Pollen Mix

Product NDC
43857-0535
11-digit product format
438570535
Labeler code
43857
Product ID
43857-0535_6af21280-f2cd-40ac-adc7-52f1e10c3575
Type
HUMAN OTC DRUG
Nonproprietary name
American Elm, Plane (Sycamore), Ash, Beech, Willow, Elder (Box Elder), Alder, Cedar, Maple, Hazel, Poplar, Kentucky Bluegrass, Orchard Grass, Silver Birch, Bermuda Grass, Johnson Grass, Rye Grass, Vernal Grass, Bahia Grass, Oak, Hickory, Timothy Grass
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-10-29
Substance
ACER SACCHARUM POLLEN; ALNUS RUBRA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; BETULA PENDULA POLLEN; CARYA GLABRA POLLEN; CORYLUS AVELLANA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; FAGUS SYLVATICA POLLEN; FRAXINUS EXCELSIOR POLLEN; JUNIPERUS VIRGINIANA POLLEN; PASPALUM NOTATUM POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS X ACERIFOLIA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; QUERCUS ROBUR POLLEN; SALIX X FRAGILIS POLLEN; SAMBUCUS CANADENSIS FLOWER; SECALE CEREALE POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN
Active strength
16; 16; 16; 16; 16; 16; 16; 16; 16; 16; 16; 16; 16; 16; 16; 16; 16; 16; 16; 16; 16; 16 [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], 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], 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 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 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 · 10 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43857-0535-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43857-0535-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43857-0535-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43857-0535-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43857-0535-11332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
Pollen Mix
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ULMUS AMERICANA POLLEN16 [hp_X]/mL
PLATANUS X ACERIFOLIA POLLEN16 [hp_X]/mL
FRAXINUS EXCELSIOR POLLEN16 [hp_X]/mL
FAGUS SYLVATICA POLLEN16 [hp_X]/mL
SALIX X FRAGILIS POLLEN16 [hp_X]/mL
SAMBUCUS CANADENSIS FLOWER16 [hp_X]/mL
ALNUS RUBRA POLLEN16 [hp_X]/mL
JUNIPERUS VIRGINIANA POLLEN16 [hp_X]/mL
ACER SACCHARUM POLLEN16 [hp_X]/mL
CORYLUS AVELLANA POLLEN16 [hp_X]/mL
POPULUS ALBA POLLEN16 [hp_X]/mL
POA PRATENSIS POLLEN16 [hp_X]/mL
DACTYLIS GLOMERATA POLLEN16 [hp_X]/mL
BETULA PENDULA POLLEN16 [hp_X]/mL
CYNODON DACTYLON POLLEN16 [hp_X]/mL
SORGHUM HALEPENSE POLLEN16 [hp_X]/mL
SECALE CEREALE POLLEN16 [hp_X]/mL
ANTHOXANTHUM ODORATUM POLLEN16 [hp_X]/mL
PASPALUM NOTATUM POLLEN16 [hp_X]/mL
QUERCUS ROBUR POLLEN16 [hp_X]/mL
CARYA GLABRA POLLEN16 [hp_X]/mL
PHLEUM PRATENSE POLLEN16 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 22 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89BAT511BDInternal UNII lookup
77X11O684JInternal UNII lookup
1824QUA0U3Internal UNII lookup
63218N1ZBIInternal UNII lookup
UQ7Z2EA3ZIInternal UNII lookup
C87P971T6WInternal UNII lookup
Z0F2YK1B7HInternal UNII lookup
PY0JA16R2GInternal UNII lookup
V38QUQ7861Internal UNII lookup
CR2J49TL6LInternal UNII lookup
VU8C8SB23PInternal UNII lookup
SCB8J7LS3TInternal UNII lookup
83N78IDA7PInternal UNII lookup
ZL5TV40C5YInternal UNII lookup
175F461W10Internal UNII lookup
577VA5B4HPInternal UNII lookup
I6KAZ8AO1OInternal UNII lookup
2KIK19R45YInternal UNII lookup
V003SHB7VKInternal UNII lookup
4PNW66TTHRInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8b9fa995-47a4-4b2d-9db8-5f4c6eccbd16Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-10-17DRUG FACTS:
2023-01-30DRUG FACTS:
2021-11-19DRUG FACTS:
2021-01-29DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0535-1Pollen Mix30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0535POLLEN MIX (AMERICAN ELM, PLANE (SYCAMORE), ASH, BEECH, WILLOW, ELDER (BOX ELDER), ALDER, CEDAR, MAPLE, HAZEL, POPLAR, KENTUCKY BLUEGRASS, ORCHARD GRASS, SILVER BIRCH, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, OAK, HICKORY, TIMOTHY GRASS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20241019_8b9fa995-47a4-4b2d-9db8-5f4c6eccbd16.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
Pollen MixAMERICAN ELM, PLANE (SYCAMORE), ASH, BEECH, WILLOW, ELDER (BOX ELDER), ALDER, CEDAR, MAPLE, HAZEL, POPLAR, KENTUCKY BLUEGRASS, ORCHARD GRASS, SILVER BIRCH, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, OAK, HICKORY, TIMOTHY GRASSBioActive Nutritional, Inc.8b9fa995-47a4-4b2d-9db8-5f4c6eccbd162024-10-17WarningsExact identifier
ndc (product): 43857-0535

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0535-14385705350130 mL in 1 BOTTLE, DROPPER (43857-0535-1) 30 ml2019-10-290000-00-00NoNoCurrent