FDA.reportPublic FDA data

Mucus Relief DM

Product NDC
11822-7340
11-digit product format
118227340
Labeler code
11822
Product ID
11822-7340_180e8c2f-9d06-4c91-8939-abcbde8c11a5
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
TABLET
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA209692
Marketing category
ANDA
Marketing start
2019-05-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief DM
Brand name suffix
Maximum Strength

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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-7340-42020-11-17C16284748780-1ab0e2407-276e-f274-e053-dbdaa90a6471Drug Facts
11822-7340-42020-09-27C16284748780-1ab0e2407-276e-f274-e053-dbdaa90a6471Drug Facts
11822-7340-42020-09-25C16284748780-1ab0e2407-276e-f274-e053-dbdaa90a6471Drug Facts
11822-7340-42020-07-22C16284748780-1ab0e2407-276e-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-7340-4Mucus Relief DMMaximum Strength42 in 1 CARTONTABLET424
11822-7340-4Mucus Relief DMMaximum Strength1 in 1 BLISTER PACKTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-7340MUCUS RELIEF DM MAXIMUM STRENGTH (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [RITE AID CORPORATION]3Current NDC, Legacy NDC, 2 package rows20220127_8467474f-6278-47d9-8228-451d08ddf983.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN8467474f-6278-47d9-8228-451d08ddf9834
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD8467474f-6278-47d9-8228-451d08ddf9834
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY8467474f-6278-47d9-8228-451d08ddf9834

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-7340-41182273400442 BLISTER PACK in 1 CARTON (11822-7340-4) / 1 TABLET in 1 BLISTER PACK42 blister pack2019-05-312026-12-31NoNoCurrent