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 36 of 50 · 989 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, THUJA OCCIDENTALISEnergique, Inc.3cdddbe5-e3d2-4629-a045-868e18183f1d2023-12-19WarningsExact identifier
unii: 8E272251DI
unii: ZW3Z11D0JV
unii: T4423S18FM
Mold AntigensALTERNARIA TENUIS NEES, ASPERGILLUS NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, TORULA CEREVISIAE, MUCOR RACEMOSUS, ARSENICUM ALBUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, RHIZOPUS NIGRICANSEnergique, Inc.d320a51f-13c0-423a-a7fe-ff88b56678ac2023-12-13WarningsExact identifier
unii: 8E272251DI
Dairy AntigensAMERICAN CHEESE, BLUE CHEESE, BRIE CHEESE, CHEDDAR CHEESE, COTTAGE CHEESE, GOAT MILK, LAC VACCINUM, SWISS CHEESE, CALCAREA CARBONICA, SEPIA, SULPHUREnergique, Inc.8f7aaae2-f764-461c-a242-6d22baf86f972023-12-04WarningsExact identifier
unii: 2E32821G6I
Oligo Bio IodineCHELIDONIUM MAJUS, IODIUM, LYCOPUS VIRGINICUS, GINKGO BILOBA, PINUS SYLVESTRIS, FUCUS VESICULOSUS, SPONGIA TOSTA, GERMANIUM SESQUIOXIDE, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), CYSTEINUM, MANGANESE GLUCONATE, ALPHA-KETOGLUTARICUM ACIDUM, CALCAREA CARBONICA, FERRUM IODATUM, FUMARICUM ACIDUM, KALI IODATUM, NATRUM OXALACETICUM, PULSATILLA (VULGARIS), ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, EUGENOL, FORMALINUM, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM METALLICUM, NICCOLUM METALLICUM,BioActive Nutritional, Inc.2f4f53a9-6294-4014-9898-72023b9506f52023-12-01WarningsExact identifier
unii: 2E32821G6I
Femstat CECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.420119ca-f2bf-40e3-9e40-00498724c2282023-11-30WarningsExact identifier
unii: 8E272251DI
unii: ZW3Z11D0JV
EndoparGLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, OOPHORINUM (SUIS), ORCHITINUM (BOVINE), PINEAL GLAND, THYROIDINUM, ARSENICUM ALBUM, BARYTA CARBONICA, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PULSATILLA (PRATENSIS)Energique, Inc.06375c3e-cc05-4450-9117-1d3dc72636eb2023-11-21WarningsExact identifier
unii: 8E272251DI
Bone LiquescenceTARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, CALCAREA MURIATICA, EQUISETUM ARVENSE, JUGLANS NIGRA, SESAME OIL, CALCAREA SULPHURICA, HEPAR SUIS, KIDNEY (SUIS), MEDULLA OSSIS SUIS, MENADIONE, THYROIDINUM (BOVINE), VITAMIN A, VITAMIN D3, CALCAREA PHOSPHORICA, CALCAREA CARBONICA, CALCAREA FLUORICA, MANGANUM METALLICUM, NICCOLUM METALLICUM, MAGNESIUM METALLICUMNutritional Specialties, Inc.5d323e16-e9a5-4933-9593-285c7b3c54ce2023-11-17WarningsExact identifier
unii: 2E32821G6I
Kali bichromicumPOTASSIUM DICHROMATEBoiron8605b9a8-ebcd-7a83-e053-2a91aa0af0ea2023-11-13Exact identifier
unii: T4423S18FM
Kali bichromicumPOTASSIUM DICHROMATEBoiron8605f7a1-daea-a7f0-e053-2a91aa0adcd72023-11-13Exact identifier
unii: T4423S18FM
Kali bichromicumPOTASSIUM DICHROMATEBoiron860669cb-694b-c98d-e053-2991aa0aa0e32023-11-13Exact identifier
unii: T4423S18FM
Kali bichromicumPOTASSIUM DICHROMATEBoiron8605b9a8-ebdd-7a83-e053-2a91aa0af0ea2023-11-13Exact identifier
unii: T4423S18FM
Kali bichromicumPOTASSIUM DICHROMATEBoiron85cee945-5aae-3be4-e053-2991aa0aa1812023-11-13Exact identifier
unii: T4423S18FM
Kali bichromicumPOTASSIUM DICHROMATEBoiron860533b3-4126-0cbf-e053-2a91aa0aa6992023-11-13Exact identifier
unii: T4423S18FM
Kali bichromicumPOTASSIUM DICHROMATEBoiron860626bf-19f5-aa92-e053-2991aa0a91192023-11-13Exact identifier
unii: T4423S18FM
Kali bichromicumPOTASSIUM DICHROMATEBoironafe6d5f0-7b80-11e6-ae49-424c583030312023-11-13Exact identifier
unii: T4423S18FM
Calcarea carbonicaOYSTER SHELL CALCIUM CARBONATE, CRUDEBoiron85042c86-1b04-e3e8-e053-2991aa0a1f1a2023-11-09Exact identifier
unii: 2E32821G6I
Calcarea carbonicaOYSTER SHELL CALCIUM CARBONATE, CRUDEBoiron848c237e-ea93-301a-e053-2991aa0a66d52023-11-09Exact identifier
unii: 2E32821G6I
Calcarea carbonicaOYSTER SHELL CALCIUM CARBONATE, CRUDEBoiron8503ff58-b00c-39d2-e053-2991aa0a89982023-11-09Exact identifier
unii: 2E32821G6I
Calcarea carbonicaOYSTER SHELL CALCIUM CARBONATE, CRUDEBoiron8503e449-8c0a-4aa0-e053-2991aa0aeff92023-11-09Exact identifier
unii: 2E32821G6I
Calcarea carbonicaOYSTER SHELL CALCIUM CARBONATE, CRUDEBoironb2fcb9e0-79fe-11e6-a551-424c583030312023-11-09Exact identifier
unii: 2E32821G6I

Reported adverse events (FAERS/openFDA)#

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