FDA.reportPublic FDA data

Berkley and Jensen Mucus Relief DM

Product NDC
68391-812
11-digit product format
683910812
Labeler code
68391
Product ID
68391-812_c9e7328c-7360-4aba-b6bb-9b229ecbaee4
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan HBr, guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
BJWC
Application
ANDA207602
Marketing category
ANDA
Marketing start
2020-07-15
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
60; 1200 mg/1; mg/1
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 Mucus Relief DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE60 mg/1
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1099074

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
68391-812-01Berkley and Jensen Mucus Relief DM84 in 1 BOTTLETABLET, EXTENDED RELEASE842
68391-812-01Berkley and Jensen Mucus Relief DM1 in 1 CARTONTABLET, EXTENDED RELEASE12
68391-812-45Berkley and Jensen Mucus Relief DM1 in 1 CARTONTABLET, EXTENDED RELEASE12
68391-812-45Berkley and Jensen Mucus Relief DM56 in 1 BOTTLETABLET, EXTENDED RELEASE562

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-812BERKLEY AND JENSEN MUCUS RELIEF DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, EXTENDED RELEASE [BJWC]1Current NDC, Legacy NDC, 4 package rows20201008_d3b94cce-e6f3-43ec-a927-7b7183744433.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNd3b94cce-e6f3-43ec-a927-7b71837444332
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDd3b94cce-e6f3-43ec-a927-7b71837444332
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYd3b94cce-e6f3-43ec-a927-7b71837444332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-812-01683910812011 BOTTLE in 1 CARTON (68391-812-01) / 84 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2025-09-04NoNoCurrent
68391-812-45683910812451 BOTTLE in 1 CARTON (68391-812-45) / 56 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-07-150000-00-00NoNoCurrent