FDA.reportPublic FDA data

Enuresis

Product NDC
43857-0217
11-digit product format
438570217
Labeler code
43857
Product ID
43857-0217_99a44b58-29e7-4016-ba9a-d883823a0589
Type
HUMAN OTC DRUG
Nonproprietary name
Equisetum Hyemale, Solidago Virgaurea, Uva-Ursi, Argentum Metallicum, Causticum, Kreosotum, Nitricum Acidum, Sepia, Thuja Occidentalis
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-04-01
Substance
ARCTOSTAPHYLOS UVA-URSI LEAF; CAUSTICUM; EQUISETUM HYEMALE; NITRIC ACID; SEPIA OFFICINALIS JUICE; SILVER; SOLIDAGO VIRGAUREA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; WOOD CREOSOTE
Active strength
3; 12; 3; 12; 12; 12; 3; 12; 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; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Enuresis
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARCTOSTAPHYLOS UVA-URSI LEAF3 [hp_X]/mL
CAUSTICUM12 [hp_X]/mL
EQUISETUM HYEMALE3 [hp_X]/mL
NITRIC ACID12 [hp_X]/mL
SEPIA OFFICINALIS JUICE12 [hp_X]/mL
SILVER12 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP3 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG12 [hp_X]/mL
WOOD CREOSOTE12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M5V3D1X36, DD5FO1WKFU, 59677RXH25, 411VRN1TV4, QDL83WN8C2, 3M4G523W1G, 5405K23S50, 1NT28V9397, 3JYG22FD73

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0217-1Enuresis30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARCTOSTAPHYLOS UVA-URSI LEAFACTIVE INGREDIENT3M5V3D1X36ENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
CAUSTICUMACTIVE INGREDIENTDD5FO1WKFUENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
EQUISETUM HYEMALEACTIVE INGREDIENT59677RXH25ENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
NITRIC ACIDACTIVE INGREDIENT411VRN1TV4ENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C2ENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
SILVERACTIVE INGREDIENT3M4G523W1GENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE INGREDIENT5405K23S50ENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V9397ENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
WOOD CREOSOTEACTIVE INGREDIENT3JYG22FD73ENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
ARCTOSTAPHYLOS UVA-URSI LEAFACTIVE MOIETY3M5V3D1X36ENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
CAUSTICUMACTIVE MOIETYDD5FO1WKFUENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
EQUISETUM HYEMALEACTIVE MOIETY59677RXH25ENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
NITRIC ACIDACTIVE MOIETY411VRN1TV4ENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C2ENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
SILVERACTIVE MOIETY3M4G523W1GENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE MOIETY5405K23S50ENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V9397ENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
WOOD CREOSOTEACTIVE MOIETY3JYG22FD73ENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0217ENURESIS (EQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20170615_22105dde-b570-4af6-a7b8-e942f649e934.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0217-14385702170130 mL in 1 BOTTLE, DROPPER (43857-0217-1) 30 ml2017-06-140000-00-00NoNoCurrent