Ritussin DM

Product NDC
53807-409
11-digit product format
538070409
Labeler code
53807
Product ID
53807-409_164bd740-f8ea-4d66-ac89-5ef9e2165ec1
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Dosage form
LIQUID
Route
ORAL
Labeler
Rij Pharmaceutical Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1999-03-16
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10 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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53807-409-042020-01-31C16284748780-19d75b9d1-010b-f424-e053-dadaa90a57ceDrug Facts
53807-409-082020-01-31C16284748780-19d75b9d1-010b-f424-e053-dadaa90a57ceDrug Facts
53807-409-162020-01-31C16284748780-19d75b9d1-010b-f424-e053-dadaa90a57ceDrug Facts
53807-409-282020-01-31C16284748780-19d75b9d1-010b-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53807-409-04Ritussin DM118 mL in 1 BOTTLELIQUID1182
53807-409-08Ritussin DM236 mL in 1 BOTTLELIQUID2362
53807-409-16Ritussin DM473 mL in 1 BOTTLELIQUID4732
53807-409-28Ritussin DM3785 mL in 1 BOTTLELIQUID37852

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHRITUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
GUAIFENESINACTIVE INGREDIENT495W7451VQRITUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSRITUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
GUAIFENESINACTIVE MOIETY495W7451VQRITUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLRITUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2RITUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARITUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXRITUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SRITUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ARITUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYRITUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EURITUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RRITUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53807-409RITUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]2Legacy NDC, 4 package rows20180502_c4dea261-c233-49a4-a805-db01d89ae051.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSNc4dea261-c233-49a4-a805-db01d89ae0512
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDc4dea261-c233-49a4-a805-db01d89ae0512
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYc4dea261-c233-49a4-a805-db01d89ae0512
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYc4dea261-c233-49a4-a805-db01d89ae0512
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYc4dea261-c233-49a4-a805-db01d89ae0512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53807-409-0453807040904118 mL in 1 BOTTLE118 mlHistorical
53807-409-0853807040908236 mL in 1 BOTTLE236 mlHistorical
53807-409-1653807040916473 mL in 1 BOTTLE473 mlHistorical
53807-409-28538070409283785 mL in 1 BOTTLE3785 mlHistorical