Home NDC 44911-0563 Gastrotone
Product NDC 44911-0563
11-digit product format 449110563
Labeler code 44911
Product ID 44911-0563_ee561305-99e2-476a-8c41-8851424ea25b
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
Marketing end 2029-03-04
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
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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 44911-0563-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 44911-0563-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 44911-0563-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 44911-0563-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 44911-0563-1 1332a3947898…d4bfe170f9cd…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 44911-0563-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 44911-0563-1 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 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
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# 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
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 2029-03-04 No No Current