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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV38QUQ7861, Z0F2YK1B7H, 2KIK19R45Y, ZL5TV40C5Y, KPO1Z9N98A, CR2J49TL6L, 175F461W10, 83N78IDA7P, 63218N1ZBI, 1824QUA0U3, PY0JA16R2G, V003SHB7VK, 65M88RW2EG, 77X11O684J, SCB8J7LS3T, VU8C8SB23P, 4PNW66TTHR, UQ7Z2EA3ZI, C87P971T6W, I6KAZ8AO1O

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0535-12024-10-17C16284748780-1ba0f9c33-47e2-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0535-12023-01-30C16284748780-1ba0f9c33-47e2-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0535-12021-11-19C16284748780-1ba0f9c33-47e2-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0535-12021-01-29C16284748780-1ba0f9c33-47e2-a910-e053-dadaa90a0b85DRUG 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

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