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 154 of 244 · 4,862 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a146e6b-95f0-22e0-e053-2a95a90a6b142025-01-09Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a025521-edd7-e09e-e053-2995a90ac89c2025-01-09Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a02ba6f-6bba-7543-e053-2a95a90afa0d2025-01-09Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a024809-986e-2f26-e053-2a95a90a6c6f2025-01-09Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a028651-1d50-4076-e053-2a95a90a29e52025-01-09Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a032a72-eceb-204d-e053-2a95a90a670d2025-01-09Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a035784-4144-2788-e053-2a95a90ab6182025-01-09Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a146e6b-95ca-22e0-e053-2a95a90a6b142025-01-09Exact identifier
unii: U0NQ8555JD
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr Tichenors First Aid AntisepticALCOHOLDr. G. H. Tichenor's Antiseptic Company9947855d-b8e0-4c22-a627-16b526242e392025-01-09WarningsExact identifier
unii: 3K9958V90M
AM-14SILVER, CALCIUM IODIDE, LYTTA VESICATORIA, COPPER, FERROUS IODIDE, GOLDENSEAL, IODINE, DAPHNE MEZEREUM BARK, PHOSPHORIC ACID, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAF, AND RUMEX CRISPUS WHOLEDNA Labs, Inc.8bf2fde6-fd71-47f8-b5ec-c5e34857ab642025-01-09WarningsExact identifier
unii: 27YLU75U4W
N-5PHOSPHORUS, TRIBASIC CALCIUM PHOSPHATE, FERROSOFERRIC PHOSPHATE, ACTIVATED CHARCOAL, TIN, AND BEEF LUNGDNA Labs, Inc.ac1d88f5-ac42-40b1-a509-83fbd1d68e782025-01-09WarningsExact identifier
unii: 27YLU75U4W
N-4CHELIDONIUM MAJUS, BRYONIA ALBA ROOT, STRYCHNOS NUX-VOMICA SEED, LYCOPODIUM CLAVATUM WHOLE, MAMMAL LIVER, SODIUM SULFATE, AND MILK THISTLEDNA Labs, Inc.4e3f6d49-f11d-439b-b94a-211e4b084b5e2025-01-09WarningsExact identifier
unii: T7J046YI2B
N-9PHOSPHORUS, CITRULLUS COLOCYNTHIS FRUIT PULP, IRIS VERSICOLOR WHOLE, LYCOPODIUM CLAVATUM WHOLE, MOMORDICA BALSAMINA WHOLE, AND BOS TAURUS PANCREASDNA Labs, Inc.0a673ac2-4bab-4b24-9007-835b68cd3e6b2025-01-09WarningsExact identifier
unii: 27YLU75U4W
N-11CINCHONA OFFICINALIS BARK, PHOSPHORIC ACID, ANEMONE PULSATILLA, PHOSPHORUS, PICRIC ACID, DIBASIC POTASSIUM PHOSPHATE, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS ADRENAL GLAND, SUS SCROFA TESTICLE, AND BOS TAURUS PROSTATE GLANDDNA Labs, Inc.74b694d7-448d-4509-8bc5-fb1eadca9b252025-01-09WarningsExact identifier
unii: 27YLU75U4W
N-12PHOSPHORIC ACID, CINCHONA OFFICINALIS BARK, ANEMONE PULSATILLA, PHOSPHORUS, PICRIC ACID, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, VIBURNUM OPULUS WHOLE, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS OVARY, BOS TAURUS ADRENAL GLAND, AND THYROID, UNSPECIFIEDDNA Labs, Inc.89ed00b4-5739-439e-bae9-e00b0b0d72222025-01-09WarningsExact identifier
unii: 27YLU75U4W
N-23ANEMONE PULSATILLA, PHOSPHORUS, SILICON DIOXIDE, NITRIC ACID, ARSENIC TRIOXIDE, TOXICODENDRON PUBESCENS WHOLE, AND BOS TAURUS HYPOTHALAMUSDNA Labs, Inc.b6365b49-06fb-4692-96f7-a5097b70bc912025-01-09WarningsExact identifier
unii: 27YLU75U4W
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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