FDA.reportPublic FDA data

Enuresis

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2016-09-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:09

Label at a glance#

ProductEnuresis HP
Active ingredientSILVER NITRATE, ATROPA BELLADONNA, CAUSTICUM, EQUISETUM HYEMALE, WOOD CREOSOTE, NITRIC ACID, PULSATILLA VULGARIS, 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

Argentum Nitricum 30X, Belladonna 30X, Causticum 30X, Equisetum Hyemale 30X, Kreosotum 30X, Nitricum Acidum 30X, Pulsatilla (Vulgaris) 30X, Thuja Occidentalis 30X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of symptoms due to bedwetting and bladder conditions.

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 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 symptoms due to bedwetting and bladder conditions.

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 Nutritional

ENURESIS-HP

HOMEOPATHIC

1 FL OZ (30 ml)

Enuresis HPEnuresis HP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0413-1EnuresisHP30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0413ENURESIS HP (ARGENTUM NITRICUM, BELLADONNA, CAUSTICUM, EQUISETUM HYEMALE, KREOSOTUM, NITRICUM ACIDUM, PULSATILLA (VULGARIS), THUJA OCCIDENTALIS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1Current NDC, Legacy NDC, 1 package rows20160909_a6fff9be-e78d-4539-b741-6a8080a164a0.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-041343857-0413-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILVER NITRATE95IT3W8JZEACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
CAUSTICUMDD5FO1WKFUACTIB
EQUISETUM HYEMALE59677RXH25ACTIB
WOOD CREOSOTE3JYG22FD73ACTIB
NITRIC ACID411VRN1TV4ACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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
Enuresis HPARGENTUM NITRICUM, BELLADONNA, CAUSTICUM, EQUISETUM HYEMALE, KREOSOTUM, NITRICUM ACIDUM, PULSATILLA (VULGARIS), THUJA OCCIDENTALISBioActive Nutritional, Inc.a6fff9be-e78d-4539-b741-6a8080a164a02016-09-07WarningsExact identifier
ndc (package): 43857-0413-1
ndc (product): 43857-0413
ndc11 (package): 43857041301
spl id: 7c629ce8-9dcb-4750-b23d-d40c12f62954
spl set id: a6fff9be-e78d-4539-b741-6a8080a164a0

Reported adverse events (FAERS/openFDA)#

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