Hayfever Tonic

Product NDC
43857-0611
Requested package NDC
43857-0611-1
11-digit product format
438570611
Labeler code
43857
Product ID
43857-0611_4eff43ec-5032-4ce5-bcbb-ad01b10ea6c2
Type
HUMAN OTC DRUG
Nonproprietary name
Echinacea Purpurea, Hydrastis Canadensis, Eupatorium Perfoliatum, Verbascum Thapsus, Ailanthus Glandulosus, Allium Cepa, Ambrosia Artemisiaefolia, Aurum Muriaticum, Camphora, Ipecacuanha, Kali Bichromicum, Solidago Virgaurea, Kentucky Bluegrass, Orchard Grass, Bermuda Grass, Johnson Grass, Rye Grass, Vernal Grass, Bahia Grass, Timothy Grass, American Elm, Plane (Sycamore), Ash, Beech, Willow, Elder (Box Elder), Alder, Cedar, Maple, Hazel, Poplar, Silver Birch, Oak, Hickory
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-08-03
Substance
ACER NEGUNDO POLLEN; ACER SACCHARUM POLLEN; AILANTHUS ALTISSIMA FLOWERING TWIG; ALNUS RUBRA POLLEN; AMBROSIA ARTEMISIIFOLIA WHOLE; ANTHOXANTHUM ODORATUM; BETULA PENDULA POLLEN; CAMPHOR (NATURAL); CARYA GLABRA POLLEN; CORYLUS AVELLANA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; ECHINACEA PURPUREA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; FAGUS SYLVATICA POLLEN; FRAXINUS EXCELSIOR POLLEN; GOLD TRICHLORIDE; GOLDENSEAL; IPECAC; JUNIPERUS VIRGINIANA POLLEN; LOLIUM PERENNE POLLEN; ONION; PASPALUM NOTATUM POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS X ACERIFOLIA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POTASSIUM DICHROMATE; QUERCUS ROBUR POLLEN; SALIX X FRAGILIS POLLEN; SOLIDAGO VIRGAUREA FLOWERING TOP; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; VERBASCUM THAPSUS WHOLE
Active strength
16; 16; 12; 16; 12; 16; 16; 12; 16; 16; 16; 16; 1; 6; 16; 16; 12; 5; 12; 16; 16; 12; 16; 16; 16; 16; 16; 12; 16; 16; 12; 16; 16; 8 [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; [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; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized ...
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
Hayfever Tonic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ECHINACEA PURPUREA WHOLE16 [hp_X]/mL
GOLDENSEAL16 [hp_X]/mL
EUPATORIUM PERFOLIATUM FLOWERING TOP12 [hp_X]/mL
VERBASCUM THAPSUS WHOLE16 [hp_X]/mL
AILANTHUS ALTISSIMA FLOWERING TWIG12 [hp_X]/mL
ONION16 [hp_X]/mL
AMBROSIA ARTEMISIIFOLIA WHOLE16 [hp_X]/mL
GOLD TRICHLORIDE12 [hp_X]/mL
CAMPHOR (NATURAL)16 [hp_X]/mL
IPECAC16 [hp_X]/mL
POTASSIUM DICHROMATE16 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP16 [hp_X]/mL
POA PRATENSIS POLLEN1 [hp_X]/mL
DACTYLIS GLOMERATA POLLEN6 [hp_X]/mL
CYNODON DACTYLON POLLEN16 [hp_X]/mL
SORGHUM HALEPENSE POLLEN16 [hp_X]/mL
LOLIUM PERENNE POLLEN12 [hp_X]/mL
ANTHOXANTHUM ODORATUM5 [hp_X]/mL
PASPALUM NOTATUM POLLEN12 [hp_X]/mL
PHLEUM PRATENSE POLLEN16 [hp_X]/mL
ULMUS AMERICANA POLLEN16 [hp_X]/mL
PLATANUS X ACERIFOLIA POLLEN12 [hp_X]/mL
FRAXINUS EXCELSIOR POLLEN16 [hp_X]/mL
FAGUS SYLVATICA POLLEN16 [hp_X]/mL
SALIX X FRAGILIS POLLEN16 [hp_X]/mL
ACER NEGUNDO POLLEN16 [hp_X]/mL
ALNUS RUBRA POLLEN16 [hp_X]/mL
JUNIPERUS VIRGINIANA POLLEN12 [hp_X]/mL
ACER SACCHARUM POLLEN16 [hp_X]/mL
CORYLUS AVELLANA POLLEN16 [hp_X]/mL
POPULUS ALBA POLLEN12 [hp_X]/mL
BETULA PENDULA POLLEN16 [hp_X]/mL
QUERCUS ROBUR POLLEN16 [hp_X]/mL
CARYA GLABRA POLLEN8 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 34 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QI7G114Y98Internal UNII lookup
ZW3Z11D0JVInternal UNII lookup
1W0775VX6EInternal UNII lookup
C9TD27U172Internal UNII lookup
8P29O5P7XUInternal UNII lookup
492225Q21HInternal UNII lookup
9W34L2CQ9AInternal UNII lookup
15443PR153Internal UNII lookup
N20HL7Q941Internal UNII lookup
62I3C8233LInternal UNII lookup
T4423S18FMInternal UNII lookup
5405K23S50Internal UNII lookup
SCB8J7LS3TInternal UNII lookup
83N78IDA7PInternal UNII lookup
175F461W10Internal UNII lookup
577VA5B4HPInternal UNII lookup
4T81LB52R0Internal UNII lookup
YMW1K70E4QInternal UNII lookup
V003SHB7VKInternal UNII lookup
65M88RW2EGInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f4395bb7-c186-4e4f-a7cd-a7f3db46091aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0611-12024-10-17C16284748780-1f386c649-b525-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0611-12023-01-30C16284748780-1f386c649-b525-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0611-1Hayfever Tonic60 mL in 1 BOTTLE, DROPPERLIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0611HAYFEVER TONIC (ECHINACEA PURPUREA, HYDRASTIS CANADENSIS, EUPATORIUM PERFOLIATUM, VERBASCUM THAPSUS, AILANTHUS GLANDULOSUS, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, AURUM MURIATICUM, CAMPHORA, IPECACUANHA, KALI BICHROMICUM, SOLIDAGO VIRGAUREA, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, AMERICAN ELM, PLANE (SYCAMORE), ASH, BEECH, WILLOW, ELDER (BOX ELDER), ALDER, CEDAR, MAPLE, HAZEL, POPLAR, SILVER BIRCH, OAK, HICKORY) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20241019_f4395bb7-c186-4e4f-a7cd-a7f3db46091a.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
Hayfever TonicECHINACEA PURPUREA, HYDRASTIS CANADENSIS, EUPATORIUM PERFOLIATUM, VERBASCUM THAPSUS, AILANTHUS GLANDULOSUS, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, AURUM MURIATICUM, CAMPHORA, IPECACUANHA, KALI BICHROMICUM, SOLIDAGO VIRGAUREA, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, AMERICAN ELM, PLANE (SYCAMORE), ASH, BEECH, WILLOW, ELDER (BOX ELDER), ALDER, CEDAR, MAPLE, HAZEL, POPLAR, SILVER BIRCH, OAK, HICKORYBioActive Nutritional, Inc.f4395bb7-c186-4e4f-a7cd-a7f3db46091a2024-10-17WarningsExact identifier
ndc (package): 43857-0611-1
ndc (product): 43857-0611
ndc11 (package): 43857061101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0611-14385706110160 mL in 1 BOTTLE, DROPPER (43857-0611-1) 60 ml2021-08-030000-00-00NoNoCurrent