Histastat Pollen

Product NDC
44911-0576
11-digit product format
449110576
Labeler code
44911
Product ID
44911-0576_00100cb8-7c7f-40d2-9ae6-8ffc40e13d4b
Type
HUMAN OTC DRUG
Nonproprietary name
Baptisia Tinctoria, Echinacea (Angustifolia), Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Euphrasia Officinalis, Natrum Sulphuricum, Nux Vomica, Phosphorus, Pulsatilla (Pratensis), Solidago Virgaurea, Sulphur
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-05-24
Marketing end
2026-10-11
Substance
BAPTISIA 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
Active strength
3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]
NDC exclude flag
No
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 packagepackage44911-0576-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage44911-0576-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage44911-0576-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage44911-0576-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage44911-0576-11332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Histastat Pollen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BAPTISIA TINCTORIA ROOT3 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA3 [hp_X]/mL
ONION12 [hp_X]/mL
AMBROSIA ARTEMISIIFOLIA12 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
EUPHRASIA STRICTA12 [hp_X]/mL
SODIUM SULFATE12 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
ANEMONE PRATENSIS12 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP12 [hp_X]/mL
SULFUR12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5EF0HWI5WUInternal UNII lookup
VB06AV5US8Internal UNII lookup
492225Q21HInternal UNII lookup
9W34L2CQ9AInternal UNII lookup
S7V92P67HOInternal UNII lookup
C9642I91WLInternal UNII lookup
0YPR65R21JInternal UNII lookup
269XH13919Internal UNII lookup
27YLU75U4WInternal UNII lookup
8E272251DIInternal UNII lookup
5405K23S50Internal UNII lookup
70FD1KFU70Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e70a71c-125a-45f3-871b-591d5d2788a8Available on FDA.report

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.]2Current NDC, Legacy NDC, 1 package rows20241027_4e70a71c-125a-45f3-871b-591d5d2788a8.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
Histastat PollenBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SOLIDAGO VIRGAUREA, SULPHUREnergique, Inc.4e70a71c-125a-45f3-871b-591d5d2788a82024-10-25WarningsExact identifier
ndc (product): 44911-0576

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0576-14491105760160 mL in 1 BOTTLE, DROPPER (44911-0576-1) 60 ml2021-05-242026-10-11NoNoCurrent