FDA.reportPublic FDA data

Urinary Tract Drops

Product NDC
63083-2122
11-digit product format
630832122
Labeler code
63083
Product ID
63083-2122_6d4accd2-7cde-4299-8316-2110b1971291
Type
HUMAN OTC DRUG
Nonproprietary name
Urinary Tract Drops
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
AGATHOSMA BETULINA LEAF; BEEF KIDNEY; CAUSTICUM; CHIMAPHILA UMBELLATA WHOLE; CRATEVA MAGNA BARK; DELPHINIUM STAPHISAGRIA SEED; EQUISETUM ARVENSE TOP; LYTTA VESICATORIA; SEPIA OFFICINALIS JUICE; SMILAX ORNATA ROOT; SUS SCROFA URINARY BLADDER; TOXICODENDRON PUBESCENS LEAF; URTICA URENS WHOLE
Active strength
6; 6; 30; 30; 3; 60; 6; 12; 60; 12; 6; 12; 30 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Urinary Tract Drops
Brand name suffix
2122
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AGATHOSMA BETULINA LEAF6 [hp_X]/59mL
BEEF KIDNEY6 [hp_X]/59mL
CAUSTICUM30 [hp_X]/59mL
CHIMAPHILA UMBELLATA WHOLE30 [hp_X]/59mL
CRATEVA MAGNA BARK3 [hp_X]/59mL
DELPHINIUM STAPHISAGRIA SEED60 [hp_X]/59mL
EQUISETUM ARVENSE TOP6 [hp_X]/59mL
LYTTA VESICATORIA12 [hp_X]/59mL
SEPIA OFFICINALIS JUICE60 [hp_X]/59mL
SMILAX ORNATA ROOT12 [hp_X]/59mL
SUS SCROFA URINARY BLADDER6 [hp_X]/59mL
TOXICODENDRON PUBESCENS LEAF12 [hp_X]/59mL
URTICA URENS WHOLE30 [hp_X]/59mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii369DDH39Z0, 5HOC10FSIC, DD5FO1WKFU, WCK21A9W9J, RS704ZO5ZL, 00543AP1JV, 1DP6Y6B65Z, 3Q034RO3BT, QDL83WN8C2, 2H1576D5WG, 3G7U72W8DA, 6IO182RP7A, IHN2NQ5OF9

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-2122-22026-01-09C16284748780-11030e365-37da-111a-e063-dadaa90a10e2C122
63083-2122-22026-01-09C16284748780-11030e365-37da-111a-e063-dadaa90a10e2C122
63083-2122-22024-01-30C16284748780-11030e365-37da-111a-e063-dadaa90a10e2C122
63083-2122-22024-01-30C16284748780-11030e365-37da-111a-e063-dadaa90a10e2C122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-2122-2Urinary Tract Drops212259 mL in 1 BOTTLE, DROPPERLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-2122URINARY TRACT DROPS 2122 (URINARY TRACT DROPS) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220216_0373cd9c-73d5-4994-94ef-fe7084b633f6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-2122-26308321220259 mL in 1 BOTTLE, DROPPER (63083-2122-2) 59 ml1985-08-150000-00-00NoNoCurrent