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 134 of 244 · 4,877 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mt Royal Hand Sanitizer70% ETHYL ALCOHOL GELMount Royal Soaps, LLCa25f5362-b868-5f47-e053-2995a90a05a72025-05-01WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd36a703b9-bcec-55ab-e063-6294a90af7822025-05-01WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd36a73f9f-faa2-89d5-e063-6294a90a4e0c2025-05-01WarningsExact identifier
unii: 3K9958V90M
Sterillium MedALCOHOLBODE Chemie GmbH8d80d5fd-7869-c551-e053-2995a90af2a92025-04-30WarningsExact identifier
unii: 3K9958V90M
Sterillium ComfortALCOHOLBODE Chemie GmbH8efc9f4e-3b20-60ba-e053-2995a90af8b12025-04-30WarningsExact identifier
unii: 3K9958V90M
Magnesium sulf. BryoniaMAGNESIUM SULF. BRYONIAUriel Pharmacy Inc.9418bb05-afd1-fc80-e053-2a95a90a33a22025-04-30WarningsExact identifier
unii: T7J046YI2B
Ear RingALLIUM CEPA, ARGENTUM NITRICUM, ASARUM CANADENSE, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, CARTILAGO SUIS, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CYCLAMEN EUROPAEUM, DULCAMARA, GINKGO BILOBA, GRAPHITES, KREOSOTUM, MUCOSA NASALIS SUIS, NATRUM SALICYLICUM, PHOSPHORUS, PLUMBUM METALLICUM, THERIDION, ZINCUM METALLICUMDeseret Biologicals, Inc.c4b66b0a-fb00-4047-af7e-b5b0f2327f2f2025-04-29WarningsExact identifier
unii: 27YLU75U4W
FRESH FEELS HAND SANITIZER MIST BLUE RASPBERRY SCENTETHYL ALCOHOLPearl World Inc.106955cd-4485-4a0b-87a2-d4343e6a89f62025-04-29WarningsExact identifier
unii: 3K9958V90M
ThroatSprayECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMEnergique, Inc.125ffbf4-681e-451c-a96d-0b64166194742025-04-29WarningsExact identifier
unii: PDC6A3C0OX
FRESH FEELS HAND SANITIZER MIST GUMMY BEAR SCENTETHYL ALCOHOLPearl World Inc.f8e02860-0e21-4e5c-b2fc-1340d145afe02025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BUBBLE TEA SCENTETHYL ALCOHOLPearl World Inc.f0fbe51f-3402-42a1-8364-8e3f2e35ee662025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST MANGO SCENTETHYL ALCOHOLPearl World Inc.33123052-f8e6-433d-9734-05e21ecc0e622025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PEAR SPLASH SCENTETHYL ALCOHOLPearl World Inc.20f9d364-9386-4d60-9c60-13c5819588602025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST CHERRY SCENTETHYL ALCOHOLPearl World Inc.6e2c5527-b18a-46af-91b9-e9aa7d1498362025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST OCEAN BREEZE SCENTETHYL ALCOHOLPearl World Inc.00a0af9f-76ce-440d-b25e-2bb40c88fd1d2025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST SWEET PEONY SCENTETHYL ALCOHOLPearl World Inc.aeca3043-7f90-43e8-9890-d20a9727b95b2025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST VANILLA SUGAR SCENTETHYL ALCOHOLPearl World Inc.740d4fd7-c4c3-448b-ad1e-6227b9f2d5252025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COCONUT LIME SCENTETHYL ALCOHOLPearl World Inc.9ef8a421-633a-4615-ae1d-dbd2568d947b2025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST STRAWBERRY SCENTETHYL ALCOHOLPearl World Inc.673ea52e-0033-4831-8656-7392cf7b7c712025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PEACH SCENTETHYL ALCOHOLPearl World Inc.7b263fac-38b4-4bdf-9ac3-419ddb2fc37a2025-04-29WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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