FDA.reportPublic FDA data

Primula Onopordon

Product NDC
48951-8314
11-digit product format
489518314
Labeler code
48951
Product ID
48951-8314_6dfb6620-c0ba-3a34-e053-2a91aa0a95d2
Type
HUMAN OTC DRUG
Nonproprietary name
Primula Onopordon
Dosage form
PELLET
Route
ORAL
Labeler
Uriel Pharmacy Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2009-09-01
Marketing end
0000-00-00
Substance
ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS; HYOSCYAMUS NIGER
Active strength
3 [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct48951-8314IInactivated by FDA2026-10-05
excluded packagepackage48951-831448951-8314-2IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-8314-2Primula Onopordon1350 in 1 BOTTLE, GLASSPELLET13505

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYOSCYAMUS NIGERACTIVE INGREDIENT4WRK2153H3PRIMULA ONOPORDON STRESS RELIEF (PRIMULA VERIS EXTRACT ONOPORDUM HYOSCYAMUS NIGER) PELLET [URIEL PHARMACY INC]2
ONOPORDUM ACANTHIUM FLOWERACTIVE INGREDIENTAP97AUF88EPRIMULA ONOPORDON STRESS RELIEF (PRIMULA VERIS EXTRACT ONOPORDUM HYOSCYAMUS NIGER) PELLET [URIEL PHARMACY INC]2
PRIMULA VERISACTIVE INGREDIENTW6LFQ57E4MPRIMULA ONOPORDON STRESS RELIEF (PRIMULA VERIS EXTRACT ONOPORDUM HYOSCYAMUS NIGER) PELLET [URIEL PHARMACY INC]2
HYOSCYAMUS NIGERACTIVE MOIETY4WRK2153H3PRIMULA ONOPORDON STRESS RELIEF (PRIMULA VERIS EXTRACT ONOPORDUM HYOSCYAMUS NIGER) PELLET [URIEL PHARMACY INC]2
ONOPORDUM ACANTHIUM FLOWERACTIVE MOIETYAP97AUF88EPRIMULA ONOPORDON STRESS RELIEF (PRIMULA VERIS EXTRACT ONOPORDUM HYOSCYAMUS NIGER) PELLET [URIEL PHARMACY INC]2
PRIMULA VERISACTIVE MOIETYW6LFQ57E4MPRIMULA ONOPORDON STRESS RELIEF (PRIMULA VERIS EXTRACT ONOPORDUM HYOSCYAMUS NIGER) PELLET [URIEL PHARMACY INC]2
SUCROSEINACTIVE INGREDIENTC151H8M554PRIMULA ONOPORDON STRESS RELIEF (PRIMULA VERIS EXTRACT ONOPORDUM HYOSCYAMUS NIGER) PELLET [URIEL PHARMACY INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-8314PRIMULA ONOPORDON PELLET [URIEL PHARMACY INC]5Legacy NDC, 1 package rows20240306_58eb7cb5-5d49-403e-bc2d-bb92d8bf9ca3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48951-8314-2489518314021350 PELLET in 1 BOTTLE, GLASS (48951-8314-2) 1350 pellet2009-09-010000-00-00NoNoCurrent