FDA.reportPublic FDA data

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
AMBROSIA ARTEMISIIFOLIA; ANEMONE PRATENSIS; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; EUPHRASIA STRICTA; ONION; PHOSPHORUS; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR
Active strength
12; 12; 12; 3; 3; 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

Additional Listing Data#

Finished product
Yes
Brand name base
Histastat Pollen

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9W34L2CQ9A, 8E272251DI, S7V92P67HO, 5EF0HWI5WU, VB06AV5US8, C9642I91WL, 492225Q21H, 27YLU75U4W, 0YPR65R21J, 5405K23S50, 269XH13919, 70FD1KFU70

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

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