FDA.reportPublic FDA data

Otitis Media Drops

Manufacturer
Professional Complementary Health Formulas | Natural Pharmaceutical Manufacturing LLC
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:50:26

Label at a glance#

ProductOtitis Media Drops 2153
Active ingredientOYSTER SHELL CALCIUM CARBONATE, CRUDE, PULSATILLA MONTANA WHOLE, ACONITUM NAPELLUS WHOLE, SUS SCROFA EAR, AMARYLLIS BELLADONNA WHOLE, TELLURIUM, FERROSOFERRIC PHOSPHATE, GELSEMIUM SEMPERVIRENS ROOT, MERCURY, STREPTOCOCCUS PNEUMONIAE, HAEMOPHILUS INFLUENZAE
Label structure9 sections

Dosage and administration

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Calcarea carbonica 3X
Pulsatilla 4X, 12X, 30X
Aconitum napellus 6X
Ear 6X, 60X, 100X, 200X
Belladonna 12X
Tellurium metallicum 12X
Ferrum phosphoricum 12X, 30X
Gelsemium sempervirens 30X
Mercurius vivus 30X
Streptococcus pneumoniae 30X
Haemophilus influenzae 60X

QUESTIONS

OTC - QUESTIONS SECTION

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

INDICATIONS & USAGE SECTION

For the temporary relief of minor earache or ringing in the ears.*

OTC - PURPOSE SECTION

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

WARNINGS

WARNINGS SECTION

Persistent symptoms may be a sign of a serious condition. If symptoms persist or are accompanied by a fever, persistent headache, or loss of hearing, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a healthcare professional before use.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

10% ethanol, purified water, 8% vegetable glycerin (from soy).

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Est 1985

Professional Formulas

Complementary Health

Otitis Media Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

Label imageLabel image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-2153-22026-01-08C16284748780-11030e365-26bd-111a-e063-dadaa90a10e2C153
63083-2153-22026-01-08C16284748780-11030e365-26bd-111a-e063-dadaa90a10e2C153
63083-2153-22024-01-30C16284748780-11030e365-26bd-111a-e063-dadaa90a10e2C153
63083-2153-22024-01-30C16284748780-11030e365-26bd-111a-e063-dadaa90a10e2C153

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-2153-2Otitis Media Drops215359 mL in 1 BOTTLE, DROPPERLIQUID592

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
63083-215363083-2153-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
PULSATILLA MONTANA WHOLE24K790T39BACTIB
ACONITUM NAPELLUS WHOLEU0NQ8555JDACTIB
SUS SCROFA EAR7DX2J287CVACTIB
AMARYLLIS BELLADONNA WHOLE11B89M58UNACTIB
TELLURIUMNQA0O090ZJACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
MERCURYFXS1BY2PGLACTIB
STREPTOCOCCUS PNEUMONIAEBT6U234YR2ACTIB
HAEMOPHILUS INFLUENZAEK738E2MB3IACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12019-08-15full-release2026-06-01 02:16:34

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
Otitis Media Drops 2153OTITIS MEDIA DROPSProfessional Complementary Health Formulas9e8b60e9-0bd7-4c6c-99fa-cb87a9c831722026-01-08WarningsExact identifier
ndc (package): 63083-2153-2
ndc (product): 63083-2153
ndc11 (package): 63083215302
spl id: 01edc603-bccd-4047-a651-145796e5cf51
spl set id: 9e8b60e9-0bd7-4c6c-99fa-cb87a9c83172

Reported adverse events (FAERS/openFDA)#

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