FDA.reportPublic FDA data

mucus relief DM MAX

Product NDC
11822-1812
11-digit product format
118221812
Labeler code
11822
Product ID
11822-1812_f61c91ea-be88-4994-9c34-4a794093dfa2
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan HBr, guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA207602
Marketing category
ANDA
Marketing start
2023-03-13
Marketing end
2026-12-31
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
mucus relief DM MAX

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
11822-1812-0mucus relief DM MAX1 in 1 CARTONTABLET, EXTENDED RELEASE12
11822-1812-0mucus relief DM MAX14 in 1 BOTTLETABLET, EXTENDED RELEASE142
11822-1812-1mucus relief DM MAX2 in 1 CARTONTABLET, EXTENDED RELEASE22
11822-1812-1mucus relief DM MAX14 in 1 BOTTLETABLET, EXTENDED RELEASE142
11822-1812-2mucus relief DM MAX14 in 1 BOTTLETABLET, EXTENDED RELEASE142
11822-1812-2mucus relief DM MAX3 in 1 CARTONTABLET, EXTENDED RELEASE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1812MUCUS RELIEF DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, EXTENDED RELEASE [RITE AID CORPORATION]2Current NDC, 6 package rows20230413_a5fd7378-fd7b-400b-a374-0f3bee37702d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNa5fd7378-fd7b-400b-a374-0f3bee37702d2
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDa5fd7378-fd7b-400b-a374-0f3bee37702d2
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYa5fd7378-fd7b-400b-a374-0f3bee37702d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11822-1812-0118221812001 BOTTLE in 1 CARTON (11822-1812-0) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2023-03-13NoNoHistorical
11822-1812-1118221812012 BOTTLE in 1 CARTON (11822-1812-1) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE2 bottle2023-03-16NoNoHistorical
11822-1812-2118221812023 BOTTLE in 1 CARTON (11822-1812-2) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE3 bottle2023-03-16NoNoHistorical