Gastrotone

Product NDC: 44911-0563
Requested package NDC: 44911-0563-1
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: GENTIANA LUTEA ROOT; SAMBUCUS NIGRA FLOWERING TOP; ARSENIC TRIOXIDE; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA PRATENSIS WHOLE; BISMUTH SUBNITRATE
Active strength: 3; 3; 12; 12; 12; 12; 12; 15 [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

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 · 7 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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: Gastrotone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GENTIANA LUTEA ROOT	3 [hp_X]/mL
SAMBUCUS NIGRA FLOWERING TOP	3 [hp_X]/mL
ARSENIC TRIOXIDE	12 [hp_X]/mL
POTASSIUM DICHROMATE	12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE	12 [hp_X]/mL
PHOSPHORUS	12 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE	12 [hp_X]/mL
BISMUTH SUBNITRATE	15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
S72O3284MS	Internal UNII lookup
CT03BSA18U	Internal UNII lookup
S7V92P67HO	Internal UNII lookup
T4423S18FM	Internal UNII lookup
C88X29Y479	Internal UNII lookup
27YLU75U4W	Internal UNII lookup
8E272251DI	Internal UNII lookup
H19J064BA5	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3e93ca93-0c1e-4305-bf0f-efd44c30a9d3	Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-10-24	DRUG FACTS:
2024-01-30	DRUG FACTS:
2022-06-28	DRUG FACTS:
2022-01-28	DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44911-0563-1	Gastrotone	30 mL in 1 BOTTLE, DROPPER	LIQUID	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44911-0563	GASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA (PRATENSIS), BISMUTHUM SUBNITRICUM) LIQUID [ENERGIQUE, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20241027_3e93ca93-0c1e-4305-bf0f-efd44c30a9d3.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gastrotone	GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA (PRATENSIS), BISMUTHUM SUBNITRICUM	Energique, Inc.	3e93ca93-0c1e-4305-bf0f-efd44c30a9d3	2024-10-24	Warnings	Exact identifier ndc (package): 44911-0563-1 ndc (product): 44911-0563 ndc11 (package): 44911056301

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44911-0563-1	44911056301	30 mL in 1 BOTTLE, DROPPER (44911-0563-1)	30 ml	2020-10-13	0000-00-00	No	No	Current