FDA.reportPublic FDA data

Bedwetting

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:39:53

Label at a glance#

ProductBedwetting
Active ingredientAtropa Belladonna, Lytta Vesicatoria, Causticum, Equisetum Hyemale, Iron, Gelsemium Sempervirens Root, Hops, Potassium Phosphate, Dibasic, Lycopodium Clavatum Spore, Sodium Chloride, Plantago Major, Pulsatilla Vulgaris, Rhus Aromatica Root Bark, Saw Palmetto, Thyroid, Unspecified, Verbascum Thapsus, Echinacea, Unspecified, Goldenseal, Passiflora Incarnata Flowering Top, Valerian
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Bedwetting    Formulated for associated symptoms often related to fear, nervousness, muscle tone, trauma and bladder weakness.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 drops) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Belladonna 15x, Cantharis 15x ,Causticum 15x, Equisetum hyemale 15x, Ferrum metallicum 15x, Gelsemium 15x, Humulus 15x, Kali phos. 15x, Lycopodium 15x, Nat.mur. 15x, Plantago 15x, Pulsatilla 15x, Rhus aromatica 15x,Sabal 15x, Thyroidinum 15x, Verbascum 15x, Echinacea 3x, Hydrastis 3x, Passiflora 3x, Valeriana 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms often related to fear, nervousness, muscle tone, trauma and bladder weakness.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.  

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256 

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-1513-02020-01-31C16284748780-19d75b9d0-12f1-f424-e053-dadaa90a57ceBedwetting
55714-1513-12020-01-31C16284748780-19d75b9d0-12f1-f424-e053-dadaa90a57ceBedwetting
55714-1513-22020-01-31C16284748780-19d75b9d0-12f1-f424-e053-dadaa90a57ceBedwetting

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-1513BEDWETTING (BELLADONNA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, HUMULUS, KALI PHOS., LYCOPODIUM, NAT.MUR., PLANTAGO, PULSATILLA, RHUS AROMATICA, SABAL, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTIS, PASSIFLORA, VALERIANA) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC20130829_cccc2bbe-3860-f121-9f44-78210b59e6f0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H1
CausticumACTIVE INGREDIENTDD5FO1WKFU1
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
Equisetum HyemaleACTIVE INGREDIENT59677RXH251
Gelsemium Sempervirens RootACTIVE INGREDIENT639KR60Q1Q1
GoldensealACTIVE INGREDIENTZW3Z11D0JV1
HopsACTIVE INGREDIENT01G73H6H831
IronACTIVE INGREDIENTE1UOL152H71
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT1
Passiflora Incarnata Flowering TopACTIVE INGREDIENTCLF5YFS11O1
Plantago MajorACTIVE INGREDIENTW2469WNO6U1
Potassium Phosphate, DibasicACTIVE INGREDIENTCI71S98N1Z1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
Rhus Aromatica Root BarkACTIVE INGREDIENTQ3H36W0J421
Saw PalmettoACTIVE INGREDIENTJ7WWH9M8QS1
Sodium ChlorideACTIVE INGREDIENT451W47IQ8X1
Thyroid, UnspecifiedACTIVE INGREDIENT0B4FDL9I6P1
ValerianACTIVE INGREDIENTJWF5YAW3QW1
Verbascum ThapsusACTIVE INGREDIENTC9TD27U1721
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H1
CausticumACTIVE MOIETYDD5FO1WKFU1
Chloride IonACTIVE MOIETYQ32ZN486981
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
Equisetum HyemaleACTIVE MOIETY59677RXH251
Gelsemium Sempervirens RootACTIVE MOIETY639KR60Q1Q1
GoldensealACTIVE MOIETYZW3Z11D0JV1
HopsACTIVE MOIETY01G73H6H831
IronACTIVE MOIETYE1UOL152H71
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT1
Passiflora Incarnata Flowering TopACTIVE MOIETYCLF5YFS11O1
Phosphate IonACTIVE MOIETYNK08V8K8HR1
Plantago MajorACTIVE MOIETYW2469WNO6U1
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
Rhus Aromatica Root BarkACTIVE MOIETYQ3H36W0J421
Saw PalmettoACTIVE MOIETYJ7WWH9M8QS1
Thyroid, UnspecifiedACTIVE MOIETY0B4FDL9I6P1
ValerianACTIVE MOIETYJWF5YAW3QW1
Verbascum ThapsusACTIVE MOIETYC9TD27U1721
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-151355714-1513-1, 55714-1513-2, 55714-1513-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
Atropa BelladonnaWQZ3G9PF0HACTIB
Lytta Vesicatoria3Q034RO3BTACTIB
CausticumDD5FO1WKFUACTIB
Equisetum Hyemale59677RXH25ACTIB
IronE1UOL152H7ACTIB
Gelsemium Sempervirens Root639KR60Q1QACTIB
Hops01G73H6H83ACTIB
Potassium Phosphate, DibasicCI71S98N1ZACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Sodium Chloride451W47IQ8XACTIB
Plantago MajorW2469WNO6UACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Rhus Aromatica Root BarkQ3H36W0J42ACTIB
Saw PalmettoJ7WWH9M8QSACTIB
Thyroid, Unspecified0B4FDL9I6PACTIB
Verbascum ThapsusC9TD27U172ACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
GoldensealZW3Z11D0JVACTIB
Passiflora Incarnata Flowering TopCLF5YFS11OACTIB
ValerianJWF5YAW3QWACTIB
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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 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
4a2f38d8-9326-8274-e063-6394a90a4297cccc2bbe-3860-f121-9f44-78210b59e6f02026-02-06WarningsExact identifier
spl set id: cccc2bbe-3860-f121-9f44-78210b59e6f0

Reported adverse events (FAERS/openFDA)#

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