FDA.reportPublic FDA data

Biomexa

Manufacturer
Oncora Pharma, LLC
Effective date
2026-05-12
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:52:56

Label at a glance#

ProductBiomexa
Active ingredientLactobacillus Acidophilus, Bifidobacterium Animalis Lactis
Label structure13 sections

Dosage and administration

Usual adult dose is 1 capsule once or twice daily or as prescribed by a licensed medical practitioner.

Storage and handling

Store 15°- 30°C (59°-86°F) [See USP Controlled Room Temperature.] Avoid excessive heat, light, moisture and exceeding 85% humidity. Keep in a cool, dry place.

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Biomexa 85477-0714-30
Dietary Supplement
Dispensed by Prescription

DESCRIPTION

HEALTH CLAIM SECTION

Biomexa is an orally administered prescription probiotic dietary supplement.

STATEMENT OF IDENTITY SECTION

Supplement Facts
Serving size 1 Capsule
Amount per Serving: % Daily Value
Lactobacillus Acidophilus16 Billion*
Bifidobacterium Animalis Lactis15 Billion*

* Daily value not established

INDICATIONS

HEALTH CLAIM SECTION

Biomexa is an orally administered prescription probiotic formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed. Biomexa should be administered under the supervision of a licensed medical practitioner.

CONTRAINDICATIONS

HEALTH CLAIM SECTION

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING

WARNINGS SECTION

Biomexa should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking other medications.

ADVERSE REACTIONS

HEALTH CLAIM SECTION

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact Oncora Pharma, LLC at 1-833-242-4493

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Usual adult dose is 1 capsule once or twice daily or as prescribed by a licensed medical practitioner.

HOW SUPPLIED

HEALTH CLAIM SECTION

Bottle of 30 capsules (85477-0714-30). Capsule is tan , oval.

STORAGE AND HANDLING

HEALTH CLAIM SECTION

Store 15°- 30°C (59°-86°F) [See USP Controlled Room Temperature.] Avoid excessive heat, light, moisture and exceeding 85% humidity. Keep in a cool, dry place.

TAMPER EVIDENT

HEALTH CLAIM SECTION

Do not use if seal is broken or missing.

HEALTH CLAIM SECTION

MADE IN USA

Manufacturer for:

Oncora Pharma LLC

Dallas TX 75228

833-242-4493

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any diseases.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

85477-0714-30

Biomexa

PROBIOTIC SUPPORT

30 CAPSULES

Dispensed by Prescription

pdp
pdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2043695Lactobacillus acidophilus 16 Billion UNT / Bifidobacterium animalis 15 Billion UNT Oral CapsulePSN1
2043695Bifidobacterium animalis 15000000000 UNT / Lactobacillus acidophilus 16000000000 UNT Oral CapsuleSCD1
2043695Bifidobacterium animalis 15,000,000,000 UNT / Lactobacillus acidophilus 16,000,000,000 UNT Oral CapsuleSY1
2043695Bifidobacterium animalis lactis 15,000,000,000 UNT / Lactobacillus acidophilus 16,000,000,000 UNT Oral CapsuleSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130854770714304GTIN-13: 0854770714304
EAN-13: 0854770714304
GTIN-12: 854770714304
UPC-A: 854770714304
GTIN storage (14 digits): 00854770714304		biomexa-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85477-714-30Biomexa30 in 1 BOTTLECAPSULE301

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85477-71485477-714-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
Lactobacillus Acidophilus1PRR1V42V5ACTIB
Bifidobacterium Animalis Lactis5307V7XW8IACTIB
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
Silicon DioxideETJ7Z6XBU4IACT
MAGNESIUM PALMITOSTEARATER4OXA9G5BVIACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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