FDA.reportPublic FDA data

Presgen B

Product NDC
52083-637
11-digit product format
520830637
Labeler code
52083
Product ID
52083-637_0e6e64a1-f9ee-47cb-8ee7-23800b7fb564
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
Presgen 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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52083-637-162025-12-10C16284748780-12cef2736-65f4-d83d-e063-dadaa90ab31fPRESGEN ® B
52083-637-162025-01-30C16284748780-12cef2736-65f4-d83d-e063-dadaa90ab31fPRESGEN ® B

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-637-16Presgen B480 mL in 1 BOTTLESYRUP4805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-637PRESGEN B (DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]4Current NDC, Legacy NDC, 1 package rows20191102_5befa829-32bd-4978-8a0e-1d6513ff37a4.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 SolutionPSN5befa829-32bd-4978-8a0e-1d6513ff37a45
1148155brompheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 4 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCD5befa829-32bd-4978-8a0e-1d6513ff37a45
1148155brompheniramine maleate 4 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral SolutionSY5befa829-32bd-4978-8a0e-1d6513ff37a45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52083-637-1652083063716480 mL in 1 BOTTLE (52083-637-16) 480 ml2011-03-290000-00-00NoNoCurrent