FDA.reportPublic FDA data

Tussi Pres B

Product NDC
52083-237
11-digit product format
520830237
Labeler code
52083
Product ID
52083-237_d5487434-8196-490e-90f9-ce09ce43c65d
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
KRAMER NOVIS
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-03-29
Substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
4; 20; 10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tussi Pres B
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMPHENIRAMINE MALEATE4 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIXA7C9ZN03, 9D2RTI9KYH, 04JA59TNSJ
Rxcui1148155

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52083-237-012025-11-18C16284748780-12cef2736-97e9-d83d-e063-dadaa90ab31fTUSSI PRES- B
52083-237-042025-11-18C16284748780-12cef2736-97e9-d83d-e063-dadaa90ab31fTUSSI PRES- B
52083-237-162025-11-18C16284748780-12cef2736-97e9-d83d-e063-dadaa90ab31fTUSSI PRES- B
52083-237-012025-01-30C16284748780-12cef2736-97e9-d83d-e063-dadaa90ab31fTUSSI PRES- B
52083-237-042025-01-30C16284748780-12cef2736-97e9-d83d-e063-dadaa90ab31fTUSSI PRES- B
52083-237-162025-01-30C16284748780-12cef2736-97e9-d83d-e063-dadaa90ab31fTUSSI PRES- B

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-237-01Tussi Pres B30 mL in 1 BOTTLESYRUP305
52083-237-04Tussi Pres B120 mL in 1 BOTTLESYRUP1205
52083-237-16Tussi Pres B480 mL in 1 BOTTLESYRUP4805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-237TUSSI PRES B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]4Current NDC, Legacy NDC, 3 package rows20191106_d0afa44c-3acf-42a5-9889-4e9c10225256.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148155brompheniramine maleate 4 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSNd0afa44c-3acf-42a5-9889-4e9c102252565
1148155brompheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 4 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCDd0afa44c-3acf-42a5-9889-4e9c102252565
1148155brompheniramine maleate 4 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral SolutionSYd0afa44c-3acf-42a5-9889-4e9c102252565

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52083-237-015208302370130 mL in 1 BOTTLE (52083-237-01) 30 ml2011-03-290000-00-00NoNoCurrent
52083-237-0452083023704120 mL in 1 BOTTLE (52083-237-04) 120 ml2011-03-290000-00-00NoNoCurrent
52083-237-1652083023716480 mL in 1 BOTTLE (52083-237-16) 480 ml2011-03-290000-00-00NoNoCurrent