Borago Nicotiana

Product NDC
48951-2077
11-digit product format
489512077
Labeler code
48951
Product ID
48951-2077_53872d71-7ff6-38cc-e063-6294a90a9913
Type
HUMAN OTC DRUG
Nonproprietary name
Borago Nicotiana
Dosage form
LIQUID
Route
ORAL
Labeler
Uriel Pharmacy Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2009-09-01
Substance
BORAGE; CENTAUREA BENEDICTA; HAMAMELIS VIRGINIANA LEAF; TOBACCO LEAF; ALUMINUM OXIDE; FERROUS ARSENATE; HORSE CHESTNUT
Active strength
3; 3; 3; 6; 8; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Borago Nicotiana
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BORAGE3 [hp_X]/mL
CENTAUREA BENEDICTA3 [hp_X]/mL
HAMAMELIS VIRGINIANA LEAF3 [hp_X]/mL
TOBACCO LEAF6 [hp_X]/mL
ALUMINUM OXIDE8 [hp_X]/mL
FERROUS ARSENATE10 [hp_X]/mL
HORSE CHESTNUT10 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PB618V0K2WInternal UNII lookup
6L5ZL09795Internal UNII lookup
T07U1161SVInternal UNII lookup
6YR2608RSUInternal UNII lookup
LMI26O6933Internal UNII lookup
129CO35H12Internal UNII lookup
3C18L6RJAZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
306f9eee-877b-46ee-9a36-894fa321b3d3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-2077-1Borago Nicotiana10 in 1 BOXLIQUID102
48951-2077-1Borago Nicotiana1 mL in 1 AMPULELIQUID12

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-2077BORAGO NICOTIANA LIQUID [URIEL PHARMACY INC.]2Current NDC, Legacy NDC, 2 package rows20180518_306f9eee-877b-46ee-9a36-894fa321b3d3.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
Borago NicotianaBORAGO NICOTIANAUriel Pharmacy Inc.306f9eee-877b-46ee-9a36-894fa321b3d32026-06-05WarningsExact identifier
ndc (product): 48951-2077

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48951-2077-14895120770110 AMPULE in 1 BOX (48951-2077-1) / 1 mL in 1 AMPULE10 ampule2009-09-010000-00-00NoNoCurrent