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 119 of 244 · 4,877 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aconitum napellusACONITUM NAPELLUSBoiron84b1d915-97a1-4535-e053-2a91aa0aa4642025-09-10Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSBoiron84b29e49-ea6a-8519-e053-2991aa0a7cd12025-09-10Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSBoiron840eea30-7779-d232-e053-2a91aa0ac5962025-09-10Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSBoiron8860ffcb-a889-4deb-e053-2995a90ac0802025-09-10Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSBoiron840f0eec-a05a-7c6e-e053-2991aa0aa6c62025-09-10Exact identifier
unii: U0NQ8555JD
AshleyBelle Moisturizing Hand Sanitizer Dragon FruitETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e7d57b2-04ab-2ffe-e063-6394a90af8322025-09-10WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Jasmine ShadeETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e7df19c-00aa-5f1d-e063-6294a90af15e2025-09-10WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Mango PapayaETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e7e9c95-791c-7b2e-e063-6294a90ac3652025-09-10WarningsExact identifier
unii: 3K9958V90M
Cold Flu Relief BerryCOLD FLU RELIEF BERRYSchwabe North America03241f9f-8188-48ed-9177-42ef1e6c0fd62025-09-10WarningsExact identifier
unii: 27YLU75U4W
unii: 639KR60Q1Q
unii: 62I3C8233L
unii: T7J046YI2B
unii: U0NQ8555JD
unii: 1W0775VX6E
unii: S546YLW6E6
Smart Care SQUISHMALLOWS SWEET PEA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.777d9863-5789-47ff-a1e6-1c259b580bae2025-09-10WarningsExact identifier
unii: 3K9958V90M
Smart Care Barbie HAND SANITIZERETHYL ALCOHOLAshtel Studios, Incf6522ee1-f791-44d9-9e87-70411ab1cefa2025-09-09WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLUnifirst First Aid Corporation5c303611-f2d6-417b-b269-bb0013398efb2025-09-09WarningsExact identifier
unii: 3K9958V90M
McKesson Antiseptic Hand SanitizerETHYL ALCOHOLMcKesson Medical-Surgicalcc95bae9-d8ef-41f8-e053-2995a90aadab2025-09-09WarningsExact identifier
unii: 3K9958V90M
ECOLAB Hand SanitizerETHYL ALCOHOL 66.5%ECOLAB Food Safety Specialties, Inc.4c430aff-7f88-5529-e054-00144ff8d46c2025-09-09WarningsExact identifier
unii: 3K9958V90M
Gel Antiseptic Hand WashGEL ANTISEPTIC HAND WASHMetalloid Corporation3e6381cc-6b2d-303d-e063-6394a90ae2c62025-09-09WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Champagne AppleETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6ad099-c770-064f-e063-6294a90a222d2025-09-09WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Vanilla CascadeETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6aef24-f162-5549-e063-6294a90a30b82025-09-09WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Caramel CinnamonETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6aef38-215c-defa-e063-6394a90a46a62025-09-09WarningsExact identifier
unii: 3K9958V90M
Oasis TEARS PF PLUS Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.5d080191-423d-4c0a-b5ae-2ccf5c4a67cb2025-09-08WarningsExact identifier
unii: PDC6A3C0OX
Smart Care Kids Hand Sanitizer CrayolaALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e44c28e-c6ed-52b4-e063-6394a90a9dd02025-09-08WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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