FDA.reportPublic FDA data

Tinnitus Formula

Product NDC
83027-0006
11-digit product format
830270006
Labeler code
83027
Product ID
83027-0006_b6fde97d-9326-4d8f-ade3-40658649fd73
Type
HUMAN OTC DRUG
Nonproprietary name
Cimicifuga Racemosa, Ginkgo Biloba, Cinchona Officinalis, Hydrastis Canadensis, Lycopodium Clavatum, Sulphur, Cerebellum (Suis), Ear (Suis) Digitalis Purpurea, Kali Carbonicum
Dosage form
SPRAY
Route
ORAL
Labeler
Nutritional Specialties, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-04-10
Substance
BLACK COHOSH; GINKGO; CINCHONA OFFICINALIS BARK; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SULFUR; SUS SCROFA CEREBRUM; SUS SCROFA EAR; DIGITALIS; POTASSIUM CARBONATE
Active strength
2; 2; 3; 6; 6; 6; 6; 6; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Tinnitus Formula
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BLACK COHOSH2 [hp_X]/mL
GINKGO2 [hp_X]/mL
CINCHONA OFFICINALIS BARK3 [hp_X]/mL
GOLDENSEAL6 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE6 [hp_X]/mL
SULFUR6 [hp_X]/mL
SUS SCROFA CEREBRUM6 [hp_X]/mL
SUS SCROFA EAR6 [hp_X]/mL
DIGITALIS12 [hp_X]/mL
POTASSIUM CARBONATE30 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K73E24S6X9Internal UNII lookup
19FUJ2C58TInternal UNII lookup
S003A158SBInternal UNII lookup
ZW3Z11D0JVInternal UNII lookup
C88X29Y479Internal UNII lookup
70FD1KFU70Internal UNII lookup
4GB5DQR532Internal UNII lookup
7DX2J287CVInternal UNII lookup
F1T8QT9U8BInternal UNII lookup
BQN1B9B9HAInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4885c23c-093c-4ea0-8061-83cdeab9902eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0006-1Tinnitus Formula60 mL in 1 BOTTLE, SPRAYSPRAY602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0006TINNITUS FORMULA (CIMICIFUGA RACEMOSA, GINKGO BILOBA, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, SULPHUR, CEREBELLUM (SUIS), EAR (SUIS) DIGITALIS PURPUREA, KALI CARBONICUM) SPRAY [NUTRITIONAL SPECIALTIES, INC.]1Current NDC, 1 package rows20230411_4885c23c-093c-4ea0-8061-83cdeab9902e.zip

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
Tinnitus FormulaCIMICIFUGA RACEMOSA, GINKGO BILOBA, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, SULPHUR, CEREBELLUM (SUIS), EAR (SUIS) DIGITALIS PURPUREA, KALI CARBONICUMNutritional Specialties, Inc.4885c23c-093c-4ea0-8061-83cdeab9902e2025-10-06WarningsExact identifier
ndc (product): 83027-0006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83027-0006-18302700060160 mL in 1 BOTTLE, SPRAY (83027-0006-1) 60 ml2023-04-10NoNoCurrent