Urodel (Healwell) DA

Urodel by

Drug Labeling and Warnings

Urodel by is a Homeopathic medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

URODEL- cantharis, clematis, cubeba, echinacea, ranunculus bulbosus, sabal serrulata, staphysagria, uva ursi tablet, chewable 
Pharmadel LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Urodel (Healwell) DA

Drug Facts

Active Ingredients & Purposes

• Active ingredients** (HPUS) (in each 300 mg tablet contains equal parts of:):

  Purposes*

• Cantharis vesicatoria 6X .....................:

  Sharp burning pain during urination

• Clematis erecta 6X ...............................:

  Burning sensation

• Cubeba officinalis 6X .............................:

  Frequent urination, yellow discharge

• Echinacea angustifolia 6X .....................:

  Bladder inflammation

• Ranunculus bulbosus 6X ......................: Frequent urging to urinate
• Sabal serrulata 6X ........................................: Painful urination
• Staphysagria 6X ..................................:

  Pressure on the bladder

• Uva ursi 6X ............................................:

  Constant urination and straining

The letters HPUS indicate that this ingredient is officially included in the homeopathic Pharmacopeia of the United States.

Uses*

Temporarily relieves symptoms associated with urinary tract infections

• burning sensation when urinating
• frequent urge to urinate
• painful urination
• bladder inflammation

Warnings

Stop use and ask a doctor if

• symptoms persist, worsen, reoccur or are severe
• you experience fever, chills, back pain, or bloody urine
• an allergic reaction occurs, seek medical help right away

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of the reach of children.

In case of an overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years of age and older: take at least 15 minutes prior to eating food or drinking. Slightly chew one (1) tablet and allow it to dissolve in the mouth. Use 3 times a day or up to 6 times a day for intense symptoms. Reduce to one tablet daily for 7 days after symptoms improve.

• children under 12 years of age: do not use

Other information

• store between 59°-86°F (15°-30°C) and protect from light
• do not use if seal over cap is torn, broken, or missing

Inactive ingredients

croscarmellose sodium, dextrose, lactose, magnesium stearate, microcrystalline cellulose

Questions & comments?

1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

PRINCIPAL DISPLAY PANEL

URODEL 
cantharis, clematis, cubeba, echinacea, ranunculus bulbosus, sabal serrulata, staphysagria, uva ursi tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-406
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F)	CLEMATIS RECTA FLOWERING TOP	6 [hp_X]
PIPER CUBEBA FRUIT (UNII: Z99L7429MA) (PIPER CUBEBA FRUIT - UNII:Z99L7429MA)	PIPER CUBEBA FRUIT	6 [hp_X]
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	6 [hp_X]
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) (ARCTOSTAPHYLOS UVA-URSI LEAF - UNII:3M5V3D1X36)	ARCTOSTAPHYLOS UVA-URSI LEAF	6 [hp_X]
RANUNCULUS BULBOSUS (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB)	RANUNCULUS BULBOSUS	6 [hp_X]
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS)	SAW PALMETTO	6 [hp_X]
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	6 [hp_X]
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
DEXTROSE (UNII: IY9XDZ35W2)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white (White Tablet)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-406-30	1 in 1 CARTON	11/07/2023	12/31/2025
1		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/07/2023	12/31/2025

Labeler - Pharmadel LLC (030129680)

Revised: 8/2025

Document Id: 3bdf040f-d0a4-e6db-e063-6394a90aaf3f

34390-5

Set id: 0427bbc9-f4cc-0eb6-e063-6294a90a7199

Version: 2

Effective Time: 20250808