FDA.reportPublic FDA data

Tinnitus Control

Product NDC
50845-0130
11-digit product format
508450130
Labeler code
50845
Product ID
50845-0130_cb203ef3-d0f7-41ec-a37f-6313c71c7a3f
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica montana, Chininum sulphuricum, Ferrum metallicum, Kali phosphoricum, Natrum sulphuricum, Pulsatilla, Silicea, Thiosinaminum,
Dosage form
SPRAY
Route
ORAL
Labeler
Liddell Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2011-04-26
Marketing end
2026-06-30
Substance
ALLYLTHIOUREA; ARNICA MONTANA; IRON; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; QUININE SULFATE; SILICON DIOXIDE; SODIUM SULFATE
Active strength
30; 30; 30; 30; 30; 30; 30; 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
Pharmacologic classes
Antimalarial [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tinnitus Control

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLYLTHIOUREA30 [hp_X]/mL
ARNICA MONTANA30 [hp_X]/mL
IRON30 [hp_X]/mL
POTASSIUM PHOSPHATE, DIBASIC30 [hp_X]/mL
PULSATILLA VULGARIS30 [hp_X]/mL
QUININE SULFATE30 [hp_X]/mL
SILICON DIOXIDE30 [hp_X]/mL
SODIUM SULFATE30 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii706IDJ14B7, O80TY208ZW, E1UOL152H7, CI71S98N1Z, I76KB35JEV, KF7Z0E0Q2B, ETJ7Z6XBU4, 0YPR65R21J

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
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87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50845-0130-12019-10-29C16284748780-1960f7f55-c35f-8e05-e053-dbdaa90a074aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0130-1Tinnitus Control30 mL in 1 BOTTLE, SPRAYSPRAY302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLYLTHIOUREAACTIVE INGREDIENT706IDJ14B7TINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWTINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1
IRONACTIVE INGREDIENTE1UOL152H7TINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1ZTINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEVTINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1
QUININE SULFATEACTIVE INGREDIENTKF7Z0E0Q2BTINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU4TINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21JTINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1
ALLYLTHIOUREAACTIVE MOIETY706IDJ14B7TINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1
ARNICA MONTANAACTIVE MOIETYO80TY208ZWTINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1
IRONACTIVE MOIETYE1UOL152H7TINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1
POTASSIUM CATIONACTIVE MOIETY295O53K152TINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEVTINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1
QUININEACTIVE MOIETYA7V27PHC7ATINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU4TINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37TINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MTINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0130TINNITUS CONTROL (ARNICA MONTANA, CHININUM SULPHURICUM, FERRUM METALLICUM, KALI PHOSPHORICUM, NATRUM SULPHURICUM, PULSATILLA, SILICEA, THIOSINAMINUM,) SPRAY [LIDDELL LABORATORIES, INC.]1Current NDC, Legacy NDC, 1 package rows20110428_a617e58b-1793-401d-b1ec-d419932ff897.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50845-0130-15084501300130 mL in 1 BOTTLE, SPRAY (50845-0130-1) 30 ml2011-04-262026-06-30NoNoHistorical