOLAGUS CUNICULUS (RABBIT) PITUITARY GLAND, ORYCTOLAGUS CUNICULUS (RABBIT) SPLEEN, ORYCTOLAGUS CUNICULUS (RABBIT) THYMUS GLAND, ORYCTOLAGUS CUNICULUS (RABBIT) THYROID GLAND, SPONGIA TOSTASeroyal USA079bede5-f618-03ed-e054-00144ff8d46c2023-01-30WarningsExact identifier
unii: 2E32821G6I
Pain and Fatigue ReliefACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, CONIINUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI BICHROMICUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, URICUM ACIDUMThe Magni Company7c689153-2002-421d-b573-76b0052550e02023-01-26WarningsExact identifier
unii: T4423S18FM
Kali bichromicumPOTASSIUM DICHROMATEBoiron860523b4-c0df-3556-e053-2991aa0aa5e82023-01-24Exact identifier
unii: T4423S18FM

Reported adverse events (FAERS/openFDA)#

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