FDA.reportPublic FDA data

Mucus Relief DM Extended Release Caplets

Product NDC
0536-1161
11-digit product format
005361161
Labeler code
0536
Product ID
0536-1161_f6b72325-a048-4e79-ac83-aa61ae564f81
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rugby Laboratories
Application
ANDA209692
Marketing category
ANDA
Marketing start
2018-12-13
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 Extended Release Caplets
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1161-34Mucus Relief DM Extended Release Caplets20 in 1 CARTONTABLET, EXTENDED RELEASE209
0536-1161-34Mucus Relief DM Extended Release Caplets1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE19
0536-1161-37Mucus Relief DM Extended Release Caplets1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE19
0536-1161-37Mucus Relief DM Extended Release Caplets40 in 1 CARTONTABLET, EXTENDED RELEASE409

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1161-34EA - Each0536-11616d90fe03-3d29-4688-8aaf-81999e7a3ab512019-01-24
0536-1161-37EA - Each0536-1161099062de-6c77-43ba-a98a-b3253ae04f5912019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1161MUCUS RELIEF DM EXTENDED RELEASE CAPLETS (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [RUGBY LABORATORIES, INC.]8Current NDC, Legacy NDC, 4 package rows20250501_69cd399a-0103-4543-bb06-c7cccffe9cc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN69cd399a-0103-4543-bb06-c7cccffe9cc49
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD69cd399a-0103-4543-bb06-c7cccffe9cc49
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY69cd399a-0103-4543-bb06-c7cccffe9cc49
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN308f50dd-e8d6-0264-e063-6394a90afa685
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD308f50dd-e8d6-0264-e063-6394a90afa685
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY308f50dd-e8d6-0264-e063-6394a90afa685

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1161-340053611613420 BLISTER PACK in 1 CARTON (0536-1161-34) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK20 blister pack2018-12-132027-02-28NoNoCurrent
0536-1161-370053611613740 BLISTER PACK in 1 CARTON (0536-1161-37) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK40 blister pack2018-12-130000-00-00NoNoCurrent