FDA.reportPublic FDA data

Bladder Calm

Product NDC
76472-7012
Requested package NDC
76472-7012-2
11-digit product format
764727012
Labeler code
76472
Product ID
76472-7012_594f4a54-2572-401e-e063-6394a90aa6b4
Type
HUMAN OTC DRUG
Nonproprietary name
Equisetum Hyemale 3C, Formica Rufa 5C, Urtica urens 3C, Uva Ursi 3C
Dosage form
SPRAY
Route
BUCCAL
Labeler
SEVENE USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-08-19
Substance
FORMICA RUFA; URTICA URENS; EQUISETUM HYEMALE; ARCTOSTAPHYLOS UVA-URSI LEAF
Active strength
.1; .1; .1; .1 mg/100mL; 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
Bladder Calm
Brand name suffix
Urinary Infection
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FORMICA RUFA.1 mg/100mL
URTICA URENS.1 mg/100mL
EQUISETUM HYEMALE.1 mg/100mL
ARCTOSTAPHYLOS UVA-URSI LEAF.1 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
55H0W83JO5Internal UNII lookup
IHN2NQ5OF9Internal UNII lookup
59677RXH25Internal UNII lookup
3M5V3D1X36Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5510749a-1aaa-152a-e063-6294a90aa2ffAvailable 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
Bladder Calm Urinary InfectionEQUISETUM HYEMALE 3C, FORMICA RUFA 5C, URTICA URENS 3C, UVA URSI 3CSEVENE USA5510749a-1aaa-152a-e063-6294a90aa2ff2026-08-18WarningsExact identifier
ndc (package): 76472-7012-2
ndc (product): 76472-7012
ndc11 (package): 76472701202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76472-7012-2764727012021 BOTTLE, SPRAY in 1 BOX (76472-7012-2) / 30 mL in 1 BOTTLE, SPRAY (76472-7012-1) 2026-08-19NoNoCurrent