FDA.reportPublic FDA data

SYMBIOPATHIC

Manufacturer
Symbiopathic | Biological Health Group Corporation
Effective date
2023-08-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:22:00

Label at a glance#

ProductSYMBIOPATHIC
Active ingredientMYCOBACTERIUM PHLEI
Label structure10 sections

Dosage and administration

5-10 drops, three times daily.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Mycobacterium Phlei 6X

WARNINGS:

WARNINGS SECTION

If symptoms persist more than a few days, contact a licensed practitioner. As with any drug, if you are
pregnant or nursing, seek the advice of a health care professional before using this product. Keep this and all medications out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Protect from light and heat.

Tamper Evident
Do not use product if the tamper evident strip is broken
or removed from the base of the cap.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

5-10 drops, three times daily.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Purified water, sodium chloride

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN:In case of overdose, get medical help or call a Poison Control Center right away.

INDICATIONS:

INDICATIONS & USAGE SECTION

Acts as a strong immune modulator in conditions of the respiratory tract, extra pulmonary tuberculosis and lungs.
Also for fever and conditions of weakness.

PURPOSE:

OTC - PURPOSE SECTION

For internal indications according to traditional homeopathic practice.

OTHER INFORMATION:

SPL UNCLASSIFIED SECTION

Protect from light and heat.

For professional distribution only.

*These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 10MlLabel 10Ml

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69711-255-102024-07-30C16284748780-11030e365-037d-111a-e063-dadaa90a10e2Symbio Cere
69711-255-102024-01-30C16284748780-11030e365-037d-111a-e063-dadaa90a10e2Symbio Cere

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69711-255-10SYMBIOPATHIC1 in 1 CARTONLIQUID11
69711-255-10SYMBIOPATHIC10 mL in 1 BOTTLELIQUID101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69711-255SYMBIOPATHIC (SYMBIO MYCO PHLEI DROPS 6X) LIQUID [SYMBIOPATHIC]12 package rows20230815_02eb2683-7320-64e4-e063-6394a90a4355.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69711-25569711-255-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
MYCOBACTERIUM PHLEIT67520T45FACTIB

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
02eb2676-2ef2-1a92-e063-6294a90a3a0a02eb2683-7320-64e4-e063-6394a90a43552023-08-10WarningsExact identifier
spl id: 02eb2676-2ef2-1a92-e063-6294a90a3a0a
spl set id: 02eb2683-7320-64e4-e063-6394a90a4355

Reported adverse events (FAERS/openFDA)#

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