Ear Ringing

Product NDC
57955-9978
11-digit product format
579559978
Labeler code
57955
Product ID
57955-9978_4cbd2be4-23e5-4103-af78-8aa5c2ae34a4
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica montana, Calcarea carbonica, Chenopodium anth, Chininum salicylicum, Cimicifuga racemosa, Coffea tosta, Kali iodatum, Kalmia latifolia, Magnesia carbonica, Manganum aceticum, Manganum carbonicum, Mercurius vivus, Natrum salicylicum, Salicylicum acidum, Thiosinaminum, and Thyroidinum.
Dosage form
LIQUID
Route
ORAL
Labeler
King Bio Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-03-15
Substance
ALLYLTHIOUREA; ARNICA MONTANA WHOLE; BLACK COHOSH; COFFEA ARABICA SEED, ROASTED; DYSPHANIA AMBROSIOIDES WHOLE; KALMIA LATIFOLIA LEAF; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; MANGANESE CARBONATE; MERCURY; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM IODIDE; QUININE SALICYLATE; SALICYLIC ACID; SODIUM SALICYLATE; THYROID, UNSPECIFIED
Active strength
10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
Pharmacologic classes
Magnetic Resonance Contrast Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC], Paramagnetic Contrast Agent [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ear Ringing
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA WHOLE10 [hp_X]/59mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]/59mL
DYSPHANIA AMBROSIOIDES WHOLE10 [hp_X]/59mL
QUININE SALICYLATE10 [hp_X]/59mL
BLACK COHOSH10 [hp_X]/59mL
COFFEA ARABICA SEED, ROASTED10 [hp_X]/59mL
POTASSIUM IODIDE10 [hp_X]/59mL
KALMIA LATIFOLIA LEAF10 [hp_X]/59mL
MAGNESIUM CARBONATE10 [hp_X]/59mL
MANGANESE ACETATE TETRAHYDRATE10 [hp_X]/59mL
MANGANESE CARBONATE10 [hp_X]/59mL
MERCURY10 [hp_X]/59mL
SODIUM SALICYLATE10 [hp_X]/59mL
SALICYLIC ACID10 [hp_X]/59mL
ALLYLTHIOUREA10 [hp_X]/59mL
THYROID, UNSPECIFIED10 [hp_X]/59mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O80TY208ZWInternal UNII lookup
2E32821G6IInternal UNII lookup
4H5RSU087IInternal UNII lookup
6DY04L71DRInternal UNII lookup
K73E24S6X9Internal UNII lookup
9H58JRT35EInternal UNII lookup
1C4QK22F9JInternal UNII lookup
79N6542N18Internal UNII lookup
0E53J927NAInternal UNII lookup
9TO51D176NInternal UNII lookup
9ZV57512ZMInternal UNII lookup
FXS1BY2PGLInternal UNII lookup
WIQ1H85SYPInternal UNII lookup
O414PZ4LPZInternal UNII lookup
706IDJ14B7Internal UNII lookup
0B4FDL9I6PInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4227b9a3-b0c1-4c74-9edd-922e32e6e89dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-9978-2Ear Ringing59 mL in 1 BOTTLE, SPRAYLIQUID591

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 RingingARNICA MONTANA, CALCAREA CARBONICA, CHENOPODIUM ANTH, CHININUM SALICYLICUM, CIMICIFUGA RACEMOSA, COFFEA TOSTA, KALI IODATUM, KALMIA LATIFOLIA, MAGNESIA CARBONICA, MANGANUM ACETICUM, MANGANUM CARBONICUM, MERCURIUS VIVUS, NATRUM SALICYLICUM, SALICYLICUM ACIDUM, THIOSINAMINUM, AND THYROIDINUM.King Bio Inc.4227b9a3-b0c1-4c74-9edd-922e32e6e89d2026-03-04WarningsExact identifier
ndc (product): 57955-9978

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57955-9978-25795599780259 mL in 1 BOTTLE, SPRAY (57955-9978-2) 59 ml2026-03-15NoNoCurrent