MedPath

Ear Ringing

Ear Ringing

Approved
Approval ID

bd7e8335-e367-46ab-a85d-a847fdeaeac1

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 19, 2025

Manufacturers
FDA

King Bio Inc.

DUNS: 617901350

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Arnica montana, Calcarea carbonica, Chenopodium anthelminticum, Chininum salicylicum, Cimicifuga racemosa, Coffea tosta, Kali iodatum, Kalmia latifolia, Magnesia carbonica, Manganum aceticum, Manganum carbonicum, Mercurius vivus, Natrum salicylicum, Salicylicum acidum, Thiosinaminum, Thyroidinum.

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57955-5276
Product Classification
G
Generic Name
Arnica montana, Calcarea carbonica, Chenopodium anthelminticum, Chininum salicylicum, Cimicifuga racemosa, Coffea tosta, Kali iodatum, Kalmia latifolia, Magnesia carbonica, Manganum aceticum, Manganum carbonicum, Mercurius vivus, Natrum salicylicum, Salicylicum acidum, Thiosinaminum, Thyroidinum.
Product Specifications
Route of AdministrationORAL
Effective DateMay 19, 2025
FDA Product Classification

INGREDIENTS (28)

DYSPHANIA AMBROSIOIDES WHOLEActive
Quantity: 10 [hp_X] in 59 mL
Code: 4H5RSU087I
Classification: ACTIB
BLACK COHOSHActive
Quantity: 10 [hp_X] in 59 mL
Code: K73E24S6X9
Classification: ACTIB
COFFEA ARABICA SEED, ROASTEDActive
Quantity: 10 [hp_X] in 59 mL
Code: 9H58JRT35E
Classification: ACTIB
POTASSIUM IODIDEActive
Quantity: 10 [hp_X] in 59 mL
Code: 1C4QK22F9J
Classification: ACTIM
KALMIA LATIFOLIA LEAFActive
Quantity: 10 [hp_X] in 59 mL
Code: 79N6542N18
Classification: ACTIB
MAGNESIUM CARBONATEActive
Quantity: 10 [hp_X] in 59 mL
Code: 0E53J927NA
Classification: ACTIB
SODIUM SALICYLATEActive
Quantity: 10 [hp_X] in 59 mL
Code: WIQ1H85SYP
Classification: ACTIB
SALICYLIC ACIDActive
Quantity: 10 [hp_X] in 59 mL
Code: O414PZ4LPZ
Classification: ACTIB
ALLYLTHIOUREAActive
Quantity: 10 [hp_X] in 59 mL
Code: 706IDJ14B7
Classification: ACTIB
THYROID, UNSPECIFIEDActive
Quantity: 10 [hp_X] in 59 mL
Code: 0B4FDL9I6P
Classification: ACTIB
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CITRUS AURANTIUM FRUIT OILInactive
Code: 59JDQ5VT0T
Classification: IACT
ORANGE PEELInactive
Code: TI9T76XD44
Classification: IACT
CITRUS RETICULATA FRUIT OILInactive
Code: 25P9H3QU5E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
LONICERA JAPONICA FLOWERInactive
Code: 4465L2WS4Y
Classification: IACT
POLYEPSILON-LYSINE (4000 MW)Inactive
Code: WB0M8X4TWR
Classification: IACT
CARYA OVATA BARKInactive
Code: X765CF609L
Classification: IACT
STEVIOLInactive
Code: 4741LYX6RT
Classification: IACT
QUININE SALICYLATEActive
Quantity: 10 [hp_X] in 59 mL
Code: 6DY04L71DR
Classification: ACTIB
ARNICA MONTANA WHOLEActive
Quantity: 10 [hp_X] in 59 mL
Code: O80TY208ZW
Classification: ACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDEActive
Quantity: 10 [hp_X] in 59 mL
Code: 2E32821G6I
Classification: ACTIB
MANGANESE CARBONATEActive
Quantity: 10 [hp_X] in 59 mL
Code: 9ZV57512ZM
Classification: ACTIM
MANGANESE ACETATE TETRAHYDRATEActive
Quantity: 10 [hp_X] in 59 mL
Code: 9TO51D176N
Classification: ACTIB
MERCURYActive
Quantity: 10 [hp_X] in 59 mL
Code: FXS1BY2PGL
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/5/2022

image description Ear Ringing.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/5/2022

Uses

Uses for symptomatic relief of ear sounds:

Buzzing

Roaring

Ringing

Whistling

Sensitivity to noise

† as per various homeopathic materia medicas. Claims based
on traditional homeopathic practice, not accepted medical
evidence. These uses have not been evaluated by the FDA,
and product has not been clinically tested.

Reference image:Ear Ringing.jpg

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/5/2022

Directions

Initially, depress pump until
primed.

Spray one dose directly into
mouth.

Adults: 3 sprays 3 times per
day.

Children ages 6-12: 2 sprays 3
times per day.

Consult a physician for use in
children under 6 years of age.

Use additionally as needed, up
to 6 times per day.

Reference image:Ear Ringing.jpg

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 12/5/2022

Other information

Tamper resistant for your protection.

Use only if safety seal is intact.

Keep carton for complete drug facts and product information.

Questions? Call 866.298.2740

King Bio, Inc. 3 Westside Drive

Asheville, NC 2806 USA

FDA Reg. #1053442

For latest product information and instructions: www.DrKings.com

Reference image:Ear Ringing.jpg

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/5/2022

Inactive Ingredients

Citrus Extract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extact, demineralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified Water, Shagbark Hickory (Carya Ovata) Bark Extract, Steviol (Steviol Glycosides).

Reference image:Ear Ringing.jpg

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/5/2022

Active ingredients

Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM
potencies.

Arnica montana, Calcarea carbonica, Chenopodium anthelminticum, Chininum salicylicum, Cimicifuga racemosa, Coffea tosta, Kali iodatum, Kalmia latifolia, Magnesia carbonica, Manganum aceticum, Manganum carbonicum, Mercurius vivus, Natrum salicylicum, Salicylicum acidum, Thiosinaminum, Thyroidinum.

HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

Reference image:Ear Ringing.jpg

WARNINGS SECTION

LOINC: 34071-1Updated: 12/5/2022

Warnings

Stop use and consult a physician** if** symptoms worsen or
persist for more than 7 days.

If pregnant or breast-feeding, ask a healthcare professional
before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Reference image:Ear Ringing.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/5/2022

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Reference image:Ear Ringing.jpg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/5/2022

Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM
potencies.

Arnica montana .......................................................dull hearing
Calcarea carbonica ............................................ cracking in ears
Chenopodium anthelminticum.......................auditory nerve issues
Chininum salicylicum..................................................ear ringing
Cimicifuga racemosa............................................noise sensitivity
Coffea tosta .............................................ringing, roaring in ears
Kali iodatum..................................................................ear pain
Kalmia latifolia .......................................................stiches in ear
Magnesia carbonica ........................................diminished hearing
Manganum aceticum ....................................................whistling
Manganum carbonicum...................................................earache
Mercurius vivus .......................................tinkling, buzzing sounds
Natrum salicylicum ................................................noises in ears
Salicylicum acidum........................................................deafness
Thiosinaminum ...................................................vertigo, tinnitus
Thyroidinum...........................................................ear disorders

**“HPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States.

Reference image:Ear Ringing.jpg

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Ear Ringing - FDA Drug Approval Details