FDA.reportPublic FDA data

GI Clear P

Product NDC
44911-0611
11-digit product format
449110611
Labeler code
44911
Product ID
44911-0611_787bc0d6-e847-4983-b9eb-e1bbba4c7c9c
Type
HUMAN OTC DRUG
Nonproprietary name
Arsenicum Album, Baptisia Tinctoria, Lachesis Mutus, Pulsatilla (Pratensis), Rhus Tox
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-06-21
Marketing end
2028-12-12
Substance
ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; LACHESIS MUTA VENOM; PULSATILLA PRATENSIS WHOLE; TOXICODENDRON PUBESCENS LEAF
Active strength
10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GI Clear P

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE10 [hp_X]/mL
BAPTISIA TINCTORIA ROOT10 [hp_X]/mL
LACHESIS MUTA VENOM10 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE10 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF10 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS7V92P67HO, 5EF0HWI5WU, VSW71SS07I, 8E272251DI, 6IO182RP7A

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0611-12023-11-17C16284748780-1f386c64a-1d4a-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0611-12023-01-30C16284748780-1f386c64a-1d4a-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0611-1GI Clear P60 mL in 1 BOTTLE, DROPPERLIQUID603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0611GI CLEAR P (ARSENICUM ALBUM, BAPTISIA TINCTORIA, LACHESIS MUTUS, PULSATILLA (PRATENSIS), RHUS TOX) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20250519_9aca850f-7e18-4147-aaf1-f6f04047f7f3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0611-14491106110160 mL in 1 BOTTLE, DROPPER (44911-0611-1) 60 ml2021-06-212028-12-12NoNoCurrent