FDA.reportPublic FDA data

NDC 53499-0803-05 - Sambucus Flu Relief

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
53499-0803
Requested NDC
53499-0803-05
Package NDCs from labels
53499-0803-5, 53499-0803-05
Manufacturer
Schwabe North America, Inc.
Effective date
2025-12-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sambucus Flu ReliefSchwabe North America, Inc.2025-12-08HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-0803-5Sambucus Flu Relief1 in 1 BOXSYRUP14
53499-0803-5Sambucus Flu Relief120 mL in 1 BOTTLE, PLASTICSYRUP1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-0803SAMBUCUS FLU RELIEF (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOP ) SYRUP [SCHWABE NORTH AMERICA, INC.]3Current NDC, 2 package rows20240404_ca7d57b0-ffae-415f-a959-b0c88ae7dd40.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 80 of 249 · 4,965 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RET Pituitary/Sex 7012RET PITUITARY/SEXProfessional Complementary Health Formulas5081185c-1598-4bf5-b47b-b15135c453fb2026-01-08WarningsExact identifier
unii: 639KR60Q1Q
Perfumox 6028PERFUMOXProfessional Complementary Health Formulasd27ac082-12fc-477d-a5c0-bb74f29c0e602026-01-08WarningsExact identifier
unii: 27YLU75U4W
Sleep Disorder Drops 2152SLEEP DISORDER DROPSProfessional Complementary Health Formulas55af88df-8e5a-4e84-a8f6-fc3063d913812026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: U0NQ8555JD
Asbestox 6005ASBESTOXProfessional Complementary Health Formulas90bc0d00-01e4-4134-809e-e216fd09852a2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Amoeba/Protozoan Detox 6046AMOEBA/PROTOZOAN DETOXProfessional Complementary Health Formulaseebc5855-30e0-4866-83dc-8700f995fa492026-01-08WarningsExact identifier
unii: 62I3C8233L
unii: S546YLW6E6
Sciatica Drops 2059SCIATICA DROPSProfessional Complementary Health Formulasbced3ea7-18fb-41eb-bc41-ac043cf4b02f2026-01-08WarningsExact identifier
unii: U0NQ8555JD
Thio Combination 9306THIO COMBINATIONProfessional Complementary Health Formulas36e84795-bfb4-4483-9a2c-e14131ce1bea2026-01-08WarningsExact identifier
unii: 639KR60Q1Q
Rhus Tox Combination 9242RHUS TOX COMBINATIONProfessional Complementary Health Formulas3e4dcb00-ad32-4b52-85c5-4d4ec79eff0f2026-01-08WarningsExact identifier
unii: T7J046YI2B
RET Kidney 7005RET KIDNEYProfessional Complementary Health Formulas017f4c37-3eec-4078-9ce6-aca52fd4974d2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Bronchitis Drops 2170BRONCHITIS DROPSProfessional Complementary Health Formulase42c1a4e-6954-4493-9f64-f67137cb2b412026-01-08WarningsExact identifier
unii: 62I3C8233L
unii: S546YLW6E6
Solvent/Small Ring Combination 9317SOLVENT/SMALL RING COMBINATIONProfessional Complementary Health Formulas01a1b313-3edb-4907-9d9b-bb1d1061b4ef2026-01-08WarningsExact identifier
unii: 639KR60Q1Q
Liver Stim Liquescence 3015LIVER STIM LIQUESCENCEProfessional Complementary Health Formulas59ccef5a-9e70-4e47-8cdf-dedc27dea51b2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Baryta Combination 9209BARYTA COMBINATIONProfessional Complementary Health Formulascca7da01-b28b-46c3-b025-d0bd12074aa12026-01-08WarningsExact identifier
unii: U0NQ8555JD
Peroxide Combination 9316PEROXIDE COMBINATIONProfessional Complementary Health Formulas9044ff79-2f33-41bc-a630-4e02a72219482026-01-08WarningsExact identifier
unii: 639KR60Q1Q
Glucose Drops 2031GLUCOSE DROPSProfessional Complementary Health Formulas21de3b86-be2b-4f71-9384-78ebc42ec0872026-01-08WarningsExact identifier
unii: 6YSS42VSEV
Gout Drops 2080GOUT DROPSProfessional Complementary Health Formulas30696295-01f6-4a50-a932-76fdc7c0501a2026-01-08WarningsExact identifier
unii: T7J046YI2B
Gelsemium Combination 9223GELSEMIUM COMBINATIONProfessional Complementary Health Formulas9790600a-929b-48ce-af11-4b7157c2d31a2026-01-08WarningsExact identifier
unii: 639KR60Q1Q
Anti-Scar Drops 2084ANTI-SCAR DROPSProfessional Complementary Health Formulasad0e9159-ed68-48aa-a7d1-7ff5c32ec3042026-01-08WarningsExact identifier
unii: U0NQ8555JD
Restless Leg Drops 2172RESTLESS LEG DROPSProfessional Complementary Health Formulas73822225-f10c-4d2a-8cd8-ea31dd2b27892026-01-08WarningsExact identifier
unii: U0NQ8555JD
Consciousness Stim Formula 2099CONSCIOUSNESS STIM FORMULAProfessional Complementary Health Formulas210f3135-9492-4c1c-a438-b435b33df6df2026-01-08WarningsExact identifier
unii: 27YLU75U4W

Reported adverse events (FAERS/openFDA)#

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