EAR RX

Manufacturer
Miami Beach Pediatrics pa
Effective date
2021-12-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:15:26

Label at a glance#

ProductEAR RX
Active ingredientACONITUM NAPELLUS, BARIUM CARBONATE, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAPSICUM, ACTIVATED CHARCOAL, CAUSTICUM, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, CALCIUM SULFIDE, POTASSIUM CHLORIDE, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, SODIUM CHLORIDE, PLANTAGO MAJOR, PULSATILLA VULGARIS, SILICON DIOXIDE, SULFUR, VERBASCUM THAPSUS
Label structure8 sections

Indications and uses

Temporarily relieves inflammation and pain in the ear from infection.

Dosage and administration

Shake well and take 5 drops under tongue 3 times a day for 10 days. Take at least 15 minutes away from eating or drinking.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS (HPUS*):

OTC - ACTIVE INGREDIENT SECTION

Equal amounts of: Aconitum nap 6X, Baryta carb 10X, Belladonna 9X, Calc carb 6X, Capsicum 9X, Carbo veg 12X, Causticum 8X, Chamomilla 9X, Ferrum phos 9X, Hepar sulph calc 10X, Kali mur 10X, Lachesis 8X, Lycopodium 6X, Mercurius sol 12X, Natrum mur 6X, Plantago 9X, Pulsatilla 9X, Silicea 9X, Sulphur 6X, Verbascum 6X.

SPL UNCLASSIFIED SECTION

*The letters "HPUS" indicate the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

USES:

INDICATIONS & USAGE SECTION

Temporarily relieves inflammation and pain in the ear from infection.

WARNINGS:

WARNINGS SECTION

  • This product is to be used under the supervision of your healthcare provider.
  • If symptoms worsen or persist for more than 5 days, consult your practitioner.
  • IF PREGNANT OR NURSING, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • KEEP OUT OF THE REACH OF CHILDREN.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Shake well and take 5 drops under tongue 3 times a day for 10 days. Take at least 15 minutes away from eating or drinking.

OTHER INFORMATION:

OTHER SAFETY INFORMATION

Do not use if cap seal is broken. Store in a cool, dry place.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Citric Acid, Potassium Sorbate, Purified Water, Vegetable Glycerin.

QUESTIONS or COMMENTS?

OTC - QUESTIONS SECTION

Miami Beach Pediatrics

975 41st Street, Suite #408

Miami Beach, FL 33140

Tel: 305-672-7337

www.miamibeachpediatrics.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 69390-001-01

Dr. Eisenberg's

EAR RX

Ear Infections

HOMEOPATHIC MEDICINE

1 fl oz (30 mL)

MIAMI BEACH PEDIATRICS

CENTER FOR INTEGRATIVE MEDICINE

1oz bottle label1oz bottle label

OTC - PURPOSE SECTION

Ear Infections

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
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cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69390-001-01EAR RX30 mL in 1 BOTTLE, DROPPERLIQUID305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69390-001EAR RX (ACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUM) LIQUID [MIAMI BEACH PEDIATRICS PA]5Current NDC, Legacy NDC, 1 package rows20211230_a8753f88-4b8a-472f-a4bd-f2e9cec83610.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD1
ACTIVATED CHARCOALACTIVE INGREDIENT2P3VWU3H101
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
BARIUM CARBONATEACTIVE INGREDIENT6P669D8HQ81
CALCIUM SULFIDEACTIVE INGREDIENT1MBW07J51Q1
CAPSICUMACTIVE INGREDIENT00UK7646FG1
CAUSTICUMACTIVE INGREDIENTDD5FO1WKFU1
FERROSOFERRIC PHOSPHATEACTIVE INGREDIENT91GQH8I5F71
LACHESIS MUTA VENOMACTIVE INGREDIENTVSW71SS07I1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ1
MERCURIUS SOLUBILISACTIVE INGREDIENT324Y4038G21
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6I1
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6U1
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I101
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X1
SULFURACTIVE INGREDIENT70FD1KFU701
VERBASCUM THAPSUSACTIVE INGREDIENTC9TD27U1721
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD1
ACTIVATED CHARCOALACTIVE MOIETY2P3VWU3H101
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
BARIUM CATIONACTIVE MOIETYV645272HLN1
CALCIUM SULFIDEACTIVE MOIETY1MBW07J51Q1
CAPSICUMACTIVE MOIETY00UK7646FG1
CAUSTICUMACTIVE MOIETYDD5FO1WKFU1
FERROSOFERRIC PHOSPHATEACTIVE MOIETY91GQH8I5F71
LACHESIS MUTA VENOMACTIVE MOIETYVSW71SS07I1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ1
MERCURIUS SOLUBILISACTIVE MOIETY324Y4038G21
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6I1
PLANTAGO MAJORACTIVE MOIETYW2469WNO6U1
POTASSIUM CATIONACTIVE MOIETY295O53K1521
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
SODIUM CATIONACTIVE MOIETYLYR4M0NH371
SULFURACTIVE MOIETY70FD1KFU701
VERBASCUM THAPSUSACTIVE MOIETYC9TD27U1721
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69390-00169390-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION / ORAL1000 mg/15mlExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CAPSULE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4GRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CAPSULE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION / ORAL1000 mg/15mlExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4POWDER, FOR SUSPENSION / ORAL19 mgExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, COATED / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4PASTE / ORAL48 mgExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SUSPENSION / ORAL400 mgExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, FILM COATED, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CONCENTRATE / ORAL1 mgExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, COATED / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SUSPENSION / ORAL400 mgExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4PASTE / ORAL48 mgExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CONCENTRATE / ORAL1 mgExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET / ORAL6 mgExact identifier — unii+route
24 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET / ORAL6 mgExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4POWDER, FOR SUSPENSION / ORAL19 mgExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4GRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii+route
24 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, FILM COATED, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii+route
24 equally ranked IID candidates

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
EAR RXACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUMMiami Beach Pediatrics paa8753f88-4b8a-472f-a4bd-f2e9cec836102021-12-29WarningsExact identifier
ndc (package): 69390-001-01
ndc (product): 69390-001
ndc11 (package): 69390000101
spl id: d44a9ea9-4e01-ec6c-e053-2a95a90a2bd5
spl set id: a8753f88-4b8a-472f-a4bd-f2e9cec83610

Reported adverse events (FAERS/openFDA)#

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