FDA.reportPublic FDA data

mucus dm extended release

Product NDC
69842-812
11-digit product format
698420812
Labeler code
69842
Product ID
69842-812_8293e6c8-35ed-481d-ad0d-396eb942be64
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin, dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA207602
Marketing category
ANDA
Marketing start
2018-05-03
Marketing end
2026-12-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
mucus dm extended release

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
69842-812-30mucus dm extended release28 in 1 BOTTLETABLET, EXTENDED RELEASE282
69842-812-30mucus dm extended release1 in 1 CARTONTABLET, EXTENDED RELEASE12
69842-812-55mucus dm extended release1 in 1 CARTONTABLET, EXTENDED RELEASE12
69842-812-55mucus dm extended release42 in 1 BOTTLETABLET, EXTENDED RELEASE422
69842-812-66mucus dm extended release1 in 1 CARTONTABLET, EXTENDED RELEASE12
69842-812-66mucus dm extended release14 in 1 BOTTLETABLET, EXTENDED RELEASE142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-812-55EA - Each69842-8122bae38fc-de62-493b-a5ab-52827c9095a012024-03-12
69842-812-66EA - Each69842-812ccca812b-a257-4479-954e-cc8fb1287db612020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-812MUCUS DM EXTENDED RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [CVS PHARMACY]1Current NDC, Legacy NDC, 6 package rows20180504_1bc37ee4-df27-4358-b724-6b55406dbce6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN1bc37ee4-df27-4358-b724-6b55406dbce62
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD1bc37ee4-df27-4358-b724-6b55406dbce62
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY1bc37ee4-df27-4358-b724-6b55406dbce62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-812-30698420812301 BOTTLE in 1 CARTON (69842-812-30) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-05-032026-05-31NoNoCurrent
69842-812-55698420812551 BOTTLE in 1 CARTON (69842-812-55) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-05-032026-12-31NoNoCurrent
69842-812-66698420812661 BOTTLE in 1 CARTON (69842-812-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-05-032026-12-31NoNoCurrent