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 79 of 249 · 4,965 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bridged Ring Combination 9311BRIDGED RING COMBINATIONProfessional Complementary Health Formulasb4033f70-d974-493d-8ded-eaa3240bdac52026-01-08WarningsExact identifier
unii: 639KR60Q1Q
Eupatorium perfoliatum 7118EUPATORIUM PERFOLIATUMProfessional Complementary Health Formulas8689017a-c21a-4b0b-9c13-9c5cde4a91482026-01-08WarningsExact identifier
unii: 1W0775VX6E
Nausea/Morning Sickness Drops 2079NAUSEA/MORNING SICKNESS DROPSProfessional Complementary Health Formulasfd4f2738-9bdc-4fa0-bd61-c69ea4f1cf0f2026-01-08WarningsExact identifier
unii: 62I3C8233L
Crataegus Combination 9220CRATAEGUS COMBINATIONProfessional Complementary Health Formulasad44d561-9004-43f1-8271-ef52b715fa662026-01-08WarningsExact identifier
unii: 639KR60Q1Q
Bryonia 7108BRYONIAProfessional Complementary Health Formulasac34fb4b-54f3-460a-b907-fd89db68235b2026-01-08WarningsExact identifier
unii: T7J046YI2B
Echinacea Combination 9222ECHINACEA COMBINATIONProfessional Complementary Health Formulas430cc9f6-5565-4345-ac5f-d948fb3b14bd2026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 639KR60Q1Q
unii: T7J046YI2B
unii: U0NQ8555JD
unii: 1W0775VX6E
RET Heart 7009RET HEARTProfessional Complementary Health Formulase2bf8331-1c50-4216-93a4-1d3cf64047592026-01-08WarningsExact identifier
unii: U0NQ8555JD
Angina Drops 2083ANGINA DROPSProfessional Complementary Health Formulas99516597-9f59-4123-bd35-a4a73dd54d2d2026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 639KR60Q1Q
Travel Sickness Drops 2075TRAVEL SICKNESS DROPSProfessional Complementary Health Formulas8c9d93bc-a055-458a-8cc0-c984b4b754c02026-01-08WarningsExact identifier
unii: 62I3C8233L
Magnesium Combination 9232MAGNESIUM COMBINATIONProfessional Complementary Health Formulas4d99b3ec-724f-4385-ae5e-83389bb0c8fe2026-01-08WarningsExact identifier
unii: 639KR60Q1Q
unii: U0NQ8555JD
Terebinthina Combination 9248TEREBINTHINA COMBINATIONProfessional Complementary Health Formulas1363fff1-3b37-47d8-a17b-8bf8e72f66162026-01-08WarningsExact identifier
unii: 27YLU75U4W
Rheum Combination 9240RHEUM COMBINATIONProfessional Complementary Health Formulasf65a41b7-5931-4c62-89a3-7b255757527f2026-01-08WarningsExact identifier
unii: T7J046YI2B
Libido Stim Liquescence 3014LIBIDO STIM LIQUESCENCEProfessional Complementary Health Formulas3d59b77d-817b-4021-a6dd-75d3b4b608662026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Simple Chlorinated Combination 9315SIMPLE CHLORINATED COMBINATIONProfessional Complementary Health Formulasc1ab9a34-8a22-4840-ab8b-ef666dca155a2026-01-08WarningsExact identifier
unii: 639KR60Q1Q
Large Joint Pain Drops 2037LARGE JOINT PAIN DROPSProfessional Complementary Health Formulasb34b0fce-9b7a-4f64-b557-b9c0ad61187c2026-01-08WarningsExact identifier
unii: T7J046YI2B
Food Poisoning Detox 6023FOOD POISONING DETOXProfessional Complementary Health Formulas76eff6d5-a8dc-4b06-91b7-fa0f1657df1a2026-01-08WarningsExact identifier
unii: U0NQ8555JD
Dysfunctional Bleeding Drops 2138DYSFUNCTIONAL BLEEDING DROPSProfessional Complementary Health Formulas3e674c1e-c64b-416d-962f-c03493e800852026-01-08WarningsExact identifier
unii: 639KR60Q1Q
Sulphur Combination 9247SULPHUR COMBINATIONProfessional Complementary Health Formulasc9783fb0-399c-4f41-8c26-6f2d6534d3ef2026-01-08WarningsExact identifier
unii: T7J046YI2B
Nux Vomica Combination 9235NUX VOMICA COMBINATIONProfessional Complementary Health Formulas28f6663d-0a00-4650-a84e-b625024687d32026-01-08WarningsExact identifier
unii: T7J046YI2B
Low Back Pain Drops 2041LOW BACK PAIN DROPSProfessional Complementary Health Formulasc9b3e606-5991-4ce4-9e0d-51bcb44da5832026-01-08WarningsExact identifier
unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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