FDA.reportPublic FDA data

TRISPEC DMX Cough Suppressant Expectorant Peach Flavor

Product NDC
58238-227
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58238-227IInactivated by FDA2026-08-03
excluded packagepackage58238-22758238-227-04IInactivated by FDA2026-08-03

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