FDA.reportPublic FDA data

Borago Nicotiana

Product NDC
48951-2078
11-digit product format
489512078
Labeler code
48951
Product ID
48951-2078_6d86921f-ad11-31a5-e053-2a91aa0a6a25
Type
HUMAN OTC DRUG
Nonproprietary name
Borago Nicotiana
Dosage form
PELLET
Route
ORAL
Labeler
Uriel Pharmacy Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2009-09-01
Marketing end
0000-00-00
Substance
BORAGO OFFICINALIS WHOLE; CENTAUREA BENEDICTA; HAMAMELIS VIRGINIANA LEAF; TOBACCO LEAF; ALUMINUM OXIDE; HORSE CHESTNUT; FERROUS ARSENATE
Active strength
3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [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 productproduct48951-2078IInactivated by FDA2026-10-05
excluded packagepackage48951-207848951-2078-2IInactivated 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
48951-2078-2Borago Nicotiana1350 in 1 BOTTLE, GLASSPELLET13505

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM OXIDEACTIVE INGREDIENTLMI26O6933BORAGO NICOTIANA PELLET [URIEL PHARMACY INC.]1
BORAGO OFFICINALIS WHOLEACTIVE INGREDIENT69R58A6YLIBORAGO NICOTIANA PELLET [URIEL PHARMACY INC.]1
CENTAUREA BENEDICTAACTIVE INGREDIENT6L5ZL09795BORAGO NICOTIANA PELLET [URIEL PHARMACY INC.]1
FERROUS ARSENATEACTIVE INGREDIENT129CO35H12BORAGO NICOTIANA PELLET [URIEL PHARMACY INC.]1
HAMAMELIS VIRGINIANA LEAFACTIVE INGREDIENTT07U1161SVBORAGO NICOTIANA PELLET [URIEL PHARMACY INC.]1
HORSE CHESTNUTACTIVE INGREDIENT3C18L6RJAZBORAGO NICOTIANA PELLET [URIEL PHARMACY INC.]1
TOBACCO LEAFACTIVE INGREDIENT6YR2608RSUBORAGO NICOTIANA PELLET [URIEL PHARMACY INC.]1
ALUMINUM OXIDEACTIVE MOIETYLMI26O6933BORAGO NICOTIANA PELLET [URIEL PHARMACY INC.]1
BORAGO OFFICINALIS WHOLEACTIVE MOIETY69R58A6YLIBORAGO NICOTIANA PELLET [URIEL PHARMACY INC.]1
CENTAUREA BENEDICTAACTIVE MOIETY6L5ZL09795BORAGO NICOTIANA PELLET [URIEL PHARMACY INC.]1
FERROUS ARSENATEACTIVE MOIETY129CO35H12BORAGO NICOTIANA PELLET [URIEL PHARMACY INC.]1
HAMAMELIS VIRGINIANA LEAFACTIVE MOIETYT07U1161SVBORAGO NICOTIANA PELLET [URIEL PHARMACY INC.]1
HORSE CHESTNUTACTIVE MOIETY3C18L6RJAZBORAGO NICOTIANA PELLET [URIEL PHARMACY INC.]1
TOBACCO LEAFACTIVE MOIETY6YR2608RSUBORAGO NICOTIANA PELLET [URIEL PHARMACY INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554BORAGO NICOTIANA PELLET [URIEL PHARMACY INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-2078BORAGO NICOTIANA PELLET [URIEL PHARMACY INC.]5Legacy NDC, 1 package rows20240919_427284b7-1f0d-435f-a3d6-7c653a719aa9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48951-2078-2489512078021350 PELLET in 1 BOTTLE, GLASS (48951-2078-2) 1350 pellet2009-09-010000-00-00NoNoCurrent