TRISPEC DMX Cough Suppressant Expectorant Peach Flavor

Product NDC
58238-227
Requested package NDC
58238-227-04
11-digit product format
582380227
Labeler code
58238
Product ID
58238-227_cfd4b511-8583-0b74-e053-2995a90af6c9
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Dosage form
LIQUID
Route
ORAL
Labeler
Deliz Pharmaceutical Corp
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-11-18
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58238-22758238-227-04IInactivated 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 · 16 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58238-227-042022-07-29C16284748780-1e4f33bdf-b2da-d8a0-e053-dadaa90a6e4eTRISPEC DMX Cough Suppressant Expectorant Peach Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58238-227-04TRISPEC DMX Cough Suppressant Expectorant Peach Flavor1 in 1 PACKAGELIQUID16
58238-227-04TRISPEC DMX Cough Suppressant Expectorant Peach Flavor118 mL in 1 BOTTLELIQUID1186

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58238-227-04ML - Milliliter58238-22719d666df-d817-44c3-bc2d-d1050f31ee9412014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTRISPEC DMX COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]3
GUAIFENESINACTIVE INGREDIENT495W7451VQTRISPEC DMX COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTRISPEC DMX COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]3
GUAIFENESINACTIVE MOIETY495W7451VQTRISPEC DMX COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]3
AMMONIUM GLYCYRRHIZATEINACTIVE INGREDIENT3VRD35U26CTRISPEC DMX COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTRISPEC DMX COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTRISPEC DMX COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTRISPEC DMX COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]3
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFTRISPEC DMX COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]3
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4TRISPEC DMX COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRISPEC DMX COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTRISPEC DMX COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]3
SORBITOLINACTIVE INGREDIENT506T60A25RTRISPEC DMX COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4TRISPEC DMX COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]3
WATERINACTIVE INGREDIENT059QF0KO0RTRISPEC DMX COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58238-227TRISPEC DMX COUGH SUPPRESSANT EXPECTORANT PEACH FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DELIZ PHARMACEUTICAL CORP]6Legacy NDC, 2 package rows20211103_eee53314-655c-496b-bc01-1caa70cbf2b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1441364dextromethorphan HBr 10 MG / guaiFENesin 187 MG in 5 mL Oral SolutionPSNeee53314-655c-496b-bc01-1caa70cbf2b76
1441364dextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML Oral SolutionSCDeee53314-655c-496b-bc01-1caa70cbf2b76
1441364dextromethorphan hydrobromide 10 MG / guaifenesin 187 MG per 5 ML Oral SolutionSYeee53314-655c-496b-bc01-1caa70cbf2b76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58238-227-04582380227041 BOTTLE in 1 PACKAGE (58238-227-04) > 118 mL in 1 BOTTLE1 bottle2014-11-180000-00-00NoNoCurrent