Tussin Long Acting Cough

Product NDC
49580-0383
11-digit product format
495800383
Labeler code
49580
Product ID
49580-0383_33a40dda-c597-4e8b-8195-97c527982fdd
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr
Dosage form
LIQUID
Route
ORAL
Labeler
P & L Development, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-08-31
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/10mL
Pharmacologic classes
Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tussin Long Acting Cough
Brand name suffix
READYINCASE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui1090496

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49580-0383-4Tussin Long Acting CoughREADYINCASE118 mL in 1 BOTTLE, PLASTICLIQUID1189
49580-0383-4Tussin Long Acting CoughREADYINCASE1 in 1 BOXLIQUID19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSIN LONG ACTING COUGH READYINCASE (DEXTROMETHORPHAN HBR) LIQUID [P & L DEVELOPMENT, LLC]4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSIN LONG ACTING COUGH READYINCASE (DEXTROMETHORPHAN HBR) LIQUID [P & L DEVELOPMENT, LLC]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MTUSSIN LONG ACTING COUGH READYINCASE (DEXTROMETHORPHAN HBR) LIQUID [P & L DEVELOPMENT, LLC]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUSSIN LONG ACTING COUGH READYINCASE (DEXTROMETHORPHAN HBR) LIQUID [P & L DEVELOPMENT, LLC]4
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2TUSSIN LONG ACTING COUGH READYINCASE (DEXTROMETHORPHAN HBR) LIQUID [P & L DEVELOPMENT, LLC]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN LONG ACTING COUGH READYINCASE (DEXTROMETHORPHAN HBR) LIQUID [P & L DEVELOPMENT, LLC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN LONG ACTING COUGH READYINCASE (DEXTROMETHORPHAN HBR) LIQUID [P & L DEVELOPMENT, LLC]4
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STUSSIN LONG ACTING COUGH READYINCASE (DEXTROMETHORPHAN HBR) LIQUID [P & L DEVELOPMENT, LLC]4
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3ATUSSIN LONG ACTING COUGH READYINCASE (DEXTROMETHORPHAN HBR) LIQUID [P & L DEVELOPMENT, LLC]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTUSSIN LONG ACTING COUGH READYINCASE (DEXTROMETHORPHAN HBR) LIQUID [P & L DEVELOPMENT, LLC]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN LONG ACTING COUGH READYINCASE (DEXTROMETHORPHAN HBR) LIQUID [P & L DEVELOPMENT, LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN LONG ACTING COUGH READYINCASE (DEXTROMETHORPHAN HBR) LIQUID [P & L DEVELOPMENT, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0383TUSSIN LONG ACTING COUGH READYINCASE (DEXTROMETHORPHAN HBR) LIQUID [P & L DEVELOPMENT, LLC]9Current NDC, Legacy NDC, 2 package rows20241212_ac21ec89-12a3-4c83-9557-98a964e5d8de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090496dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSNac21ec89-12a3-4c83-9557-98a964e5d8de9
1090496dextromethorphan hydrobromide 3 MG/ML Oral SolutionSCDac21ec89-12a3-4c83-9557-98a964e5d8de9
1090496dextromethorphan hydrobromide 15 MG per 5 ML Oral SolutionSYac21ec89-12a3-4c83-9557-98a964e5d8de9
1090496dextromethorphan hydrobromide 30 MG per 10 ML Oral SolutionSYac21ec89-12a3-4c83-9557-98a964e5d8de9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49580-0383-4495800383041 BOTTLE, PLASTIC in 1 BOX (49580-0383-4) / 118 mL in 1 BOTTLE, PLASTIC2014-08-312022-12-30NoNoCurrent