Ear

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2026-03-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:38:03

Label at a glance#

ProductEar
Active ingredientBAPTISIA TINCTORIA ROOT, ECHINACEA ANGUSTIFOLIA WHOLE, PHYTOLACCA AMERICANA ROOT, GOLDENSEAL, CAPSICUM, MATRICARIA CHAMOMILLA WHOLE, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, PLANTAGO MAJOR WHOLE, PULSATILLA PRATENSIS WHOLE
Label structure9 sections

Indications and uses

For temporary relief of earache with soreness, sticking pain in ears, and minor swelling of the ear with redness.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• 10 drops orally, 3 times a day or as directed by a health care professional. • Consult a health care professional for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Baptisia Tinctoria 3X, Capsicum Annuum 12X, Chamomilla 12X, Echinacea (Angustifolia) 3X, Ferrum Phosphoricum 12X, Hydrastis Canadensis 5X, Kali Muriaticum 12X, Phytolacca Decandra 4X, Plantago Major 12X, Pulsatilla (Pratensis) 12X.

PURPOSE:

OTC - PURPOSE SECTION

Baptisia Tinctoria - weakness,** Capsicum Annuum - weakness,** Chamomilla - irritability,** Echinacea (Angustifolia) - headache,** Ferrum Phosphoricum – throbbing pain,** Hydrastis Canadensis – sore throat,** Kali Muriaticum – congested ear,** Phytolacca Decandra - fever,** Plantago Major – pain in ear,** Pulsatilla (Pratensis) – ear discomfort**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

INDICATIONS & USAGE SECTION

For temporary relief of earache with soreness, sticking pain in ears, and minor swelling of the ear with redness.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

Sore Throat Warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.

If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is broken or missing.
Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• 10 drops orally, 3 times a day or as directed by a health care professional.

• Consult a health care professional for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

1-800-288-9525

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional
EAR
HOMEOPATHIC
1 fl. oz. (30 mL)

EAREAR

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130210184341626GTIN-13: 0210184341626
EAN-13: 0210184341626
GTIN-12: 210184341626
UPC-A: 210184341626
GTIN storage (14 digits): 00210184341626
BANI59 Ear 1-27-26.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
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9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
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9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
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7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0539-12024-01-05C16284748780-1ba0f9c33-2929-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0539-12021-01-29C16284748780-1ba0f9c33-2929-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0539-1Ear30 mL in 1 BOTTLE, DROPPERLIQUID303

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-053943857-0539-1

Ingredients#

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

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

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
EarBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, CAPSICUM ANNUUM, CHAMOMILLA, FERRUM PHOSPHORICUM, KALI MURIATICUM, PLANTAGO MAJOR, PULSATILLA (PRATENSIS)BioActive Nutritional, Inc.82774eed-a906-4a19-86d9-05ea1462bd612026-03-18WarningsExact identifier
ndc (package): 43857-0539-1
ndc (product): 43857-0539
ndc11 (package): 43857053901
spl id: 64379f2e-0201-42b6-924d-a8d1ee244531
spl set id: 82774eed-a906-4a19-86d9-05ea1462bd61

Reported adverse events (FAERS/openFDA)#

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