Gastrotone

Product NDC: 44911-0455
Requested package NDC: 44911-0455-1
11-digit product format: 449110455
Labeler code: 44911
Product ID: 44911-0455_0007cd0a-4506-4d05-bc9a-d834ac7b5963
Type: HUMAN OTC DRUG
Nonproprietary name: Gentiana Lutea, Sambucus Nigra, Arsenicum Album, Kali Bichromicum, Lycopodium Clavatum, Phosphorus, Pulsatilla (Vulgaris), Bismuthum Subnitricum
Dosage form: LIQUID
Route: ORAL
Labeler: Energique, Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2018-05-08
Marketing end: 2025-11-03
Substance: ANEMONE PULSATILLA; ARSENIC TRIOXIDE; BISMUTH SUBNITRATE; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; POTASSIUM DICHROMATE; SAMBUCUS NIGRA FLOWERING TOP
Active strength: 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
Pharmacologic classes: Bismuth [CS], Bismuth [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	44911-0455	44911-0455-1	D	Discontinued by firm		2026-10-15

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	44911-0455	44911-0455-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15	Product name	1	20240313

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44911-0455	GASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA (VULGARIS), BISMUTHUM SUBNITRICUM) LIQUID [ENERGIQUE, INC.]	2	Legacy NDC	20220318_2d15e40e-86b8-425d-ad20-100ff3e21b55.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I76KB35JEV	ANEMONE PULSATILLA		ANEMONE PULSATILLA
S7V92P67HO	ARSENIC TRIOXIDE	1327-53-3	ARSENIC TRIOXIDE
H19J064BA5	BISMUTH SUBNITRATE	1304-85-4	BISMUTH SUBNITRATE
S72O3284MS	GENTIANA LUTEA ROOT		GENTIANA LUTEA ROOT
C88X29Y479	LYCOPODIUM CLAVATUM SPORE	8023-70-9	LYCOPODIUM CLAVATUM SPORE
27YLU75U4W	PHOSPHORUS	7723-14-0	PHOSPHORUS
T4423S18FM	POTASSIUM DICHROMATE	7778-50-9	POTASSIUM DICHROMATE
CT03BSA18U	SAMBUCUS NIGRA FLOWERING TOP		SAMBUCUS NIGRA FLOWERING TOP

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44911-0455-1	44911045501	30 mL in 1 BOTTLE, DROPPER (44911-0455-1)	30 ml	2018-05-08	2025-11-03	No	No	Current