HYDRASTIS CANADENSIS

Product NDC
15631-0226
Requested package NDC
15631-0226-4
11-digit product format
156310226
Labeler code
15631
Product ID
15631-0226_cce596b5-69f8-f886-e053-2995a90af79a
Type
HUMAN OTC DRUG
Nonproprietary name
HYDRASTIS CANADENSIS
Dosage form
PELLET
Route
ORAL
Labeler
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-10-02
Substance
GOLDENSEAL
Active strength
1 [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage15631-022615631-0226-4EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Additional Listing Data#

Finished product
Yes
Brand name base
HYDRASTIS CANADENSIS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GOLDENSEAL1 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZW3Z11D0JVInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c4cd528f-43f7-40ae-b29c-7060616d5867Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-0226-0HYDRASTIS CANADENSIS100 in 1 PACKAGEPELLET1003
15631-0226-1HYDRASTIS CANADENSIS200 in 1 PACKAGEPELLET2003
15631-0226-2HYDRASTIS CANADENSIS400 in 1 PACKAGEPELLET4003
15631-0226-3HYDRASTIS CANADENSIS750 in 1 PACKAGEPELLET7503
15631-0226-4HYDRASTIS CANADENSIS2500 in 1 PACKAGEPELLET25003
15631-0226-5HYDRASTIS CANADENSIS12500 in 1 PACKAGEPELLET125003
15631-0226-6HYDRASTIS CANADENSIS500 in 1 PACKAGEPELLET5003
15631-0226-7HYDRASTIS CANADENSIS1000 in 1 PACKAGEPELLET10003

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-0226HYDRASTIS CANADENSIS PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]3Current NDC, Legacy NDC, 8 package rows20210927_c4cd528f-43f7-40ae-b29c-7060616d5867.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
HYDRASTIS CANADENSISHYDRASTIS CANADENSISRxhomeo Private Limited d.b.a. Rxhomeo, Incc4cd528f-43f7-40ae-b29c-7060616d58672021-09-26WarningsExact identifier
ndc (package): 15631-0226-4
ndc (product): 15631-0226
ndc11 (package): 15631022604

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15631-0226-4156310226042500 PELLET in 1 PACKAGE (15631-0226-4) 2500 pellet2018-01-010000-00-00NoNoCurrent