Dosage and administration
10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
Pollen Mix
- Manufacturer
- BioActive Nutritional, Inc. | Apotheca Company
- Effective date
- 2024-10-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:28:15
Label at a glance#
ProductPollen Mix
Active ingredientULMUS AMERICANA POLLEN, PLATANUS X ACERIFOLIA POLLEN, FRAXINUS EXCELSIOR POLLEN, FAGUS SYLVATICA POLLEN, SALIX X FRAGILIS POLLEN, SAMBUCUS CANADENSIS FLOWER, ALNUS RUBRA POLLEN, JUNIPERUS VIRGINIANA POLLEN, ACER SACCHARUM POLLEN, CORYLUS AVELLANA POLLEN, POPULUS ALBA POLLEN, POA PRATENSIS POLLEN, DACTYLIS GLOMERATA POLLEN, BETULA PENDULA POLLEN, CYNODON DACTYLON POLLEN, SORGHUM HALEPENSE POLLEN, SECALE CEREALE POLLEN, ANTHOXANTHUM ODORATUM POLLEN, PASPALUM NOTATUM POLLEN, QUERCUS ROBUR POLLEN, CARYA GLABRA POLLEN, PHLEUM PRATENSE POLLEN
Label structure9 sections
Label contents#
Full prescribing information#
ACTIVE INGREDIENTS:
American Elm 16X, 24X, 30X, Plane (Sycamore) 16X, 24X, 30X, Ash 16X, 24X, 30X, Beech 16X, 24X, 30X, Willow 16X, 24X, 30X, Elder (Box Elder) 16X, 24X, 30X, Alder 16X, 24X, 30X, Cedar 16X, 24X, 30X, Maple 16X, 24X, 30X, Hazel 16X, 24X, 30X, Poplar 16X, 24X, 30X, Kentucky Bluegrass 16X, 24X, 30X, Orchard Grass 16X, 24X, 30X, Silver Birch 16X, 24X, 30X, Bermuda Grass 16X, 24X, 30X, Johnson Grass 16X, 24X, 30X, Rye Grass 16X, 24X, 30X, Vernal Grass 16X, 24X, 30X, Bahia Grass 16X, 24X, 30X, Oak 16X, 24X, 30X, Hickory 16X, 24X, 30X, Timothy Grass 16X, 24X, 30X.
INDICATIONS:
For temporary relief of allergies due to pollen.
WARNINGS:
If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is broken or missing.
Store in cool, dry place.
KEEP OUT OF REACH OF CHILDREN:
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DIRECTIONS:
10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
INDICATIONS:
For temporary relief of allergies due to pollen.
INACTIVE INGREDIENTS:
Demineralized Water, 25% Ethanol
QUESTIONS:
Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com
PACKAGE LABEL DISPLAY:
BIOActive Nutritional
POLLEN MIX
HOMEOPATHIC
1 FL OZ (30 ml)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43857-0535-1 | 2024-10-17 | C162847 | 48780-1 | ba0f9c33-47e2-a910-e053-dadaa90a0b85 | DRUG FACTS: |
| 43857-0535-1 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-47e2-a910-e053-dadaa90a0b85 | DRUG FACTS: |
| 43857-0535-1 | 2021-11-19 | C162847 | 48780-1 | ba0f9c33-47e2-a910-e053-dadaa90a0b85 | DRUG FACTS: |
| 43857-0535-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-47e2-a910-e053-dadaa90a0b85 | DRUG FACTS: |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43857-0535-1 | Pollen Mix | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43857-0535 | POLLEN 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.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241019_8b9fa995-47a4-4b2d-9db8-5f4c6eccbd16.zip |
Products#
Every source-derived product name is available through these pages.
- Pollen 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
- ULMUS AMERICANA POLLEN
- PLATANUS X ACERIFOLIA POLLEN
- FRAXINUS EXCELSIOR POLLEN
- FAGUS SYLVATICA POLLEN
- SALIX X FRAGILIS POLLEN
- SAMBUCUS CANADENSIS FLOWER
- ALNUS RUBRA POLLEN
- JUNIPERUS VIRGINIANA POLLEN
- ACER SACCHARUM POLLEN
- CORYLUS AVELLANA POLLEN
- POPULUS ALBA POLLEN
- POA PRATENSIS POLLEN
- DACTYLIS GLOMERATA POLLEN
- BETULA PENDULA POLLEN
- CYNODON DACTYLON POLLEN
- CYNODON DACTYLON WHOLE
- SORGHUM HALEPENSE POLLEN
- SECALE CEREALE POLLEN
- ANTHOXANTHUM ODORATUM POLLEN
- PASPALUM NOTATUM POLLEN
- QUERCUS ROBUR POLLEN
- CARYA GLABRA POLLEN
- PHLEUM PRATENSE POLLEN
- PHLEUM PRATENSE TOP
- WATER
- ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 43857-0535 | 43857-0535-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pollen 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 | BioActive Nutritional, Inc. | 8b9fa995-47a4-4b2d-9db8-5f4c6eccbd16 | 2024-10-17 | Warnings | 43857-0535-1 43857-0535 43857053501 6af21280-f2cd-40ac-adc7-52f1e10c3575 8b9fa995-47a4-4b2d-9db8-5f4c6eccbd16 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.