FDA.reportPublic FDA data

Flu Formula

Product NDC
83027-0090
11-digit product format
830270090
Labeler code
83027
Product ID
83027-0090_47b95d16-55f7-49cc-834e-d1bd9051c315
Type
HUMAN OTC DRUG
Nonproprietary name
Apis Mellifica, Aconitum Napellus, Allium Cepa, Bryonia (Alba), Eupatorium Perfoliatum, Euphrasia Officinalis, Ipecacuanha, Belladonna, Echinacea Purpurea, Asclepias Vincetoxicum, Gelsemium Sempervirens, Phosphorus, Influenzinum
Dosage form
SPRAY
Route
ORAL
Labeler
Nutritional Specialties, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-06-27
Substance
APIS MELLIFERA; ACONITUM NAPELLUS WHOLE; ONION; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; IPECAC; ATROPA BELLADONNA; ECHINACEA PURPUREA WHOLE; VINCETOXICUM HIRUNDINARIA ROOT; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORUS; INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)
Active strength
6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Flu Formula
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIS MELLIFERA6 [hp_X]/mL
ACONITUM NAPELLUS WHOLE6 [hp_X]/mL
ONION6 [hp_X]/mL
BRYONIA ALBA ROOT6 [hp_X]/mL
EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]/mL
EUPHRASIA STRICTA6 [hp_X]/mL
IPECAC6 [hp_X]/mL
ATROPA BELLADONNA6 [hp_X]/mL
ECHINACEA PURPUREA WHOLE6 [hp_X]/mL
VINCETOXICUM HIRUNDINARIA ROOT10 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED)12 [hp_X]/mL
INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED)12 [hp_X]/mL
INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)12 [hp_X]/mL
INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7S82P3R43ZInternal UNII lookup
U0NQ8555JDInternal UNII lookup
492225Q21HInternal UNII lookup
T7J046YI2BInternal UNII lookup
1W0775VX6EInternal UNII lookup
C9642I91WLInternal UNII lookup
62I3C8233LInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
QI7G114Y98Internal UNII lookup
9R858U917WInternal UNII lookup
639KR60Q1QInternal UNII lookup
27YLU75U4WInternal UNII lookup
34C49NV47PInternal UNII lookup
P483J7GX6DInternal UNII lookup
TBV2PPG6EFInternal UNII lookup
H2198F8ZNAInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
811d21d9-d7b7-44d5-885b-7bfb49cd069bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0090-1Flu Formula60 mL in 1 BOTTLE, DROPPERSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0090FLU FORMULA (APIS MELLIFICA, ACONITUM NAPELLUS, ALLIUM CEPA, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, EUPHRASIA OFFICINALIS, IPECACUANHA, BELLADONNA, ECHINACEA PURPUREA, ASCLEPIAS VINCETOXICUM, GELSEMIUM SEMPERVIRENS, PHOSPHORUS, INFLUENZINUM) SPRAY [NUTRITIONAL SPECIALTIES, INC.]1Current NDC, 1 package rows20230707_811d21d9-d7b7-44d5-885b-7bfb49cd069b.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flu FormulaAPIS MELLIFICA, ACONITUM NAPELLUS, ALLIUM CEPA, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, EUPHRASIA OFFICINALIS, IPECACUANHA, BELLADONNA, ECHINACEA PURPUREA, ASCLEPIAS VINCETOXICUM, GELSEMIUM SEMPERVIRENS, PHOSPHORUS, INFLUENZINUMNutritional Specialties, Inc.811d21d9-d7b7-44d5-885b-7bfb49cd069b2023-06-27WarningsExact identifier
ndc (product): 83027-0090

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83027-0090-18302700900160 mL in 1 BOTTLE, DROPPER (83027-0090-1) 60 ml2023-06-27NoNoCurrent