FDA.reportPublic FDA data

Middle Ear 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 17:50:19

Label at a glance#

ProductMiddle Ear Drops 9616
Active ingredientSUS SCROFA EAR
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

Middle ear 12X

QUESTIONS

OTC - QUESTIONS SECTION

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

INDICATIONS & USAGE SECTION

For the temporary relief of minor ear pain, ringing in the ear(s), dizziness, loss of balance, loss of appetite, nasal congestion, nausea, or mild headache.*

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 or vomiting, 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

20% ethanol, purified water.

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Est 1985

Professional Formulas

Complementary Health

Middle Ear Drops

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

Label imageLabel image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-9616-12026-01-08C16284748780-11030e365-2dc2-111a-e063-dadaa90a10e2RERM
63083-9616-12026-01-08C16284748780-11030e365-2dc2-111a-e063-dadaa90a10e2RERM
63083-9616-12024-01-30C16284748780-11030e365-2dc2-111a-e063-dadaa90a10e2RERM
63083-9616-12024-01-30C16284748780-11030e365-2dc2-111a-e063-dadaa90a10e2RERM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-9616-1Middle Ear Drops961629.5 mL in 1 BOTTLE, DROPPERLIQUID29.52

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
63083-961663083-9616-1

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
SUS SCROFA EAR7DX2J287CVACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12019-08-15full-release2026-06-01 02:15:57

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
Middle Ear Drops 9616MIDDLE EAR DROPSProfessional Complementary Health Formulas2b8ff3ca-e52f-4855-938e-b264ad7d33342026-01-08WarningsExact identifier
ndc (package): 63083-9616-1
ndc (product): 63083-9616
ndc11 (package): 63083961601
spl id: 4ef7b112-7147-43d1-85f9-ea25fd03af97
spl set id: 2b8ff3ca-e52f-4855-938e-b264ad7d3334

Reported adverse events (FAERS/openFDA)#

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