FDA.reportPublic FDA data

Presgen

Product NDC
52083-632
11-digit product format
520830632
Labeler code
52083
Product ID
52083-632_c3363889-6ee4-4e45-9233-712513223055
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide
Dosage form
SYRUP
Route
ORAL
Labeler
Kramer Novis
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-03-28
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10; 200; 5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN200 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1098647

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52083-632-162025-11-18C16284748780-12cef2736-8d88-d83d-e063-dadaa90ab31fPRESGEN
52083-632-162025-01-30C16284748780-12cef2736-8d88-d83d-e063-dadaa90ab31fPRESGEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-632-16Presgen480 mL in 1 BOTTLESYRUP4805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-632-16ML - Milliliter52083-632a971900b-09fd-4689-add7-97b8dc07d66612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHPRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
GUAIFENESINACTIVE INGREDIENT495W7451VQPRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSPRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
GUAIFENESINACTIVE MOIETY495W7451VQPRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1
WATERINACTIVE INGREDIENT059QF0KO0RPRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-632PRESGEN (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [KRAMER NOVIS]4Current NDC, Legacy NDC, 1 package rows20221029_edad7a86-0d27-4a98-85b2-4b6725904f28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098647dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 10 mL Oral SolutionPSNedad7a86-0d27-4a98-85b2-4b6725904f285
1098647dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCDedad7a86-0d27-4a98-85b2-4b6725904f285
1098647dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSYedad7a86-0d27-4a98-85b2-4b6725904f285
1098647dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 10 ML Oral SolutionSYedad7a86-0d27-4a98-85b2-4b6725904f285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52083-632-1652083063216480 mL in 1 BOTTLE (52083-632-16) 480 ml2011-03-280000-00-00NoNoCurrent