Home NDC 53645-1501 Hyoscyamus Niger
Product NDC 53645-1501
11-digit product format 536451501
Labeler code 53645
Product ID 53645-1501_faa4d67c-b95a-f5e8-e053-6294a90a9fb1
Type HUMAN OTC DRUG
Nonproprietary name Hyoscymus Niger
Dosage form GLOBULE
Route ORAL
Labeler True Botanica, LLC
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2014-02-03
Substance HYOSCYAMUS NIGER
Active strength 6 [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 Hyoscyamus Niger
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYOSCYAMUS NIGER 6 [hp_X]/23g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4WRK2153H3 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53645-1501-2 Hyoscyamus Niger 23 g in 1 BOTTLE GLOBULE 23 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53645-1501 HYOSCYAMUS NIGER (HYOSCYMUS NIGER) GLOBULE [TRUE BOTANICA, LLC] 5 Current NDC, Legacy NDC, 1 package rows 20230502_61953eb2-1f6c-06c7-e053-2a91aa0a0ae4.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 Marketing end Sample Exclude flag Status 53645-1501-2 53645150102 23 g in 1 BOTTLE (53645-1501-2) 23 g 2014-02-03 0000-00-00 No No Current