Allium Cepa

Product NDC
53645-1721
11-digit product format
536451721
Labeler code
53645
Product ID
53645-1721_faa48e9c-a345-c745-e053-6294a90a9b21
Type
HUMAN OTC DRUG
Nonproprietary name
Allium Cepa
Dosage form
GLOBULE
Route
ORAL
Labeler
True Botanica, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-12-30
Substance
ALLIUM CEPA WHOLE
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
Allium Cepa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLIUM CEPA WHOLE30 [hp_X]/23g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8P2VLG2456Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6190e9c0-2ded-6d16-e053-2a91aa0ae5ccAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53645-1721-22021-01-31C16284748780-1ba0f9c33-211a-a910-e053-dadaa90a0b85Allium Cepa 30x
53645-1721-22021-01-29C16284748780-1ba0f9c33-211a-a910-e053-dadaa90a0b85Allium Cepa 30x

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53645-1721-2Allium Cepa23 g in 1 BOTTLEGLOBULE235

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53645-1721ALLIUM CEPA GLOBULE [TRUE BOTANICA, LLC]5Current NDC, Legacy NDC, 1 package rows20230502_6190e9c0-2ded-6d16-e053-2a91aa0ae5cc.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allium CepaALLIUM CEPATrue Botanica, LLC6190e9c0-2ded-6d16-e053-2a91aa0ae5cc2023-05-01WarningsExact identifier
ndc (product): 53645-1721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53645-1721-25364517210223 g in 1 BOTTLE (53645-1721-2) 23 g2017-12-300000-00-00NoNoCurrent