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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49580-0383-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49580-0383-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49580-0383-4557ba5c1ecfa…9c80585c8c6e…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1090496Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac21ec89-12a3-4c83-9557-98a964e5d8deAvailable on FDA.report

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

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 196 · 3,909 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4fff664b-4ff0-4007-95ab-cb273807b9b42026-08-25WarningsExact identifier
application number: M012
Vicks Sinex SEVERE CONGESTION MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH464534ee-15f8-3af8-e063-6394a90a3f182026-08-24WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact identifier
application number: M012
Afrin Original NasalOXYMETAZOLINE HYDROCHLORIDEJC World Bell Wholesale Co., Inc.ecfa14b8-a3f3-4569-b489-c9e1a51cf09e2026-08-20WarningsExact identifier
application number: M012
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACKBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCLCVS PHARMACY, INC.4d94968b-ada3-4344-8563-cba7fc491d742026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY, INCfe12f3bd-3237-42d1-aec5-c831b96371752026-08-19WarningsExact identifier
application number: M012
CVS Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INCbfb3d021-f65f-499c-bbb1-c1aceb7a7bf92026-08-19WarningsExact identifier
application number: M012
CVS Long Acting CoughDEXTROMETHORPHAN HBRCVS PHARMACY, INC31a7c0e2-af1c-45dd-8a93-e0879cae60052026-08-19WarningsExact identifier
application number: M012
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLCb3baf939-a9fd-47ac-9bc7-68435e32ea1e2026-08-19WarningsExact identifier
application number: M012
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS PHARMACY5151127a-4d09-413a-a08b-f76fb77e11882026-08-19WarningsExact identifier
application number: M012
CVS DT and NT Combo Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY360c8c62-0945-4031-b291-d40c4270b9402026-08-19WarningsExact identifier
application number: M012
equate childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.24758ab0-ba08-4b4a-9861-449612bdb89c2026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus plus Chest CongestionGUAIFENESINCVS PHARMACY3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
application number: M012
CVS ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY4490a7e1-d5b9-459c-8751-c244868079812026-08-19WarningsExact identifier
application number: M012
CVS DayTime and NightTime Value Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY4c813cd5-2c97-4fc3-926c-1a0396551a312026-08-19WarningsExact identifier
application number: M012

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