FDA.reportPublic FDA data

Bladder Irritation and UTI

Product NDC
61727-353
11-digit product format
617270353
Labeler code
61727
Product ID
61727-353_84796173-945e-c70b-e053-2991aa0a4ee1
Type
HUMAN OTC DRUG
Nonproprietary name
Cantharis, Clematis, Cubeba, Echinacea, Ranunculus bulbosus, Sabal ser, Staphysagria, Uva ursi
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
HomeoCare Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-03-19
Substance
ARCTOSTAPHYLOS UVA-URSI LEAF; CLEMATIS RECTA FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA ANGUSTIFOLIA; LYTTA VESICATORIA; PIPER CUBEBA FRUIT; RANUNCULUS BULBOSUS; SERENOA REPENS WHOLE
Active strength
6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bladder Irritation and UTI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARCTOSTAPHYLOS UVA-URSI LEAF6 [hp_X]/601
CLEMATIS RECTA FLOWERING TOP6 [hp_X]/601
DELPHINIUM STAPHISAGRIA SEED6 [hp_X]/601
ECHINACEA ANGUSTIFOLIA6 [hp_X]/601
LYTTA VESICATORIA6 [hp_X]/601
PIPER CUBEBA FRUIT6 [hp_X]/601
RANUNCULUS BULBOSUS6 [hp_X]/601
SERENOA REPENS WHOLE6 [hp_X]/601

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M5V3D1X36, 396421SP9F, 00543AP1JV, VB06AV5US8, 3Q034RO3BT, Z99L7429MA, AEQ8NXJ0MB, 487DXM62F2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61727-353-60Bladder Irritation and UTI60 in 1 BOTTLETABLET, CHEWABLE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61727-353BLADDER IRRITATION AND UTI (CANTHARIS, CLEMATIS, CUBEBA, ECHINACEA, RANUNCULUS BULBOSUS, SABAL SER, STAPHYSAGRIA, UVA URSI) TABLET, CHEWABLE [HOMEOCARE LABORATORIES, INC.]1Current NDC, Legacy NDC, 1 package rows20190321_84796173-945d-c70b-e053-2991aa0a4ee1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61727-353-606172703536060 TABLET, CHEWABLE in 1 BOTTLE (61727-353-60) 2019-03-190000-00-00NoNoCurrent