FDA.reportPublic FDA data

Enuresis

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2017-06-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:08:50

Label at a glance#

ProductEnuresis
Active ingredientEQUISETUM HYEMALE, SOLIDAGO VIRGAUREA FLOWERING TOP, ARCTOSTAPHYLOS UVA-URSI LEAF, SILVER, CAUSTICUM, WOOD CREOSOTE, NITRIC ACID, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG
Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Equisetum Hyemale 3X, Solidago Virgaurea 3X, Uva-Ursi 3X, Argentum Metallicum 12X, Causticum 12X, Kreosotum 12X, Nitricum Acidum 12X, Sepia 12X, Thuja Occidentalis 12X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of involuntary urination after falling asleep at night, and hurrying when desire comes to urinate.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of involuntary urination after falling asleep at night, and hurrying when desire comes to urinate.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioActive Homeopathic

ENURESIS

HOMEOPATHIC

1 FL OZ (30 ml)

ENURESISENURESIS

DailyMed Package Descriptions#

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

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARCTOSTAPHYLOS UVA-URSI LEAFACTIVE INGREDIENT3M5V3D1X362
CAUSTICUMACTIVE INGREDIENTDD5FO1WKFU2
EQUISETUM HYEMALEACTIVE INGREDIENT59677RXH252
NITRIC ACIDACTIVE INGREDIENT411VRN1TV42
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C22
SILVERACTIVE INGREDIENT3M4G523W1G2
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE INGREDIENT5405K23S502
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V93972
WOOD CREOSOTEACTIVE INGREDIENT3JYG22FD732
ARCTOSTAPHYLOS UVA-URSI LEAFACTIVE MOIETY3M5V3D1X362
CAUSTICUMACTIVE MOIETYDD5FO1WKFU2
EQUISETUM HYEMALEACTIVE MOIETY59677RXH252
NITRIC ACIDACTIVE MOIETY411VRN1TV42
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C22
SILVERACTIVE MOIETY3M4G523W1G2
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE MOIETY5405K23S502
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V93972
WOOD CREOSOTEACTIVE MOIETY3JYG22FD732
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-021743857-0217-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
EQUISETUM HYEMALE59677RXH25ACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36ACTIB
SILVER3M4G523W1GACTIB
CAUSTICUMDD5FO1WKFUACTIB
WOOD CREOSOTE3JYG22FD73ACTIB
NITRIC ACID411VRN1TV4ACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EnuresisEQUISETUM HYEMALE, SOLIDAGO VIRGAUREA, UVA-URSI, ARGENTUM METALLICUM, CAUSTICUM, KREOSOTUM, NITRICUM ACIDUM, SEPIA, THUJA OCCIDENTALISBioActive Nutritional, Inc.22105dde-b570-4af6-a7b8-e942f649e9342017-06-14WarningsExact identifier
ndc (package): 43857-0217-1
ndc (product): 43857-0217
ndc11 (package): 43857021701
spl id: 99a44b58-29e7-4016-ba9a-d883823a0589
spl set id: 22105dde-b570-4af6-a7b8-e942f649e934

Reported adverse events (FAERS/openFDA)#

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