FDA.reportPublic FDA data

Bionara ULTRA

Manufacturer
Oncora Pharma, LLC
Effective date
2026-02-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:07:31

Label at a glance#

ProductBionara ULTRA
Active ingredientLACTOBACILLUS ACIDOPHILUS LA 14, BIFIDOBACTERIUM ANIMALIS LACTIS BL04, LACTIPLANTIBACILLUS PLANTARUM, LACTICASEIBACILLUS PARACASEI LPC-37, LESSONIA NIGRESCENS, BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES
Label structure8 sections

Indications and uses

Bionara Ultra™ is a prescription probiotic supplement intended to support gastrointestinal health and maintain normal intestinal flora balance. Dispensed by prescription under medical supervision.

Dosage and administration

Usual adult dose is 2 capsules once or twice daily or as prescribed by a licensed medical practitioner.

Storage and handling

Store at 20°–25°C (68°–77°F) . Excursions permitted to 15°–30°C (59°–86°F) [See USP Controlled Room Temperature]. Avoid excessive heat, light, moisture, and exceeding 85% humidity.

Label contents#

Full prescribing information#

PRODUCT DESCRIPTION

DESCRIPTION SECTION

Bionara Ultra™ is a prescription probiotic dietary supplement containing a proprietary blend of probiotic bacteria providing 60 billion CFU per serving (2 capsules), combined with prebiotic and polysaccharide support ingredients.

Each serving (2 capsules) contains 820 mg of proprietary probiotic blend delivering 60 billion CFU, including:

  • MATREK® (Bi-Pass Technology)
  • Lactobacillus acidophilus (La-14)
  • Bifidobacterium lactis (Bl-04)
  • Lactobacillus plantarum (Lp-115)
  • Lactobacillus paracasei (Lpc-37)

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Bionara Ultra™ is a prescription probiotic supplement intended to support gastrointestinal health and maintain normal intestinal flora balance.

Dispensed by prescription under medical supervision.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Usual adult dose is 2 capsules once or twice daily or as prescribed by a licensed medical practitioner.

WARNINGS

WARNINGS SECTION

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. In case of accidental overdose, call a doctor or poison control center immediately.

If pregnant, lactating, or trying to conceive, consult with a licensed healthcare professional prior to use.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

None known.

STORAGE

STORAGE AND HANDLING SECTION

Store at 20°–25°C (68°–77°F).
Excursions permitted to 15°–30°C (59°–86°F) [See USP Controlled Room Temperature].

Avoid excessive heat, light, moisture, and exceeding 85% humidity.

HOW SUPPLIED

HOW SUPPLIED SECTION

Bionara Ultra™ is supplied as:

  • 30 capsules per bottle
  • NDC 85477-710-30

MANUFACTURER INFORMATION

Manufactured for:
Oncora Pharma
Dallas, TX 75228

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

85477-710-30
Bionara
ULTRA
60 billion CFU
30 Capsules

85477-710-30 Bionara ULTRA 60 billion CFU 30 Capsules85477-710-30 Bionara ULTRA 60 billion CFU 30 Capsules

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85477-71085477-710-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOBACILLUS ACIDOPHILUS LA 14D4S8K64J5ZACTIB
BIFIDOBACTERIUM ANIMALIS LACTIS BL04K1YRS2QLN2ACTIB
LACTIPLANTIBACILLUS PLANTARUMQFC21096ONACTIB
LACTICASEIBACILLUS PARACASEI LPC-37GXW9U52VV9ACTIB
LESSONIA NIGRESCENSHTV58LVI9PACTIB
BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDESN2UDM48ZD6ACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MALTODEXTRIN7CVR7L4A2DIACT
LEUCINEGMW67QNF9CIACT

Source Document#

Source XML

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 (package): 85477-710-30
ndc (product): 85477-710
ndc11 (package): 85477071030
spl id: 6cd37233-b8b5-4018-b1e4-07611306a562
spl set id: bc5e4d0b-03ac-43a5-9155-8f3ceb9504cc

Reported adverse events (FAERS/openFDA)#

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