FDA.reportPublic FDA data

GENCONTUSS

Product NDC
52083-650
11-digit product format
520830650
Labeler code
52083
Product ID
52083-650_8a52f9ca-43f9-4f88-ae67-2ee6e1541d51
Type
HUMAN OTC DRUG
Nonproprietary name
CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
KRAMER NOVIS
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-08
Substance
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2; 10; 5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
GENCONTUSS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE2 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV1Q0O9OJ9Z, 9D2RTI9KYH, 04JA59TNSJ
Rxcui1363752

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
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
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
52083-650-162025-11-14C16284748780-12cef2736-5da3-d83d-e063-dadaa90ab31fGENCONTUSS
52083-650-162025-11-14C16284748780-12cef2736-5da3-d83d-e063-dadaa90ab31fGENCONTUSS ®
52083-650-162025-01-30C16284748780-12cef2736-5da3-d83d-e063-dadaa90ab31fGENCONTUSS
52083-650-162025-01-30C16284748780-12cef2736-5da3-d83d-e063-dadaa90ab31fGENCONTUSS ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-650-16GENCONTUSS473 mL in 1 BOTTLE, PLASTICSOLUTION4737

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-650-16ML - Milliliter52083-65006ae7d11-09ed-4531-ad88-041ec9f515c212015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZGENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHGENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJGENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UGENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSGENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVGENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPGENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRGENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4GENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS]1
SUCROSEINACTIVE INGREDIENTC151H8M554GENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS]1
WATERINACTIVE INGREDIENT059QF0KO0RGENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-650GENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KRAMER NOVIS]5Current NDC, Legacy NDC, 1 package rows20221029_69d16d25-b09b-430e-8e01-0962d840dc21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSN69d16d25-b09b-430e-8e01-0962d840dc217
1363752chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD69d16d25-b09b-430e-8e01-0962d840dc217
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY69d16d25-b09b-430e-8e01-0962d840dc217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52083-650-1652083065016473 mL in 1 BOTTLE, PLASTIC (52083-650-16) 473 ml2015-06-080000-00-00NoNoCurrent