Probentra

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Probentra
Generic name: PROBIOTIC DIETARY SUPPLEMENT CAPSULES
Manufacturer: Oncora Pharma, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 7c0e1b3e-f1a3-451d-a5c6-45bdf13274f8
SPL ID: e357f4a7-006b-4dcf-8f8c-8157f5f817ef
Version: 1
Effective date: 2026-02-25
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:56:28

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Probentra	openfda.brand_name
generic name		PROBIOTIC DIETARY SUPPLEMENT CAPSULES	openfda.generic_name
manufacturer name		Oncora Pharma, LLC	openfda.manufacturer_name
ndc	package	85477-712-30	openfda.package_ndc
ndc	product	85477-712	openfda.product_ndc
ndc11	package	85477071230	derived:openfda.package_ndc
spl id		e357f4a7-006b-4dcf-8f8c-8157f5f817ef	id
spl set id		7c0e1b3e-f1a3-451d-a5c6-45bdf13274f8	set_id
unii		GXW9U52VV9	openfda.unii
unii		N2UDM48ZD6	openfda.unii
unii		QFC21096ON	openfda.unii
unii		K1YRS2QLN2	openfda.unii
unii		D4S8K64J5Z	openfda.unii
unii		HTV58LVI9P	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

WARNINGS AND PRECAUTIONS If pregnant, nursing, or attempting to conceive, consult a licensed healthcare professional prior to use. Keep out of reach of children. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six years of age. In case of accidental overdose, call a physician or poison control center immediately.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Probiotic supplementation may occasionally result in mild gastrointestinal symptoms such as bloating, gas, or abdominal discomfort. If adverse reactions occur, discontinue use and consult a healthcare professional.

Reported adverse events (FAERS/openFDA)#

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