FDA.reportPublic FDA data

BOLYM-EX Drops

Manufacturer
BioResource Inc. | PEKANA Naturheilmittel GmbH
Effective date
2015-06-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:31:42

Label at a glance#

ProductBOLYM-EX Drops
Active ingredientBenzoic Acid, Formic Acid, Aristolochia Clematitis Root, Asafetida, Avena Sativa Flowering Top, Berberis Vulgaris Root Bark, Calcium Phosphate, Capsella bursa-pastoris, Galium aparine, Daphne Mezereum Bark, Piper Methysticum Root
Label structure9 sections

Storage and handling

Protect from light and heat.

Label contents#

Full prescribing information#

Ingredients

OTC - ACTIVE INGREDIENT SECTION

Acidum benzoicum5X
Acidum formicicum5X
Aristolochia clematitis24X
Asa foetida5X
Avena sativa4X
Berberis vulgaris5X
Calcium phosphoricum8X
Capsella bursa-pastoris5X
Galium aparine5X
Daphne mezereum (Mezereum)8X
Piper methysticum10X

Selected ingredients prepared by spagyric processes.

INACTIVE INGREDIENT SECTION

Contains 18% alcohol by volume.

Indications

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

For minor symptoms related to tick-borne illness.

Dosage

DOSAGE & ADMINISTRATION SECTION

Unless otherwise prescribed, adults take 17 drops in water or herbal tea, 3-4 times per day, at least 15 minutes before meals. For pediatric dosages, consult your practitioner.

Warning

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

If symptoms persist, contact a licensed practitioner.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

STORAGE AND HANDLING SECTION

Protect from light and heat.

Tamper Evident

OTC - DO NOT USE SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:
BioResource Inc.
Cotati, CA 94931

Manufactured by:
PEKANA® GmbH
D-88353 Kisslegg

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOLYM-EX™
Oral Drops

Homeopathic Medicine

For minor symptoms related
to tick-borne illness

1.7 FL OZ
(50 ml)

PEKANA®

Principal Display Panel - 50 ml Bottle Carton
Principal Display Panel - 50 ml Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54256-201-102025-01-23C16284748780-19d75b9d0-9f6d-f424-e053-dadaa90a57ceBOLYM-EX™ Oral Drops
54256-201-102020-01-31C16284748780-19d75b9d0-9f6d-f424-e053-dadaa90a57ceBOLYM-EX™ Oral Drops

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aristolochia Clematitis RootACTIVE INGREDIENTZY0NX0W00D1
AsafetidaACTIVE INGREDIENTW9FZA51AS11
Avena Sativa Flowering TopACTIVE INGREDIENTMA9CQJ3F7F1
Benzoic AcidACTIVE INGREDIENT8SKN0B0MIM1
Berberis Vulgaris Root BarkACTIVE INGREDIENT1TH8Q20J0U1
Calcium PhosphateACTIVE INGREDIENT97Z1WI3NDX1
Capsella bursa-pastorisACTIVE INGREDIENTW0X9457M591
Daphne Mezereum BarkACTIVE INGREDIENTX2N6E405GV1
Formic AcidACTIVE INGREDIENT0YIW783RG11
Galium aparineACTIVE INGREDIENTZ4B65614881
Piper Methysticum RootACTIVE INGREDIENTBOW48C81XP1
Aristolochia Clematitis RootACTIVE MOIETYZY0NX0W00D1
AsafetidaACTIVE MOIETYW9FZA51AS11
Avena Sativa Flowering TopACTIVE MOIETYMA9CQJ3F7F1
Benzoic AcidACTIVE MOIETY8SKN0B0MIM1
Berberis Vulgaris Root BarkACTIVE MOIETY1TH8Q20J0U1
Calcium CationACTIVE MOIETY2M83C4R6ZB1
Capsella bursa-pastorisACTIVE MOIETYW0X9457M591
Daphne Mezereum BarkACTIVE MOIETYX2N6E405GV1
Formic AcidACTIVE MOIETY0YIW783RG11
Galium aparineACTIVE MOIETYZ4B65614881
Piper Methysticum RootACTIVE MOIETYBOW48C81XP1
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54256-20154256-201-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzoic Acid8SKN0B0MIMACTIB
Formic Acid0YIW783RG1ACTIB
Aristolochia Clematitis RootZY0NX0W00DACTIB
AsafetidaW9FZA51AS1ACTIB
Avena Sativa Flowering TopMA9CQJ3F7FACTIB
Berberis Vulgaris Root Bark1TH8Q20J0UACTIB
Calcium Phosphate97Z1WI3NDXACTIB
Capsella bursa-pastorisW0X9457M59ACTIB
Galium aparineZ4B6561488ACTIB
Daphne Mezereum BarkX2N6E405GVACTIB
Piper Methysticum RootBOW48C81XPACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
ab0ba85c-d426-48ba-ad69-11cb42d279a9ea212dad-3b8e-4643-b853-59a44c25357d2025-01-22WarningsExact identifier
spl set id: ea212dad-3b8e-4643-b853-59a44c25357d

Reported adverse events (FAERS/openFDA)#

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