FDA.reportPublic FDA data

Gastropar

Product NDC
44911-0425
11-digit product format
449110425
Labeler code
44911
Product ID
44911-0425_47e8134f-0d3c-4dfc-9003-2d0f0565aea8
Type
HUMAN OTC DRUG
Nonproprietary name
Gentiana Lutea, Sambucus Nigra, Stomach (Suis), Symphytum Officinale, Arsenicum Album, Bismuthum Subnitricum, Carbo Vegetabilis, Lycopodium Clavatum, Nux Vomica, Phosphorus
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-05-30
Substance
GENTIANA LUTEA ROOT; SAMBUCUS NIGRA FLOWERING TOP; SUS SCROFA STOMACH; COMFREY ROOT; ARSENIC TRIOXIDE; BISMUTH SUBNITRATE; ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS
Active strength
3; 3; 6; 6; 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
Pharmacologic classes
Allergens [CS], Bismuth [CS], Bismuth [EPC], 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
2026-12-31
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 · 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 packagepackage44911-0425-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage44911-0425-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage44911-0425-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage44911-0425-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage44911-0425-11332a3947898…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
Gastropar
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GENTIANA LUTEA ROOT3 [hp_X]/mL
SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]/mL
SUS SCROFA STOMACH6 [hp_X]/mL
COMFREY ROOT6 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
BISMUTH SUBNITRATE12 [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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S72O3284MSInternal UNII lookup
CT03BSA18UInternal UNII lookup
T0920P9Z9AInternal UNII lookup
M9VVZ08EKQInternal UNII lookup
S7V92P67HOInternal UNII lookup
H19J064BA5Internal UNII lookup
2P3VWU3H10Internal UNII lookup
C88X29Y479Internal UNII lookup
269XH13919Internal UNII lookup
27YLU75U4WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
128b917d-2d92-4c41-bbc4-09f916b822a5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-10-24DRUG FACTS:
2023-01-30DRUG FACTS:
2021-08-02DRUG FACTS:
2021-01-29DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0425-1Gastropar30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0425GASTROPAR (GENTIANA LUTEA, SAMBUCUS NIGRA, STOMACH (SUIS), SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CARBO VEGETABILIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]4Current NDC, Legacy NDC, 1 package rows20241027_128b917d-2d92-4c41-bbc4-09f916b822a5.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
GastroparGENTIANA LUTEA, SAMBUCUS NIGRA, STOMACH (SUIS), SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CARBO VEGETABILIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.128b917d-2d92-4c41-bbc4-09f916b822a52024-10-24WarningsExact identifier
ndc (product): 44911-0425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0425-14491104250130 mL in 1 BOTTLE, DROPPER (44911-0425-1) 30 ml2017-05-300000-00-00NoNoCurrent