FDA.reportPublic FDA data

Mucinex Fast-Max Chest Congestion Honey and Berry Flavor

Product NDC
63824-537
11-digit product format
638240537
Labeler code
63824
Product ID
63824-537_51b44481-a7b9-8a46-e063-6294a90aefda
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-01
Substance
GUAIFENESIN
Active strength
400 mg/20mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucinex Fast-Max Chest Congestion Honey and Berry Flavor
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN400 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310604, 669126

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
63824-537-66Mucinex Fast-Max Chest Congestion Honey and Berry Flavor180 mL in 1 BOTTLESOLUTION1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-537MUCINEX FAST-MAX CHEST CONGESTION HONEY AND BERRY FLAVOR (GUAIFENESIN) SOLUTION [RB HEALTH (US) LLC]4Current NDC, Legacy NDC, 1 package rows20241228_8ec74cf2-88f5-40be-87e2-b756ab841754.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN8ec74cf2-88f5-40be-87e2-b756ab8417545
669126Mucinex 100 MG in 5 mL Oral SolutionPSN8ec74cf2-88f5-40be-87e2-b756ab8417545
669126guaifenesin 20 MG/ML Oral Solution [Mucinex]SBD8ec74cf2-88f5-40be-87e2-b756ab8417545
310604guaifenesin 20 MG/ML Oral SolutionSCD8ec74cf2-88f5-40be-87e2-b756ab8417545
669126Children's Mucinex 20 MG/ML Oral SolutionSY8ec74cf2-88f5-40be-87e2-b756ab8417545
310604guaifenesin 100 MG per 5 ML Oral SolutionSY8ec74cf2-88f5-40be-87e2-b756ab8417545
310604guaifenesin 100 MG per 5 ML Oral SyrupSY8ec74cf2-88f5-40be-87e2-b756ab8417545
310604guaifenesin 200 MG per 10 ML Oral SolutionSY8ec74cf2-88f5-40be-87e2-b756ab8417545
310604guaifenesin 300 MG per 15 ML Oral SolutionSY8ec74cf2-88f5-40be-87e2-b756ab8417545
310604guaifenesin 400 MG per 20 ML Oral SolutionSY8ec74cf2-88f5-40be-87e2-b756ab8417545
669126Mucinex 100 MG per 5 ML Oral SolutionSY8ec74cf2-88f5-40be-87e2-b756ab8417545
669126Mucinex 20 MG/ML Oral SolutionSY8ec74cf2-88f5-40be-87e2-b756ab8417545

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-537-6663824053766180 mL in 1 BOTTLE (63824-537-66) 180 ml2020-06-010000-00-00NoNoCurrent