FDA.reportPublic FDA data

DOMETUSS-NR

Product NDC
53809-240
11-digit product format
538090240
Labeler code
53809
Product ID
53809-240_a0119974-f4dc-4a21-8934-6a4b74f578e3
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Domel Laboratories
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-01-21
Marketing end
0000-00-00
Substance
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
4 mg/1; mg/1; mg/1
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53809-240IInactivated by FDA2026-10-12
excluded packagepackage53809-24053809-240-01IInactivated by FDA2026-10-12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53809-240-01DOMETUSS-NR100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53809-240DOMETUSS-NR (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [DOMEL LABORATORIES]2Legacy NDC, 1 package rows20241208_ef8abf4f-ce65-45c9-9df2-23e673c13756.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2167752chlorpheniramine maleate 4 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Oral TabletPSNef8abf4f-ce65-45c9-9df2-23e673c137562
2167752chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Oral TabletSCDef8abf4f-ce65-45c9-9df2-23e673c137562
2167752chlorpheniramine maleate 4 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Oral TabletSYef8abf4f-ce65-45c9-9df2-23e673c137562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53809-240-0153809024001100 TABLET in 1 BOTTLE (53809-240-01) 100 tablet2016-01-210000-00-00NoNoCurrent