FDA.reportPublic FDA data

Bacillex

Manufacturer
PureTek Corporation
Effective date
2025-06-26
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:51:49

Label at a glance#

ProductBacillex
Active ingredientLACTOBACILLUS ACIDOPHILUS
Label structure6 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY

STATEMENT OF IDENTITY SECTION

Bacillex™

Serving Size: 1 Capsule

Servings Per Container: 30

Amount Per Serving:

Proprietary Blend: 10 billion CFU (Colony Forming Units)
Lactobacillus acidophilus L59: Identified as the specific strain included in the blend

Other Ingredients: Magnesium Stearate, Microcrystalline Cellulose (MCC), Vegetable Capsule (HPMC).

Dosage & Administrationz:

DOSAGE & ADMINISTRATION SECTION

Usual Adult dose is one capsule daily, or as prescribed by a licensed healthcare practitioner. If you are pregnant or nursing, consult a licensed healthcare practitioner before use.

SAFE HANDLING

PRECAUTIONS SECTION

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

Bacillex™ should be administered under the supervision of a licensed healthcare practitioner, especially if pregnant, nursing, or under medical care.

†These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.

 KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Do not use if bottle seal is broken.

STORAGE

HEALTH CLAIM SECTION

Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature] Keep in a cool dry place.

HOW SUPPLIED HEALTH CLAIM

HEALTH CLAIM SECTION

Bacillex™, Probiotic

Dietary Supplement

NHRIC: 59088-019-54 *

Bottles contain 30 Capsules

Distributed in the USA by:
PureTek Corporation
Panorama City, CA 91402
Questions? Call toll-free:
1-877-921-7873

*Does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.

The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product by prescription. This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.

Bacillex™

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1370001Lactobacillus acidophilus 10 Billion UNT Oral CapsulePSN1
1370001Lactobacillus acidophilus 10000000000 UNT Oral CapsuleSCD1
1370001Lactobacillus acidophilus 10 Billion UNT Oral CapsuleSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-019-54Bacillex30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-019-54EA - Each59088-019dfbaf4e7-f6e5-466c-a078-c65953ba2be312025-08-11

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-01959088-019-54

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
LACTOBACILLUS ACIDOPHILUS1PRR1V42V5ACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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