FDA.reportPublic FDA data

Mucus Relief DM Extended Release Caplets

Product NDC
70000-0464
11-digit product format
700000464
Labeler code
70000
Product ID
70000-0464_55dad94f-71e8-4e1e-bd70-520033e6d8cd
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health (Leader) 70000
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
70000-0464-1Mucus Relief DM Extended Release Caplets1 in 1 BLISTER PACKTABLET16
70000-0464-1Mucus Relief DM Extended Release Caplets28 in 1 CARTONTABLET286
70000-0464-2Mucus Relief DM Extended Release Caplets1 in 1 BLISTER PACKTABLET16
70000-0464-2Mucus Relief DM Extended Release Caplets14 in 1 CARTONTABLET146

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0464-1EA - Each70000-0464b7adbd4c-739f-4573-a597-3622f00b224912019-06-19
70000-0464-2EA - Each70000-04642a77bba2-576c-4b4b-bdf7-27baa7caeae712019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0464MUCUS RELIEF DM EXTENDED RELEASE CAPLETS (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [CARDINAL HEALTH (LEADER) 70000]6Current NDC, Legacy NDC, 4 package rows20221021_04af43e6-6276-42ec-a902-3de22bc9fdea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN04af43e6-6276-42ec-a902-3de22bc9fdea6
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD04af43e6-6276-42ec-a902-3de22bc9fdea6
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY04af43e6-6276-42ec-a902-3de22bc9fdea6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0464-17000004640128 BLISTER PACK in 1 CARTON (70000-0464-1) / 1 TABLET in 1 BLISTER PACK28 blister pack2018-12-310000-00-00NoNoCurrent
70000-0464-27000004640214 BLISTER PACK in 1 CARTON (70000-0464-2) / 1 TABLET in 1 BLISTER PACK14 blister pack2018-12-310000-00-00NoNoCurrent