FDA.reportPublic FDA data

DOMETUSS-DA

Product NDC
53809-206
11-digit product format
538090206
Labeler code
53809
Product ID
53809-206_7ed906cf-a0da-450e-a245-2bb689dc997b
Type
HUMAN OTC DRUG
Nonproprietary name
CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
Domel Laboratories
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-01-21
Substance
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
1; 2.5 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOMETUSS-DA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE1 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV1Q0O9OJ9Z, 04JA59TNSJ
Rxcui1429345

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]4Current NDC, Legacy 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