FDA.reportPublic FDA data

TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor

Product NDC
58238-230
11-digit product format
582380230
Labeler code
58238
Product ID
58238-230_1e66114f-db78-443f-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
Deliz Pharmaceutical Corp
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-02-27
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
10 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product 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
58238-230-022020-01-31C16284748780-19d75b9cf-d37f-f424-e053-dadaa90a57ceTRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58238-230-02TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor1 in 1 CARTONLIQUID12
58238-230-02TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor60 mL in 1 BOTTLELIQUID602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58238-230-02ML - Milliliter58238-2309ab5b2b7-1972-44d0-a5a6-083b7652006e12015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]1
GUAIFENESINACTIVE INGREDIENT495W7451VQTRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NTRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]1
GUAIFENESINACTIVE MOIETY495W7451VQTRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FTRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]1
AMMONIUM GLYCYRRHIZATEINACTIVE INGREDIENT3VRD35U26CTRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]1
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFTRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4TRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]1
SORBITOLINACTIVE INGREDIENT506T60A25RTRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4TRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RTRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58238-230TRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]2Legacy NDC, 2 package rows20170406_b4630613-c78c-4f97-bd6c-0476899f5b90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435143dextromethorphan HBr 10 MG / guaiFENesin 187 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSNb4630613-c78c-4f97-bd6c-0476899f5b902
1435143dextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCDb4630613-c78c-4f97-bd6c-0476899f5b902
1435143dextromethorphan HBr 10 MG / guaifenesin 187 MG / pseudoephedrine HCl 30 MG per 5 ML Oral SolutionSYb4630613-c78c-4f97-bd6c-0476899f5b902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
58238-230-02582380230021 in 1 CARTONHistorical