FDA.reportPublic FDA data

rugby cough syrup

Product NDC
68788-8303
11-digit product format
687888303
Labeler code
68788
Product ID
68788-8303_1b5fc00d-0bc4-4b38-a8fb-a1b61017a801
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc
Application
341
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-23
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 200 mg/20mL; mg/20mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
rugby cough syrup
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN200 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1790650

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8303-1rugby cough syrup1 in 1 CARTONSOLUTION15
68788-8303-1rugby cough syrup118 mL in 1 BOTTLESOLUTION1185

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8303RUGBY COUGH SYRUP (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [PREFERRED PHARMACEUTICALS INC]3Current NDC, 2 package rows20250312_c0f389ec-a683-4555-8892-896b3165952a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790650dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral SolutionPSNc0f389ec-a683-4555-8892-896b3165952a5
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCDc0f389ec-a683-4555-8892-896b3165952a5
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSYc0f389ec-a683-4555-8892-896b3165952a5
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSYc0f389ec-a683-4555-8892-896b3165952a5
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSYc0f389ec-a683-4555-8892-896b3165952a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8303-1687888303011 BOTTLE in 1 CARTON (68788-8303-1) / 118 mL in 1 BOTTLE1 bottle2023-01-23NoNoHistorical