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 90 of 246 · 4,918 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcare Antiseptic HandrubALCOHOLSC Johnson Professional USA, Inc.26afc6c3-125e-4937-9747-a619105af1ad2025-12-22WarningsExact identifier
unii: 3K9958V90M
Cold and Flu ReliefALLIUM CEPA, ANTIMON TART, ARNICA, BAPTISIA, EUPATORIUM PERF, GELSEMIUM, KALI BIC, LACHESIS, MER IOD RUB, STICTA , SULPHUR IOD, URTICA UREight and Company L.L.C9c5fa3e0-3e99-4fe0-86b9-f4d8de230a982025-12-22WarningsExact identifier
unii: 639KR60Q1Q
unii: 1W0775VX6E
Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEKC Pharmaceuticals, Inc4682f68d-6bdd-d860-e063-6394a90a2b522025-12-21WarningsExact identifier
unii: PDC6A3C0OX
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINWalmart443e214b-2680-79a9-e063-6294a90a68ba2025-12-20WarningsExact identifier
unii: PDC6A3C0OX
Equate Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEWalmart44155cf8-6fd9-d16f-e063-6394a90ac7312025-12-20WarningsExact identifier
unii: PDC6A3C0OX
Alcohol sanitizer wipesALCOHOL/PURIFIED WATERSHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD.ab9634bd-4226-2f73-e053-2995a90a802f2025-12-19WarningsExact identifier
unii: 3K9958V90M
COUGH BABYIPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, AND RUMEX CRISPUS ROOTHyland's Inc.2daac16d-69d0-48bf-806f-f22c0a6973ad2025-12-19WarningsExact identifier
unii: 27YLU75U4W
unii: 62I3C8233L
unii: T7J046YI2B
Kids Cold and Cough DaytimeCALCIUM SULFIDE,GOLDENSEAL,ONION,PHOSPHORUS,PULSATILLA VULGARIS, SODIUM CHLORIDEHyland's Consumer Health Inc.e6118c79-b6d5-5c09-e053-2a95a90a30cf2025-12-19WarningsExact identifier
unii: 27YLU75U4W
4 KIDS COLD N COUGH GRAPE FLAVORONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, AND SULFURHyland's Inc.798e2a4d-da2d-4bbd-a9b8-574490ef73572025-12-19WarningsExact identifier
unii: 27YLU75U4W
4 Kids Cold and Cough DaytimeONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALHyland's Inc.804e0e7a-20eb-128b-e053-2991aa0aa82c2025-12-19WarningsExact identifier
unii: 27YLU75U4W
4 Kids Cold and Cough Nighttime Natural Grape FlavorONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEANHyland's Inc.7923e59a-f62c-44df-e053-2991aa0afc1e2025-12-19WarningsExact identifier
unii: 27YLU75U4W
PURELL Healthcare Advanced Hand Sanitizer Gentle and Free FoamALCOHOLGOJO Industries, Inc.74a190b2-6ba6-4cd3-99fb-0a4450eb3f372025-12-19WarningsExact identifier
unii: 3K9958V90M
Naughty Kitty KatNO GAG DEEP THROAT SPRAYINKED SUGAR, INC170eb644-c72c-5744-e063-6394a90a767d2025-12-19WarningsExact identifier
unii: PDC6A3C0OX
PURELL Professional Advanced Hand Sanitizer Fragrance Free GelALCOHOLGOJO Industries, Inc.4952bb21-fefa-4ae1-8e1a-feb412ce100c2025-12-19WarningsExact identifier
unii: 3K9958V90M
Artificial TearsGLYCERINGeri-Care Pharmaceuticals, Corp7cc437e3-bad9-59be-e053-2991aa0a1da32025-12-19WarningsExact identifier
unii: PDC6A3C0OX
Signature Care Eye Drops Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEBetter Living Brands LLC901f3bbe-e1bb-4e44-879c-711e59813a7f2025-12-19WarningsExact identifier
unii: PDC6A3C0OX
AllergEaseALLIUM CEPA, APIS MELLIFICA, ARALIA RAC, ARUNDO, BAPTISIA, ECHINACEA, EUPHRASIA, GELSEMIUM, HISTAMINUM, LYCOPODIUM, RHUS TOX, SABADILLA, SANGUINARIA, URTICA UR.Eight and Company L.L.Cec4fae96-ffe3-489c-9ed2-4aaec114c4932025-12-18WarningsExact identifier
unii: 639KR60Q1Q
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PSSI E-SanALCOHOLSafe Foods Chemical Innovationsb688591a-8eea-f1ac-e053-2995a90aabac2025-12-18WarningsExact identifier
unii: 3K9958V90M
No-Shift-LagARNICA MONTANA, BELLIS PERENNIS, IPECAC, PHYTOLACCA AMERICANA ROOT, AND ZINCMiers Laboratories704cb13c-3a14-49bc-b636-552d9ceddbdb2025-12-18WarningsExact identifier
unii: 62I3C8233L

Reported adverse events (FAERS/openFDA)#

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