FDA.reportPublic FDA data

DOMETUSS-DA

Product NDC
53809-206
Requested package NDC
53809-206-04
11-digit product format
538090206
Labeler code
53809
Product ID
53809-206_0a1b6678-feef-4381-ad56-c5023e5c7f79
Type
HUMAN OTC DRUG
Nonproprietary name
CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
LIQUID
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; PHENYLEPHRINE HYDROCHLORIDE
Active strength
1 mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53809-20653809-206-04IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 7 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
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
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53809-206-042025-05-20C16284748780-12cef2736-5f47-d83d-e063-dadaa90ab31fDOMETUSS-DA
53809-206-042025-01-30C16284748780-12cef2736-5f47-d83d-e063-dadaa90ab31fDOMETUSS-DA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53809-206-04DOMETUSS-DA118 mL in 1 BOTTLELIQUID1184

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53809-206-04ML - Milliliter53809-206c35cdd8d-06df-46f9-9292-6619ce5dfe2912016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53809-206DOMETUSS-DA (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DOMEL LABORATORIES]4Legacy NDC, 1 package rows20250522_b5def3fb-90b9-4b7e-bb22-745804b0566a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1429345chlorpheniramine maleate 1 MG / phenylephrine hydrochloride 2.5 MG in 5 mL Oral SolutionPSNb5def3fb-90b9-4b7e-bb22-745804b0566a4
1429345chlorpheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDb5def3fb-90b9-4b7e-bb22-745804b0566a4
1429345chlorpheniramine maleate 1 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSYb5def3fb-90b9-4b7e-bb22-745804b0566a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53809-206-0453809020604118 mL in 1 BOTTLE (53809-206-04) 118 ml2016-01-210000-00-00NoNoCurrent