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 43 of 50 · 989 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrastis CanadensisHYDRASTIS CANADENSISHahnemann Laboratories, INC.ea2cc59f-448f-22f8-e053-2995a90a4a302022-10-03Exact identifier
unii: ZW3Z11D0JV
Dr Talbots Infant Mucus Cold ReliefEUPATORIUM PERF 12X,HEPAR SULPHURIS CALCAREUM 12X,KALI BICHROMICUM 12X,MARRUBIUM VULGARE 12X,PHOSPHORUS 30X,PULSATILLA 12X,RUMEX CRISPUS 12X,SAMBUCUS NIGRA 12X,CALCAREA SULPHURICA 12X,FERRUM PHOSPHORICUM 12XTalbots Pharmaceuticals Family Products, LLC.e8917c54-f4c2-3427-e053-2995a90adbf22022-09-13WarningsExact identifier
unii: T4423S18FM
Kali BichromicumKALI BICHROMICUMHahnemann Laboratories, INC.e81be440-31a3-53e1-e053-2995a90ace9e2022-09-07Exact identifier
unii: T4423S18FM
Kids Stuffy Nose and SinusOYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, PULSATILLA PRATENSIS WHOLEHyland's Consumer Health Inc.e7157883-6b23-b61c-e053-2995a90afdc22022-08-25WarningsExact identifier
ndc (package): 54973-4115-1
ndc (product): 54973-4115
ndc11 (package): 54973411501
spl id: e7157883-6b24-b61c-e053-2995a90afdc2
spl set id: e7157883-6b23-b61c-e053-2995a90afdc2
unii: 2E32821G6I
unii: 8E272251DI
unii: ZW3Z11D0JV
unii: T4423S18FM
Hendel Sinus ReliefECHINACEA PURPUREA, ANEMONE PULSATILLA, EUPATORIUM PERFOLIATUM FLOWERING, GOLDENSEAL, POTASSDICHROMATE, LUFFA OPERCULATA FRUIT, POTASSIUM IODIDE, CALCIUM SULFIDE AND MERCURIC SULFIDEMediNatura Inc819425a8-b4ec-4049-95cb-187f6729dde52022-08-18WarningsExact identifier
unii: ZW3Z11D0JV
unii: T4423S18FM
Kids Cold and Cough Nighttime Grape FlavorONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFURHyland's Consumer Health Inc.e676dbb7-212f-47e3-e053-2995a90af4e12022-08-17WarningsExact identifier
unii: ZW3Z11D0JV
Kids Cold and Cough Daytime Grape FlavorONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFURHyland's Consumer Health Inc.e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d2022-08-16WarningsExact identifier
unii: ZW3Z11D0JV
ReBoostAPIS MELLIFERA, ATROPA BELLADONNA, ZINC GLUCONATE, BAPTISIA TINCTORIA ROOT, ULMUS RUBRA BARK, SULFUR, ZINC ACETATE ANHYDROUS,VINCETOXICUM HIRUNDINARIA ROOT AND CAIRINA MOSCHATA HEART/LIVERMediNaturad26137fa-6916-473a-9518-b0613e5cbcce2022-08-08WarningsExact identifier
unii: ZW3Z11D0JV
BHI SinusEUPHORBIA RESINIFERA RESIN, GOLDENSEAL, POTASSIUM DICHROMATE, POTASSIUM IODIDE, PHOSPHORUS, PULSATILLA VULGARIS, AND THUJA OCCIDENTALIS LEAFY TWIGMediNatura Inccb11ccaf-7569-4cf3-8064-811c7db110012022-08-08WarningsExact identifier
unii: ZW3Z11D0JV
unii: T4423S18FM
ReBoostSILVER NITRATE,EUPHORBIA RESINIFERA RESIN, CALCIUM SULFIDE, GOLDENSEAL, POTASSIUM DICHROMATE,LUFFA OPERCULATA FRUIT, SODIUM CARBONATE, ECHINACEA UNSPECIFIED, CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE AND PULSATILLA VULGARISMediNaturacb8a8d2a-d9d2-4a71-9279-c5641a9126c62022-07-19WarningsExact identifier
unii: ZW3Z11D0JV
unii: T4423S18FM
Adrenal SupportARALIA QUINQUEFOLIA, HUMULUS LUPULUS, ADRENALINUM, CORTISONE ACETICUM, SELENIUM METALLICUM, THYROIDINUM (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, FERRUM METALLICUM, NUX VOMICA, PHOSPHORUS, SEPIA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.37a7f63c-4241-492b-af7c-7e5bbe0a08892022-06-21WarningsExact identifier
unii: 2E32821G6I
Calcarea CarbonicaCALCAREA CARBONICAHahnemann Laboratories, INC,df3a8618-e6bb-17f8-e053-2995a90a17db2022-05-17Exact identifier
unii: 2E32821G6I
UNDA 15ALLIUM CEPA, AURUM METALLICUM, EUCALYPTUS GLOBULUS, INULA HELENIUM, TRIGONELLA FOENUM-GRAECUMSeroyal USA16ee1833-db7c-46fe-e054-00144ff88e882022-04-28WarningsExact identifier
unii: ZW3Z11D0JV
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe Mexico, S.A. de C.V.3e2e5f52-db54-4635-83a8-a67a683c093c2022-03-22WarningsExact identifier
unii: ZW3Z11D0JV
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe North America, Inc.94de9ce3-6ee9-4322-bda2-0b4391f09d872022-03-22WarningsExact identifier
unii: ZW3Z11D0JV
Ear CareECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUMNewton Laboratories, Inc.da807eb3-34a3-61b9-e053-2995a90a0e212022-03-18WarningsExact identifier
unii: ZW3Z11D0JV
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da80a5ea-f603-719e-e053-2995a90a97102022-03-18WarningsExact identifier
unii: ZW3Z11D0JV
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da81b21a-090a-dabf-e053-2995a90aa05e2022-03-18WarningsExact identifier
unii: ZW3Z11D0JV
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da821d05-b2f0-3582-e053-2a95a90afe592022-03-18WarningsExact identifier
unii: ZW3Z11D0JV
Cough - AirwayINFLUENZA A VIRUS, INFLUENZA B VIRUS, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB.,KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPANewton Laboratories, Inc.92ae84ae-559c-79b8-e053-2a95a90aa79f2022-03-17WarningsExact identifier
unii: ZW3Z11D0JV
unii: T4423S18FM

Reported adverse events (FAERS/openFDA)#

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