FDA.reportPublic FDA data

MUCUS RELIEF DM

Product NDC
51316-671
11-digit product format
513160671
Labeler code
51316
Product ID
51316-671_cb1daa23-e906-4a3f-b3d5-82fe1bef6b35
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
ANDA207602
Marketing category
ANDA
Marketing start
2025-12-17
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-671-55MUCUS RELIEF DM42 in 1 BOTTLETABLET, EXTENDED RELEASE423
51316-671-55MUCUS RELIEF DM1 in 1 CARTONTABLET, EXTENDED RELEASE13
51316-671-66MUCUS RELIEF DM1 in 1 CARTONTABLET, EXTENDED RELEASE13
51316-671-66MUCUS RELIEF DM14 in 1 BOTTLETABLET, EXTENDED RELEASE143

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN85ecf5bf-28a1-4b9d-9e99-c9e91ddc85e13
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD85ecf5bf-28a1-4b9d-9e99-c9e91ddc85e13
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY85ecf5bf-28a1-4b9d-9e99-c9e91ddc85e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-671-55513160671551 BOTTLE in 1 CARTON (51316-671-55) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2025-12-17NoNoCurrent
51316-671-66513160671661 BOTTLE in 1 CARTON (51316-671-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2026-01-12NoNoCurrent