FDA.reportPublic FDA data

berkley and jensen tussin dm

Product NDC
68391-299
11-digit product format
683910299
Labeler code
68391
Product ID
68391-299_0ca69d3c-9854-47d1-9613-1bae9416051d
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
BJWC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-02
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
berkley and jensen tussin dm
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
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
68391-299-34berkley and jensen tussin dm1 in 1 CARTONSOLUTION12
68391-299-34berkley and jensen tussin dm237 mL in 1 BOTTLESOLUTION2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-299BERKLEY AND JENSEN TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [BJWC]2Current NDC, Legacy NDC, 2 package rows20241120_b2de91c9-6af0-4881-8d2d-a69d90c8dfcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNb2de91c9-6af0-4881-8d2d-a69d90c8dfcd2
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDb2de91c9-6af0-4881-8d2d-a69d90c8dfcd2
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYb2de91c9-6af0-4881-8d2d-a69d90c8dfcd2
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYb2de91c9-6af0-4881-8d2d-a69d90c8dfcd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-299-34683910299341 BOTTLE in 1 CARTON (68391-299-34) / 237 mL in 1 BOTTLE1 bottle2022-01-020000-00-00NoNoCurrent