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 81 of 249 · 4,965 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Parasites/Amoeba/Protozoan Nosode Combination 9402PARASITES/AMOEBA/PROTOZOAN NOSODE COMBINATIONProfessional Complementary Health Formulas0846f710-e652-4010-81b6-45a216b0c8c72026-01-08WarningsExact identifier
unii: 1W0775VX6E
unii: S546YLW6E6
Tartarus Combination 9259TARTARUS COMBINATIONProfessional Complementary Health Formulasb149cb95-26e1-4950-93af-9998559971b82026-01-08WarningsExact identifier
unii: 62I3C8233L
Circulation Drops 2013CIRCULATION DROPSProfessional Complementary Health Formulas377f4a5b-bcbb-47b7-b4f4-d198b98c84272026-01-08WarningsExact identifier
unii: 639KR60Q1Q
Bryonia Combination 9212BRYONIA COMBINATIONProfessional Complementary Health Formulas36f8599e-8b35-4903-9731-dbcc2fa5092e2026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: T7J046YI2B
unii: U0NQ8555JD
unii: 1W0775VX6E
Calendula Combination 9260CALENDULA COMBINATIONProfessional Complementary Health Formulas0e0770d8-680a-471a-b496-7105631ca6f42026-01-08WarningsExact identifier
unii: U0NQ8555JD
Pain Formula Drops 2046PAIN FORMULA DROPSProfessional Complementary Health Formulas4456c022-5aac-49b4-b976-b629525f3d492026-01-08WarningsExact identifier
unii: T7J046YI2B
unii: U0NQ8555JD
Chlorinated Ring Combination 9314CHLORINATED RING COMBINATIONProfessional Complementary Health Formulas2d75c97c-7b44-421a-b017-d011b3a316172026-01-08WarningsExact identifier
unii: 639KR60Q1Q
Arnica Combination 9208ARNICA COMBINATIONProfessional Complementary Health Formulas1b5fde7b-c5de-48b6-8c10-54efb54ecad32026-01-08WarningsExact identifier
unii: T7J046YI2B
unii: 1W0775VX6E
unii: S546YLW6E6
RET Liver 7008RET LIVERProfessional Complementary Health Formulasd81bdbbd-5cfa-40e3-99f5-fd5368239fbe2026-01-08WarningsExact identifier
unii: U0NQ8555JD
Geopathic Stress Drops 2096GEOPATHIC STRESS DROPSProfessional Complementary Health Formulas7d7302b8-3959-4e1e-ad1f-88d265ba9d322026-01-08WarningsExact identifier
unii: 27YLU75U4W
Nitro-Thio Combination 9318NITRO-THIO COMBINATIONProfessional Complementary Health Formulas8ef8ac5a-df80-43a7-827d-de224a19beb92026-01-08WarningsExact identifier
unii: 639KR60Q1Q
Alopecia Formula 2139ALOPECIA FORMULAProfessional Complementary Health Formulasce0eaf67-a435-4167-b9ce-c0ff1f8a9dc22026-01-08WarningsExact identifier
unii: 27YLU75U4W
Teething Drops 2120TEETHING DROPSProfessional Complementary Health Formulas31644007-d0a9-4482-a6b4-555b70686a722026-01-08WarningsExact identifier
unii: T7J046YI2B
Injury Drops 2034INJURY DROPSProfessional Complementary Health Formulas024011a0-6471-4016-86d4-19eeb21f0d822026-01-08WarningsExact identifier
unii: 27YLU75U4W
Colic Drops 2155COLIC DROPSProfessional Complementary Health Formulas17b9e92f-f4ed-48b4-ab02-8b7cba0a20272026-01-08WarningsExact identifier
unii: T7J046YI2B
Dementia Drops 2117DEMENTIA DROPSProfessional Complementary Health Formulas83aec02b-bc62-49a2-ba35-4ac94f9bfc6e2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Cough Drops 2014COUGH DROPSProfessional Complementary Health Formulas533c8124-d8bc-404a-9f1f-680d7ef8eb362026-01-08WarningsExact identifier
unii: 62I3C8233L
unii: T7J046YI2B
Anti-Inflammation Drops 2005ANTI-INFLAMMATION DROPSProfessional Complementary Health Formulas66c901e0-9489-423b-98ef-c9fc517b5bd22026-01-08WarningsExact identifier
unii: T7J046YI2B
Aesculus Combination 9202AESCULUS COMBINATIONProfessional Complementary Health Formulas5318d83a-2d8f-4ecc-80ac-d191be5f198f2026-01-08WarningsExact identifier
unii: 1W0775VX6E
Herbal Diuretic Liquescence 3011HERBAL DIURETIC LIQUESCENCEProfessional Complementary Health Formulas5eee7f21-a3c4-46e0-a642-a4ca635734e32026-01-08WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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