Tinnitus

Product NDC
55714-4857
11-digit product format
557144857
Labeler code
55714
Product ID
55714-4857_10462abf-9261-c0fe-e063-6394a90a7a71
Type
HUMAN OTC DRUG
Nonproprietary name
Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac., Tabacum, Thiosinaminum, Viola odorata
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-01-31
Substance
ACONITUM NAPELLUS; ALLYLTHIOUREA; ANEMONE PULSATILLA; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; DYSPHANIA AMBROSIOIDES; GOLDENSEAL; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; QUININE SULFATE; SALICYLIC ACID; TOBACCO LEAF; VIOLA ODORATA
Active strength
20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20 [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; [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
Pharmacologic classes
Allergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vasodilation [PE], Vegetable Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS20 [hp_X]/mL
ALLYLTHIOUREA20 [hp_X]/mL
ANEMONE PULSATILLA20 [hp_X]/mL
BARIUM CARBONATE20 [hp_X]/mL
BARIUM CHLORIDE DIHYDRATE20 [hp_X]/mL
CAPSICUM20 [hp_X]/mL
CAUSTICUM20 [hp_X]/mL
CINCHONA OFFICINALIS BARK20 [hp_X]/mL
DYSPHANIA AMBROSIOIDES20 [hp_X]/mL
GOLDENSEAL20 [hp_X]/mL
GRAPHITE20 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE20 [hp_X]/mL
NITROGLYCERIN20 [hp_X]/mL
PHOSPHORUS20 [hp_X]/mL
POTASSIUM CHLORIDE20 [hp_X]/mL
POTASSIUM DICHROMATE20 [hp_X]/mL
QUININE SULFATE20 [hp_X]/mL
SALICYLIC ACID20 [hp_X]/mL
TOBACCO LEAF20 [hp_X]/mL
VIOLA ODORATA20 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, 706IDJ14B7, I76KB35JEV, 6P669D8HQ8, EL5GJ3U77E, 00UK7646FG, DD5FO1WKFU, S003A158SB, 4H5RSU087I, ZW3Z11D0JV, 4QQN74LH4O, C88X29Y479, G59M7S0WS3, 27YLU75U4W, 660YQ98I10, T4423S18FM, KF7Z0E0Q2B, O414PZ4LPZ, 6YR2608RSU, AET12U8B74

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4857-1Tinnitus30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4857TINNITUS (ACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATA) LIQUID [NEWTON LABORATORIES, INC.]1Current NDC, 1 package rows20240202_10462aaa-96d4-4ba3-e063-6294a90a7915.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55714-4857-15571448570130 mL in 1 BOTTLE, GLASS (55714-4857-1) 30 ml2024-01-31NoNoCurrent