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 8 of 53 · 1,043 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ECHINACEAECHINACEA ANGUSTIFOLIA, HAMAMMELIS VIRGINIANA, CALCAREA PHOSPHORICA, HYDRASTIS CANADANESIS, SENEGA OFFICINALIS, SILICEA, CONIUM, AURUM MURIATICUM NATRONATUM, CALCAREA CARBONICA, FUCUS VESICULOSUS, LACHESIS MUTUSMarco Pharma International LLC.7efadb70-99e4-428b-a8ef-a2797327c6fa2026-01-12WarningsExact identifier
unii: 2E32821G6I
unii: ZW3Z11D0JV
AcusineHYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, EPHEDRA VULGARIS, MEZEREUM, PETROLEUM, PULSATILLA, THUJA OCCIDENTALISMarco Pharma International LLCd3edf95a-547c-79e4-e053-2a95a90a91b82026-01-12WarningsExact identifier
unii: ZW3Z11D0JV
LuffaLUFFA, HYDRASTIS CANADENSIS, MERCURIUS SULPH. RUB, ALLIUM CEPA, NATRUM MURITICUM, PHOSPHORUS, EUPATORIUM PERF, STICTAMarco Pharma International LLC.7dbb79de-c3f5-4245-884a-a6bd29bb861c2026-01-12WarningsExact identifier
unii: ZW3Z11D0JV
HeilenGALIUM APARINE, AGNUS CASTUS, APIS MELLIFICA, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, URTICA DIOICA, XANTHOXYLUM FRAXINEUM, FUCUS VESICULOSUS, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SARSAPARILLA (SMILAX REGELII), UBIDECARENONUM, CALCAREA CARBONICA, GRAPHITES, LYCOPODIUM CLAVATUM, ANACARDIUM ORIENTALE, COLCHICUM AUTUMNALE, NUX VOMICA, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), HISTAMINUM HYDROCHLORICUMHeilenef3f66f9-47bc-4fce-8950-ed2319bc30d62026-01-12WarningsExact identifier
unii: 2E32821G6I
unii: 8E272251DI
YeastCalmSODIUM BORATE,CALENDULA OFFICINALIS FLOWERING TOP,CANDIDA ALBICANS,GOLDENSEALLaboratoires Boirdoncd384b93-b803-8810-e053-2a95a90acdf02026-01-09WarningsExact identifier
unii: ZW3Z11D0JV
Metabolism ManagerASCLEPIAS VINCETOXICUM, ECHINACEA (ANGUSTIFOLIA), HYPOTHALAMUS SUIS, CEREBRUM SUIS, HEPAR SUIS, KIDNEY (SUIS), METHYLCOBALAMIN, PANCREAS SUIS, STOMACH (SUIS), AACG-A, AACG-B, CALCAREA CARBONICA, GAMBOGIA, GELSEMIUM SEMPERVIRENS, GRAPHITES, NUX VOMICA, PHYTOLACCA DECANDRA, 7-OXO-DEHYDROEPIANDROSTERONE-3BETA-ACETATE (7-KETO), ADENOSINUM TRIPHOSPHORICUM DINATRUM, INSULINUM (SUIS), SARCOLACTICUM ACIDUM, PROTEUS (VULGARIS)Healthsource of New England LLCa9662e0a-0a8b-4b0c-abe4-f3f4b6fbe7f82026-01-09WarningsExact identifier
unii: 2E32821G6I
Otitis Media Drops 2153OTITIS MEDIA DROPSProfessional Complementary Health Formulas9e8b60e9-0bd7-4c6c-99fa-cb87a9c831722026-01-08WarningsExact identifier
unii: 2E32821G6I
Renal Drops 5024RENAL DROPSProfessional Complementary Health Formulase598ae46-3b14-4dce-b7e0-abf159d102db2026-01-08WarningsExact identifier
unii: 2E32821G6I
Wet Eczema Drops 2136WET ECZEMA DROPSProfessional Complementary Health Formulas28f08a29-9b1a-4579-a56f-4cab7cdcfcb62026-01-08WarningsExact identifier
unii: 2E32821G6I
RET Large Intestine 7004RET LARGE INTESTINEProfessional Complementary Health Formulasf1d07d3b-be59-4021-a9cb-8cb9b5b2aff52026-01-08WarningsExact identifier
unii: 2E32821G6I
Low Vaccinosis Nosode 4024LOW VACCINOSIS NOSODEProfessional Complementary Health Formulasf347ac8f-ac05-46ef-91a3-9f7e000347682026-01-08WarningsExact identifier
unii: 2E32821G6I
Weight Management Formula 7534WEIGHT MANAGEMENT FORMULAProfessional Complementary Health Formulasf0406b63-7b97-4b2c-b976-75e8890818c62026-01-08WarningsExact identifier
unii: 2E32821G6I
Southeast Regional 1024SOUTHEAST REGIONALProfessional Complementary Health Formulas7a4ff3cf-6897-4cca-b907-556270642e042026-01-08WarningsExact identifier
unii: 5C5403N26O
Travel Immunization Detox 6033TRAVEL IMMUNIZATION DETOXProfessional Complementary Health Formulasb74abfad-fe22-476c-9692-07d66cc15ac52026-01-08WarningsExact identifier
unii: 2E32821G6I
Trees 2 1017TREES 2Professional Complementary Health Formulas601c8ffe-35c2-4dcc-a503-7d9b9998e2842026-01-08WarningsExact identifier
unii: 5C5403N26O
Intestine Drops 5009INTESTINE DROPSProfessional Complementary Health Formulas51298670-06bb-4b17-a7e5-3efd91717c1a2026-01-08WarningsExact identifier
unii: ZW3Z11D0JV
Vaccinosis Nosode 4004VACCINOSIS NOSODEProfessional Complementary Health Formulasdff675b3-6330-45d0-984c-526a8f44202b2026-01-08WarningsExact identifier
unii: 2E32821G6I
Degex Liquescence 3025DEGEX LIQUESCENCEProfessional Complementary Health Formulasb7697e21-3e5e-4a64-b557-8c186d5950db2026-01-08WarningsExact identifier
unii: ZW3Z11D0JV
Sinusitis Drops 2060SINUSITIS DROPSProfessional Complementary Health Formulas00469764-e0ab-45cf-8e61-6bdc67d31e542026-01-08WarningsExact identifier
unii: T4423S18FM
Wart Drops 2078WART DROPSProfessional Complementary Health Formulas05b3c208-d5c3-441a-b3c3-d3c4df2805cd2026-01-08WarningsExact identifier
unii: 2E32821G6I

Reported adverse events (FAERS/openFDA)#

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