Home NDC 53645-1631 Tormentilla
Product NDC 53645-1631
11-digit product format 536451631
Labeler code 53645
Product ID 53645-1631_fe91dac8-d543-9b91-e053-6394a90a2fc2
Type HUMAN OTC DRUG
Nonproprietary name Tormentilla
Dosage form GLOBULE
Route ORAL
Labeler True Botanica, LLC
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2023-06-20
Substance POTENTILLA ERECTA ROOT
Active strength 30 [hp_X]/23g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Tormentilla
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTENTILLA ERECTA ROOT 30 [hp_X]/23g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BI896CKT6B Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53645-1631-2 Tormentilla 23 g in 1 BOTTLE GLOBULE 23 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53645-1631 TORMENTILLA GLOBULE [TRUE BOTANICA, LLC] 1 Current NDC, 1 package rows 20230710_fe91f114-364e-59a5-e053-6294a90a7514.zip
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53645-1631-2 53645163102 23 g in 1 BOTTLE (53645-1631-2) 23 g 2023-06-20 No No Current