FDA.reportPublic FDA data

7 Select

Product NDC
10202-740
11-digit product format
102020740
Labeler code
10202
Product ID
10202-740_3a3f8195-4504-492a-e063-6394a90a9bbf
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
7-ELEVEN
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-25
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
7 Select
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1020138

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10202-740-047 SelectMaximum Strength1 in 1 CARTONSOLUTION18
10202-740-047 SelectMaximum Strength118 mL in 1 BOTTLESOLUTION1188

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10202-7407 SELECT MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [7-ELEVEN]7Current NDC, Legacy NDC, 2 package rows20240730_f9475972-0cbb-45c5-9e49-09569f1665a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNf9475972-0cbb-45c5-9e49-09569f1665a78
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDf9475972-0cbb-45c5-9e49-09569f1665a78
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYf9475972-0cbb-45c5-9e49-09569f1665a78
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYf9475972-0cbb-45c5-9e49-09569f1665a78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10202-740-04102020740041 BOTTLE in 1 CARTON (10202-740-04) / 118 mL in 1 BOTTLE1 bottle2019-03-250000-00-00NoNoCurrent