SABAL SERRULATA

Product NDC
15631-0381
Requested package NDC
15631-0381-5
11-digit product format
156310381
Labeler code
15631
Product ID
15631-0381_cd2679a5-ffc3-1611-e053-2a95a90acedd
Type
HUMAN OTC DRUG
Nonproprietary name
SABAL SERRULATA
Dosage form
PELLET
Route
ORAL
Labeler
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-10-31
Substance
SAW PALMETTO
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 packagepackage15631-038115631-0381-5EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Additional Listing Data#

Finished product
Yes
Brand name base
SABAL SERRULATA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SAW PALMETTO1 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J7WWH9M8QSInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
05396d68-f339-4e48-886a-724a3a8ba63eAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-0381-0SABAL SERRULATA100 in 1 VIAL, SINGLE-DOSEPELLET1003
15631-0381-1SABAL SERRULATA200 in 1 PACKAGEPELLET2003
15631-0381-2SABAL SERRULATA400 in 1 PACKAGEPELLET4003
15631-0381-3SABAL SERRULATA750 in 1 PACKAGEPELLET7503
15631-0381-4SABAL SERRULATA2500 in 1 PACKAGEPELLET25003
15631-0381-5SABAL SERRULATA12500 in 1 PACKAGEPELLET125003
15631-0381-6SABAL SERRULATA500 in 1 PACKAGEPELLET5003
15631-0381-7SABAL SERRULATA1000 in 1 PACKAGEPELLET10003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SAW PALMETTOACTIVE INGREDIENTJ7WWH9M8QSSABAL SERRULATA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1
SAW PALMETTOACTIVE MOIETYJ7WWH9M8QSSABAL SERRULATA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554SABAL SERRULATA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-0381SABAL SERRULATA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]3Current NDC, Legacy NDC, 8 package rows20211001_05396d68-f339-4e48-886a-724a3a8ba63e.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
SABAL SERRULATASABAL SERRULATARxhomeo Private Limited d.b.a. Rxhomeo, Inc05396d68-f339-4e48-886a-724a3a8ba63e2021-09-29WarningsExact identifier
ndc (package): 15631-0381-5
ndc (product): 15631-0381
ndc11 (package): 15631038105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15631-0381-51563103810512500 PELLET in 1 PACKAGE (15631-0381-5) 12500 pellet2018-01-010000-00-00NoNoCurrent