D-89-1 Eardrops

Manufacturer
DNA Labs, Inc.
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:42:46

Label at a glance#

ProductD-89-1 Eardrops
Active ingredientPLANTAGO MAJOR, UMBILICUS RUPESTRIS, LOBELIA INFLATA, MATRICARIA CHAMOMILLA, ALOE VERA LEAF, CALENDULA ARVENSIS WHOLE, ST. JOHN'S WORT
Label structure7 sections

Dosage and administration

5-10 drops directly into the ear canal as needed or as directed by a health care professional. May also be applied to a cotton ball and inserted into the ear canal. Do not touch dropper to the ear canal.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0162-1

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Plantago Major 1X, Cotyledon Umbilicus 1X, Lobelia Inflata 1X, Chamomilla 1X, Aloe Vera 1X, Calendula 1X, Hypericum 1X

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

Olive oil, garlic oil, mullein oil.

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Ear pain.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

5-10 drops directly into the ear canal as needed or as directed by a health care professional. May also be applied to a cotton ball and inserted into the ear canal. Do not touch dropper to the ear canal.

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of the reach of children.

PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DYNAMIC
NUTRITIONAL
ASSOCIATES, INC.

D-89-1
EAR DROPS

1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label
PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0162-12022-06-06C16284748780-1ba0f9c33-3ada-a910-e053-dadaa90a0b85D-89-1 Eardrops
58264-0162-12021-01-29C16284748780-1ba0f9c33-3ada-a910-e053-dadaa90a0b85D-89-1 Eardrops

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58264-016258264-0162-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
2ce09e67-1f7b-effd-e063-6294a90abb889a48e4fb-8d52-423c-9764-68d42a574aed2025-01-29WarningsExact identifier
spl set id: 9a48e4fb-8d52-423c-9764-68d42a574aed

Reported adverse events (FAERS/openFDA)#

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