FDA.reportPublic FDA data

Mucus Relief DM Extended Release Caplets

Product NDC
63868-870
11-digit product format
638680870
Labeler code
63868
Product ID
63868-870_63708ea4-8e73-41a7-9bb7-184d112f86be
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
TABLET
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
ANDA209692
Marketing category
ANDA
Marketing start
2018-12-31
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief DM Extended Release Caplets
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE60 mg/1
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1099074

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-870-142023-05-03C16284748780-1ab0e2407-2aee-f274-e053-dbdaa90a6471Drug Facts
63868-870-142023-01-30C16284748780-1ab0e2407-2aee-f274-e053-dbdaa90a6471Drug Facts
63868-870-142020-11-30C16284748780-1ab0e2407-2aee-f274-e053-dbdaa90a6471Drug Facts
63868-870-142020-09-27C16284748780-1ab0e2407-2aee-f274-e053-dbdaa90a6471Drug Facts
63868-870-142020-09-25C16284748780-1ab0e2407-2aee-f274-e053-dbdaa90a6471Drug Facts
63868-870-142020-07-22C16284748780-1ab0e2407-2aee-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-870-14Mucus Relief DM Extended Release Caplets1 in 1 BLISTER PACKTABLET13
63868-870-14Mucus Relief DM Extended Release Caplets14 in 1 CARTONTABLET143

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-870-14EA - Each63868-870294772a8-d8c4-447d-8f3d-4b6b968c074212022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-870MUCUS RELIEF DM EXTENDED RELEASE CAPLETS (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3Current NDC, Legacy NDC, 2 package rows20230504_ee34af0f-61ba-49fa-81e0-20da4c582368.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNee34af0f-61ba-49fa-81e0-20da4c5823683
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDee34af0f-61ba-49fa-81e0-20da4c5823683
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYee34af0f-61ba-49fa-81e0-20da4c5823683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-870-146386808701414 BLISTER PACK in 1 CARTON (63868-870-14) / 1 TABLET in 1 BLISTER PACK14 blister pack2018-12-310000-00-00NoNoCurrent