FDA.reportPublic FDA data

Cystoges

Product NDC
43857-0064
11-digit product format
438570064
Labeler code
43857
Product ID
43857-0064_680c28dc-cf8e-4731-a117-e056697fc8f7
Type
HUMAN OTC DRUG
Nonproprietary name
Berberis Vulgaris, Cantharis, Clematis Erecta, Lac Caninum, Lycopodium Clavatum, Pulsatilla (Vulgaris), Sarsaparilla, Sepia, Staphysagria
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2012-10-26
Substance
BERBERIS VULGARIS ROOT BARK; CANIS LUPUS FAMILIARIS MILK; CLEMATIS RECTA FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SMILAX ORNATA ROOT
Active strength
30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cystoges
Brand name suffix
HP
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BERBERIS VULGARIS ROOT BARK30 [hp_X]/mL
CANIS LUPUS FAMILIARIS MILK30 [hp_X]/mL
CLEMATIS RECTA FLOWERING TOP30 [hp_X]/mL
DELPHINIUM STAPHISAGRIA SEED30 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE30 [hp_X]/mL
LYTTA VESICATORIA30 [hp_X]/mL
PULSATILLA VULGARIS30 [hp_X]/mL
SEPIA OFFICINALIS JUICE30 [hp_X]/mL
SMILAX ORNATA ROOT30 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1TH8Q20J0U, G39P120JQT, 396421SP9F, 00543AP1JV, C88X29Y479, 3Q034RO3BT, I76KB35JEV, QDL83WN8C2, 2H1576D5WG

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0064-12023-11-03C16284748780-19d75b9d0-40a8-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0064-12020-01-31C16284748780-19d75b9d0-40a8-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0064-1CystogesHP30 mL in 1 BOTTLE, DROPPERLIQUID305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BERBERIS VULGARIS ROOT BARKACTIVE INGREDIENT1TH8Q20J0UCYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
CANIS LUPUS FAMILIARIS MILKACTIVE INGREDIENTG39P120JQTCYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
CLEMATIS RECTA FLOWERING TOPACTIVE INGREDIENT396421SP9FCYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
DELPHINIUM STAPHISAGRIA SEEDACTIVE INGREDIENT00543AP1JVCYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y479CYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
LYTTA VESICATORIAACTIVE INGREDIENT3Q034RO3BTCYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEVCYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C2CYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
SMILAX REGELII ROOTACTIVE INGREDIENT2H1576D5WGCYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
BERBERIS VULGARIS ROOT BARKACTIVE MOIETY1TH8Q20J0UCYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
CANIS LUPUS FAMILIARIS MILKACTIVE MOIETYG39P120JQTCYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
CLEMATIS RECTA FLOWERING TOPACTIVE MOIETY396421SP9FCYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
DELPHINIUM STAPHISAGRIA SEEDACTIVE MOIETY00543AP1JVCYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y479CYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
LYTTA VESICATORIAACTIVE MOIETY3Q034RO3BTCYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEVCYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
SARSAPARILLAACTIVE MOIETY2H1576D5WGCYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C2CYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MCYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA, SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0064CYSTOGES HP (BERBERIS VULGARIS, CANTHARIS, CLEMATIS ERECTA, LAC CANINUM, LYCOPODIUM CLAVATUM, PULSATILLA (VULGARIS), SARSAPARILLA, SEPIA, STAPHYSAGRIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]4Current NDC, Legacy NDC, 1 package rows20231104_1c13ec7c-1d7f-4ca3-be42-efa995afa749.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43857-0064-14385700640130 mL in 1 BOTTLE, DROPPER (43857-0064-1) 30 ml2016-07-05NoNoHistorical