FDA.reportPublic FDA data

AVENA SATIVA

Product NDC
15631-0069
Requested package NDC
15631-0069-6
11-digit product format
156310069
Labeler code
15631
Product ID
15631-0069_cf05b059-b374-6204-e053-2a95a90a273d
Type
HUMAN OTC DRUG
Nonproprietary name
AVENA SATIVA
Dosage form
PELLET
Route
ORAL
Labeler
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-09-12
Substance
AVENA SATIVA FLOWERING TOP
Active strength
1 [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
AVENA SATIVA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVENA SATIVA FLOWERING TOP1 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MA9CQJ3F7FInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0d174ce9-262b-44bb-9d23-beccd300374cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
15631-0069-02020-02-170d174ce9-262b-44bb-9d23-beccd300374c
15631-0069-12020-02-170d174ce9-262b-44bb-9d23-beccd300374c
15631-0069-22020-02-170d174ce9-262b-44bb-9d23-beccd300374c
15631-0069-32020-02-170d174ce9-262b-44bb-9d23-beccd300374c
15631-0069-42020-02-170d174ce9-262b-44bb-9d23-beccd300374c
15631-0069-52020-02-170d174ce9-262b-44bb-9d23-beccd300374c
15631-0069-02020-01-310d174ce9-262b-44bb-9d23-beccd300374c
15631-0069-12020-01-310d174ce9-262b-44bb-9d23-beccd300374c
15631-0069-22020-01-310d174ce9-262b-44bb-9d23-beccd300374c
15631-0069-32020-01-310d174ce9-262b-44bb-9d23-beccd300374c
15631-0069-42020-01-310d174ce9-262b-44bb-9d23-beccd300374c
15631-0069-52020-01-310d174ce9-262b-44bb-9d23-beccd300374c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-0069-0AVENA SATIVA100 in 1 PACKAGEPELLET1003
15631-0069-1AVENA SATIVA200 in 1 PACKAGEPELLET2003
15631-0069-2AVENA SATIVA400 in 1 PACKAGEPELLET4003
15631-0069-3AVENA SATIVA750 in 1 PACKAGEPELLET7503
15631-0069-4AVENA SATIVA2500 in 1 PACKAGEPELLET25003
15631-0069-5AVENA SATIVA12500 in 1 PACKAGEPELLET125003
15631-0069-6AVENA SATIVA500 in 1 PACKAGEPELLET5003
15631-0069-7AVENA SATIVA1000 in 1 PACKAGEPELLET10003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVENA SATIVA FLOWERING TOPACTIVE INGREDIENTMA9CQJ3F7FAVENA SATIVA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1
AVENA SATIVA FLOWERING TOPACTIVE MOIETYMA9CQJ3F7FAVENA SATIVA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554AVENA SATIVA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-0069AVENA SATIVA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]3Current NDC, Legacy NDC, 8 package rows20211024_0d174ce9-262b-44bb-9d23-beccd300374c.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
AVENA SATIVAAVENA SATIVARxhomeo Private Limited d.b.a. Rxhomeo, Inc0d174ce9-262b-44bb-9d23-beccd300374c2021-10-23WarningsExact identifier
ndc (package): 15631-0069-6
ndc (product): 15631-0069
ndc11 (package): 15631006906

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15631-0069-615631006906500 PELLET in 1 PACKAGE (15631-0069-6) 500 pellet2021-08-230000-00-00NoNoCurrent