FDA.reportPublic FDA data

Mucinex Cough Chest Congestion

Product NDC
72854-137
11-digit product format
728540137
Labeler code
72854
Product ID
72854-137_51b8027e-7ca8-4dd4-e063-6294a90af406
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10; 200 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucinex Cough Chest Congestion
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
GUAIFENESIN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1111663

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-137-16Mucinex Cough Chest Congestion2 in 1 CARTONCAPSULE, LIQUID FILLED25
72854-137-16Mucinex Cough Chest Congestion8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED85

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72854-137-16EA - Each72854-1372c1009be-3158-4185-a745-1b82f4d90f8b12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72854-137MUCINEX COUGH CHEST CONGESTION (DEXTROMETHORPHAN HBR, GUAIFENESIN) CAPSULE, LIQUID FILLED [RB HEALTH (US) LLC]4Current NDC, Legacy NDC, 2 package rows20241225_e9c32d81-cd9b-4ff2-e053-2995a90aa499.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111663dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral CapsulePSNe9c32d81-cd9b-4ff2-e053-2995a90aa4995
1111663dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral CapsuleSCDe9c32d81-cd9b-4ff2-e053-2995a90aa4995

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72854-137-16728540137162 BLISTER PACK in 1 CARTON (72854-137-16) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2022-07-010000-00-00NoNoCurrent