FDA.reportPublic FDA data

DOMETUSS-G

Product NDC
53809-250
Requested package NDC
53809-250-04
11-digit product format
538090250
Labeler code
53809
Product ID
53809-250_dc4a9eb6-1eb6-46ed-b51d-ef80ec05e694
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DOMEL
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-11-11
Marketing end
0000-00-00
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
200 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage53809-25053809-250-04IInactivated 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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53809-250-01DOMETUSS-G100 in 1 BOTTLETABLET1002
53809-250-04DOMETUSS-G4 in 1 BOTTLETABLET42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53809-250DOMETUSS-G (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [DOMEL]2Legacy NDC, 2 package rows20241208_19e06e4d-9efb-4059-a33d-4a89c3a2534c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2572023dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG Oral TabletPSN19e06e4d-9efb-4059-a33d-4a89c3a2534c2
2572023dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD19e06e4d-9efb-4059-a33d-4a89c3a2534c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53809-250-04538090250044 TABLET in 1 BOTTLE (53809-250-04) 4 tablet2019-11-110000-00-00NoNoCurrent