FDA.reportPublic FDA data

Mucus Relief DM

Product NDC
59726-733
11-digit product format
597260733
Labeler code
59726
Product ID
59726-733_25a81a18-9757-4dcf-89d7-6413afb909e4
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
TABLET
Route
ORAL
Labeler
P & L Development, LLC
Application
ANDA209692
Marketing category
ANDA
Marketing start
2018-12-31
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
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief DM
Listing expiration
2027-12-31

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59726-733-402020-12-05C16284748780-1ab0e2407-28bd-f274-e053-dbdaa90a6471Drug Facts
59726-733-402020-09-27C16284748780-1ab0e2407-28bd-f274-e053-dbdaa90a6471Drug Facts
59726-733-402020-09-25C16284748780-1ab0e2407-28bd-f274-e053-dbdaa90a6471Drug Facts
59726-733-402020-07-22C16284748780-1ab0e2407-28bd-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59726-733-06Mucus Relief DM1 in 1 BLISTER PACKTABLET15
59726-733-06Mucus Relief DM6 in 1 CARTONTABLET65
59726-733-20Mucus Relief DM1 in 1 BLISTER PACKTABLET15
59726-733-20Mucus Relief DM20 in 1 CARTONTABLET205
59726-733-40Mucus Relief DM1 in 1 BLISTER PACKTABLET15
59726-733-40Mucus Relief DM40 in 1 CARTONTABLET405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-733MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [P & L DEVELOPMENT, LLC]4Current NDC, Legacy NDC, 6 package rows20220217_a397799d-46a6-447b-9498-17436d218e29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNa397799d-46a6-447b-9498-17436d218e295
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDa397799d-46a6-447b-9498-17436d218e295
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYa397799d-46a6-447b-9498-17436d218e295

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59726-733-06597260733066 BLISTER PACK in 1 CARTON (59726-733-06) / 1 TABLET in 1 BLISTER PACK6 blister pack2018-12-310000-00-00NoNoCurrent
59726-733-205972607332020 BLISTER PACK in 1 CARTON (59726-733-20) / 1 TABLET in 1 BLISTER PACK20 blister pack2018-12-31NoNoCurrent
59726-733-405972607334040 BLISTER PACK in 1 CARTON (59726-733-40) / 1 TABLET in 1 BLISTER PACK40 blister pack2018-12-310000-00-00NoNoCurrent