DELTUSS DMX Cough Suppressant Nasal Decongestant Antihistamine GRAPE Flavor

Product NDC
58238-225
11-digit product format
582380225
Labeler code
58238
Product ID
58238-225_cfd4bceb-ba9b-c5f7-e053-2a95a90a2faa
Type
HUMAN OTC DRUG
Nonproprietary name
DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
Deliz Pharmaceutical Corp
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-03-20
Marketing end
0000-00-00
Substance
DEXCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
1 mg/5mL; mg/5mL; mg/5mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58238-225IInactivated by FDA2026-10-05
excluded packagepackage58238-22558238-225-04IInactivated 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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58238-225-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58238-225-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58238-225-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58238-225-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58238-225-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58238-225-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58238-225-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58238-225-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58238-225-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58238-225-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58238-225-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58238-225-04557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage58238-225-048af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage58238-225-04834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage58238-225-041332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage58238-225-04fb8cb913e6d1…eb8c232b6be0…

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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
44893bf2-1be4-4e68-8bc4-bbb0f543085eProduct name120180830
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58238-225-042022-07-29C16284748780-1e4f33bdf-a847-d8a0-e053-dadaa90a6e4eDELTUSS DMX Cough Suppressant Nasal Decongestant Antihistamine GRAPE Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58238-225-04DELTUSS DMX Cough Suppressant Nasal Decongestant Antihistamine GRAPE Flavor118 mL in 1 BOTTLELIQUID1186
58238-225-04DELTUSS DMX Cough Suppressant Nasal Decongestant Antihistamine GRAPE Flavor1 in 1 CARTONLIQUID16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXCHLORPHENIRAMINE MALEATEACTIVE INGREDIENTB10YD955QWDELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]4
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]4
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NDELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]4
DEXCHLORPHENIRAMINEACTIVE MOIETY3Q9Q0B929NDELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]4
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FDELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]4
SORBITOLINACTIVE INGREDIENT506T60A25RDELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]4
WATERINACTIVE INGREDIENT059QF0KO0RDELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58238-225DELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]6Legacy NDC, 2 package rows20211103_783eaa30-c889-48e9-8ac6-22d3fecc84c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298433dexchlorpheniramine maleate 1 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN783eaa30-c889-48e9-8ac6-22d3fecc84c86
1298433dexchlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 3 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD783eaa30-c889-48e9-8ac6-22d3fecc84c86
1298433dexchlorpheniramine maleate 1 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG per 5 ML Oral SolutionSY783eaa30-c889-48e9-8ac6-22d3fecc84c86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58238-225-04582380225041 BOTTLE in 1 CARTON (58238-225-04) > 118 mL in 1 BOTTLE1 bottle2015-03-200000-00-00NoNoCurrent