FDA.reportPublic FDA data

Gastrotone

Product NDC
44911-0563
11-digit product format
449110563
Labeler code
44911
Product ID
44911-0563_4d7a01db-50f9-482e-b8d7-fbb87386968f
Type
HUMAN OTC DRUG
Nonproprietary name
Gentiana Lutea, Sambucus Nigra, Arsenicum Album, Kali Bichromicum, Lycopodium Clavatum, Phosphorus, Pulsatilla (Pratensis), Bismuthum Subnitricum
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-10-13
Substance
ARSENIC TRIOXIDE; BISMUTH SUBNITRATE; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA PRATENSIS WHOLE; SAMBUCUS NIGRA FLOWERING TOP
Active strength
12; 15; 3; 12; 12; 12; 12; 3 [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
Bismuth [CS], Bismuth [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gastrotone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE12 [hp_X]/mL
BISMUTH SUBNITRATE15 [hp_X]/mL
GENTIANA LUTEA ROOT3 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
POTASSIUM DICHROMATE12 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE12 [hp_X]/mL
SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS7V92P67HO, H19J064BA5, S72O3284MS, C88X29Y479, 27YLU75U4W, T4423S18FM, 8E272251DI, CT03BSA18U

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0563-12024-10-24C16284748780-1d6a99b39-cb18-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0563-12024-01-30C16284748780-1d6a99b39-cb18-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0563-12022-06-28C16284748780-1d6a99b39-cb18-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0563-12022-01-28C16284748780-1d6a99b39-cb18-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0563-1Gastrotone30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0563GASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA (PRATENSIS), BISMUTHUM SUBNITRICUM) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20241027_3e93ca93-0c1e-4305-bf0f-efd44c30a9d3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0563-14491105630130 mL in 1 BOTTLE, DROPPER (44911-0563-1) 30 ml2020-10-130000-00-00NoNoCurrent