FDA.reportPublic FDA data

Otoflam

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-10-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:28:35

Label at a glance#

ProductOtoflam HP
Active ingredientATROPA BELLADONNA WHOLE, CONIUM MACULATUM FLOWERING TOP, SOLANUM DULCAMARA TOP, FERROSOFERRIC PHOSPHATE, CALCIUM SULFIDE, POTASSIUM DICHROMATE, MERCURIUS SOLUBILIS, PULSATILLA PRATENSIS WHOLE, SILICON DIOXIDE, MATRICARIA CHAMOMILLA WHOLE
Label structure9 sections

Indications and uses

May temporarily relieve ear pain and swelling.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 4 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 10% of Belladonna 30X, Chamomilla 30C, Conium Maculatum 30X, Dulcamara 30X, Ferrum Phosphoricum 30X, Hepar Sulphuris Calcareum 30X, Kali Bichromicum 30X, Mercurius Solubilis 30X, Pulsatilla 30X, Silicea 30X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve ear pain and swelling.**

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

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health 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

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 4 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS AND USAGE:

INDICATIONS & USAGE SECTION

May temporarily relieve ear pain and swelling.**

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579

800-869-8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

OTOFLAM HP

1 fl. oz. (30 ml)

Otoflam HPOtoflam HP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0513-12024-10-29C16284748780-1ba0f9c33-340b-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0513-12023-01-30C16284748780-1ba0f9c33-340b-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0513-12021-09-01C16284748780-1ba0f9c33-340b-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0513-12021-01-29C16284748780-1ba0f9c33-340b-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0513-1OtoflamHP30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0513OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SILICEA, CHAMOMILLA.) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20241031_76c6b494-43d1-4508-bea4-4f9026b4a5fa.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-051344911-0513-1

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
ATROPA BELLADONNA WHOLEDSV74G1P2JACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
PULSATILLA PRATENSIS WHOLE8E272251DIACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SILICEA, CHAMOMILLA.Energique, Inc.76c6b494-43d1-4508-bea4-4f9026b4a5fa2024-10-29WarningsExact identifier
ndc (package): 44911-0513-1
ndc (product): 44911-0513
ndc11 (package): 44911051301
spl id: b1b1bae2-148d-43f0-a7fe-f35c19a1bd31
spl set id: 76c6b494-43d1-4508-bea4-4f9026b4a5fa

Reported adverse events (FAERS/openFDA)#

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