FDA.reportPublic FDA data

Bionara ULTRA

Product NDC
85477-710
11-digit product format
854770710
Labeler code
85477
Product ID
85477-710_6cd37233-b8b5-4018-b1e4-07611306a562
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Probiotic Dietary Supplement Capsules
Dosage form
CAPSULE
Route
ORAL
Labeler
Oncora Pharma, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-02-23
Substance
LACTOBACILLUS ACIDOPHILUS LA 14; BIFIDOBACTERIUM ANIMALIS LACTIS BL04; LACTIPLANTIBACILLUS PLANTARUM; LACTICASEIBACILLUS PARACASEI LPC-37; LESSONIA NIGRESCENS; BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES
Active strength
410; 410; 410; 410; 25; 10 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
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
Bionara ULTRA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACTOBACILLUS ACIDOPHILUS LA 14410 mg/1
BIFIDOBACTERIUM ANIMALIS LACTIS BL04410 mg/1
LACTIPLANTIBACILLUS PLANTARUM410 mg/1
LACTICASEIBACILLUS PARACASEI LPC-37410 mg/1
LESSONIA NIGRESCENS25 mg/1
BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D4S8K64J5ZInternal UNII lookup
K1YRS2QLN2Internal UNII lookup
QFC21096ONInternal UNII lookup
GXW9U52VV9Internal UNII lookup
HTV58LVI9PInternal UNII lookup
N2UDM48ZD6Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc5e4d0b-03ac-43a5-9155-8f3ceb9504ccAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85477-710-30Bionara ULTRA30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85477-710-30EA - Each85477-710dcc3a1eb-be45-4ace-a7a8-be924f64483312026-04-20

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
Bionara ULTRAPROBIOTIC DIETARY SUPPLEMENT CAPSULESOncora Pharma, LLCbc5e4d0b-03ac-43a5-9155-8f3ceb9504cc2026-02-25WarningsExact identifier
ndc (product): 85477-710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85477-710-308547707103030 CAPSULE in 1 BOTTLE (85477-710-30) 30 capsule2026-02-23NoNoCurrent