FDA.reportPublic FDA data

Uterus 13X

Product NDC
53645-2540
11-digit product format
536452540
Labeler code
53645
Product ID
53645-2540_522dc678-ab93-e381-e063-6394a90abedc
Type
HUMAN OTC DRUG
Nonproprietary name
Uterus 13X
Dosage form
LIQUID
Route
ORAL
Labeler
True Botanica, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-05-19
Substance
BOS TAURUS UTERUS
Active strength
13 [hp_X]/30mL
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Uterus 13XUTERUS 13XTrue Botanica, LLC522de56a-7aaa-0ba3-e063-6394a90ad4582026-05-19WarningsExact identifier
ndc (product): 53645-2540

Additional Listing Data#

Finished product
Yes
Brand name base
Uterus 13X
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BOS TAURUS UTERUS13 [hp_X]/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9169LW451GInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
522de56a-7aaa-0ba3-e063-6394a90ad458Available on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
53645-2540-65364525400630 mL in 1 BOTTLE (53645-2540-6)30 ml2026-05-190Current