FDA.reportPublic FDA data

Histastat Pollen

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:28:25

Label at a glance#

ProductHistastat Pollen
Active ingredientBAPTISIA TINCTORIA ROOT, ECHINACEA ANGUSTIFOLIA, ONION, AMBROSIA ARTEMISIIFOLIA, ARSENIC TRIOXIDE, EUPHRASIA STRICTA, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, ANEMONE PRATENSIS, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional.  Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 9.98% of Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Euphrasia Officinalis 12X, Natrum Sulphuricum 12X, Phosphorus 12X, Pulsatilla (Pratensis) 12X, Solidago Virgaurea 12X, Sulphur 12X;0.10% of Baptisia Tinctoria 3X, Echinacea (Angustifolia) 3X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve sinus congestion due to hay fever and allergic rhinitis.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health 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 a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve sinus congestion due to hay fever and allergic rhinitis.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800-869-8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

HISTASTAT POLLEN

2 fl. oz. (60 ml)

HISTASTAT POLLENHISTASTAT POLLEN

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0576-12024-10-25C16284748780-1f386c649-d9c7-0266-e053-dadaa90a7c1aDrug Facts
44911-0576-12023-01-30C16284748780-1f386c649-d9c7-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0576-1Histastat Pollen60 mL in 1 BOTTLE, DROPPERLIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0576HISTASTAT POLLEN (BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SOLIDAGO VIRGAUREA, SULPHUR) LIQUID [ENERGIQUE, INC.]2Legacy NDC, 1 package rows20241027_4e70a71c-125a-45f3-871b-591d5d2788a8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-057644911-0576-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
ONION492225Q21HACTIB
AMBROSIA ARTEMISIIFOLIA9W34L2CQ9AACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
SODIUM SULFATE0YPR65R21JACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PRATENSIS8E272251DIACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
SULFUR70FD1KFU70ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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
00100cb8-7c7f-40d2-9ae6-8ffc40e13d4b4e70a71c-125a-45f3-871b-591d5d2788a82024-10-25WarningsExact identifier
spl id: 00100cb8-7c7f-40d2-9ae6-8ffc40e13d4b
spl set id: 4e70a71c-125a-45f3-871b-591d5d2788a8

Reported adverse events (FAERS/openFDA)#

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