Gastrotone

Product NDC
57520-0355
Requested package NDC
57520-0355-1
11-digit product format
575200355
Labeler code
57520
Product ID
57520-0355_0d4103db-4db9-4ad3-a5e1-f4a1fa131795
Type
HUMAN OTC DRUG
Nonproprietary name
Gentiana lutea, Sambucus nigra, Arsenicum album, Kali bichromicum, Lycopodium clavatum, Phosphorus, Pulsatilla Bismuthum carbonicum,
Dosage form
LIQUID
Route
ORAL
Labeler
Apotheca Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-04-29
Marketing end
2022-08-31
Substance
ARSENIC TRIOXIDE; BISMUTH SUBCARBONATE; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; 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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage57520-035557520-0355-1DDiscontinued by firm2026-10-12

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57520-0355-12022-03-29C16284748780-19d75b9d0-8a0a-f424-e053-dadaa90a57ceGastrotone
57520-0355-12020-01-31C16284748780-19d75b9d0-8a0a-f424-e053-dadaa90a57ceGastrotone

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HOGASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3
BISMUTH SUBCARBONATEACTIVE INGREDIENTM41L2IN55TGASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3
GENTIANA LUTEA ROOTACTIVE INGREDIENTS72O3284MSGASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y479GASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3
PHOSPHORUSACTIVE INGREDIENT27YLU75U4WGASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3
POTASSIUM DICHROMATEACTIVE INGREDIENTT4423S18FMGASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEVGASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3
SAMBUCUS NIGRA FLOWERING TOPACTIVE INGREDIENTCT03BSA18UGASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3
ARSENIC TRIOXIDEACTIVE MOIETYS7V92P67HOGASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3
BISMUTH CATIONACTIVE MOIETYZS9CD1I8YEGASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3
GENTIANA LUTEA ROOTACTIVE MOIETYS72O3284MSGASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y479GASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3
PHOSPHORUSACTIVE MOIETY27YLU75U4WGASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3
POTASSIUM CATIONACTIVE MOIETY295O53K152GASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEVGASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3
SAMBUCUS NIGRA FLOWERING TOPACTIVE MOIETYCT03BSA18UGASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MGASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3
WATERINACTIVE INGREDIENT059QF0KO0RGASTROTONE (GENTIANA LUTEA, SAMBUCUS NIGRA, ARSENICUM ALBUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, PULSATILLA BISMUTHUM CARBONICUM,) LIQUID [APOTHECA COMPANY]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57520-0355-15752003550130 mL in 1 BOTTLE, DROPPER (57520-0355-1) 30 ml2010-04-292022-08-31NoNoCurrent