FDA.reportPublic FDA data

Mucus Relief DM

Product NDC
69842-933
11-digit product format
698420933
Labeler code
69842
Product ID
69842-933_cd5bb547-ad4b-4f82-adea-6ed630be1f9b
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
TABLET
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA209692
Marketing category
ANDA
Marketing start
2019-02-28
Marketing end
2026-08-28
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
30; 600 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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/1
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1298324

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
69842-933-202020-10-26C16284748780-1ab0e2407-307f-f274-e053-dbdaa90a6471Drug Facts
69842-933-402020-10-26C16284748780-1ab0e2407-307f-f274-e053-dbdaa90a6471Drug Facts
69842-933-202020-09-27C16284748780-1ab0e2407-307f-f274-e053-dbdaa90a6471Drug Facts
69842-933-402020-09-27C16284748780-1ab0e2407-307f-f274-e053-dbdaa90a6471Drug Facts
69842-933-202020-09-25C16284748780-1ab0e2407-307f-f274-e053-dbdaa90a6471Drug Facts
69842-933-402020-09-25C16284748780-1ab0e2407-307f-f274-e053-dbdaa90a6471Drug Facts
69842-933-202020-07-22C16284748780-1ab0e2407-307f-f274-e053-dbdaa90a6471Drug Facts
69842-933-402020-07-22C16284748780-1ab0e2407-307f-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-933-20Mucus Relief DM20 in 1 CARTONTABLET204
69842-933-20Mucus Relief DM1 in 1 BLISTER PACKTABLET14
69842-933-40Mucus Relief DM40 in 1 CARTONTABLET404
69842-933-40Mucus Relief DM1 in 1 BLISTER PACKTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-933MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [CVS PHARMACY]3Current NDC, Legacy NDC, 4 package rows20221123_59c338a0-8dc9-43a7-b8df-c26ae475def3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN59c338a0-8dc9-43a7-b8df-c26ae475def34
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD59c338a0-8dc9-43a7-b8df-c26ae475def34
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY59c338a0-8dc9-43a7-b8df-c26ae475def34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-933-206984209332020 BLISTER PACK in 1 CARTON (69842-933-20) / 1 TABLET in 1 BLISTER PACK20 blister pack2019-02-282026-08-28NoNoCurrent
69842-933-406984209334040 BLISTER PACK in 1 CARTON (69842-933-40) / 1 TABLET in 1 BLISTER PACK40 blister pack2019-02-282026-08-28NoNoCurrent