Histastat Food

Product NDC
44911-0574
Requested package NDC
44911-0574-1
11-digit product format
449110574
Labeler code
44911
Product ID
44911-0574_bd7626fb-a61d-4532-ad27-488dbe92e613
Type
HUMAN OTC DRUG
Nonproprietary name
Chelidonium Majus, Echinacea (Angustifolia), Gentiana Lutea, Arsenicum Album, Carbo Vegetabilis, Lycopodium Clavatum, Nux Vomica, Phosphorus, Pulsatilla (Pratensis)
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-04-22
Substance
CHELIDONIUM MAJUS WHOLE; ECHINACEA ANGUSTIFOLIA WHOLE; GENTIANA LUTEA ROOT; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA PRATENSIS WHOLE
Active strength
3; 3; 3; 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
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…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 Food
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHELIDONIUM MAJUS WHOLE3 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA WHOLE3 [hp_X]/mL
GENTIANA LUTEA ROOT3 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
ACTIVATED CHARCOAL12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE12 [hp_X]/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-07-26DRUG FACTS:
2024-07-26DRUG FACTS:
2023-01-30DRUG FACTS:
2023-01-30DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0574-1Histastat Food30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0574HISTASTAT FOOD (CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GENTIANA LUTEA, ARSENICUM ALBUM, CARBO VEGETABILIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS)) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20240727_e9d6b64f-9b20-422c-91f6-c26def4d53d0.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 FoodCHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GENTIANA LUTEA, ARSENICUM ALBUM, CARBO VEGETABILIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS)Energique, Inc.e9d6b64f-9b20-422c-91f6-c26def4d53d02024-07-26WarningsExact identifier
ndc (package): 44911-0574-1
ndc (product): 44911-0574
ndc11 (package): 44911057401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0574-14491105740130 mL in 1 BOTTLE, DROPPER (44911-0574-1) 30 ml2021-04-220000-00-00NoNoCurrent