FDA.reportPublic FDA data

Urinary Comfort

Product NDC
76472-7011
Requested package NDC
76472-7011-2
11-digit product format
764727011
Labeler code
76472
Product ID
76472-7011_594f4c4f-f5d5-7852-e063-6294a90a61f2
Type
HUMAN OTC DRUG
Nonproprietary name
Berberis vulgaris 3C, Solidago virgaurea 3C, Spiraea Ulmaria 3C
Dosage form
SPRAY
Route
BUCCAL
Labeler
SEVENE USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-08-19
Substance
BERBERIS VULGARIS ROOT BARK; SOLIDAGO VIRGAUREA FLOWERING TOP; FILIPENDULA ULMARIA ROOT
Active strength
.1; .1; .1 mg/100mL; mg/100mL; mg/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Urinary Comfort
Brand name suffix
Urinary discomfort
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BERBERIS VULGARIS ROOT BARK.1 mg/100mL
SOLIDAGO VIRGAUREA FLOWERING TOP.1 mg/100mL
FILIPENDULA ULMARIA ROOT.1 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1TH8Q20J0UInternal UNII lookup
5405K23S50Internal UNII lookup
997724QNDSInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5501026c-9edb-8f89-e063-6394a90a7d5cAvailable on FDA.report

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
Urinary Comfort Urinary discomfortBERBERIS VULGARIS 3C, SOLIDAGO VIRGAUREA 3C, SPIRAEA ULMARIA 3CSEVENE USA5501026c-9edb-8f89-e063-6394a90a7d5c2026-08-18WarningsExact identifier
ndc (package): 76472-7011-2
ndc (product): 76472-7011
ndc11 (package): 76472701102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76472-7011-2764727011021 BOTTLE, SPRAY in 1 BOX (76472-7011-2) / 30 mL in 1 BOTTLE, SPRAY (76472-7011-1) 2026-08-19NoNoCurrent