FDA.reportPublic FDA data

Topcare Mucus DM

Product NDC
36800-219
11-digit product format
368000219
Labeler code
36800
Product ID
36800-219_823e6e9f-94e0-451c-8f24-3182a07623c7
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA207602
Marketing category
ANDA
Marketing start
2019-07-10
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare Mucus DM
Listing expiration
2026-12-31

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-219-01Topcare Mucus DM1 in 1 CARTONTABLET, EXTENDED RELEASE15
36800-219-01Topcare Mucus DM20 in 1 BOTTLETABLET, EXTENDED RELEASE205
36800-219-49Topcare Mucus DM1 in 1 CARTONTABLET, EXTENDED RELEASE15
36800-219-49Topcare Mucus DM40 in 1 BOTTLETABLET, EXTENDED RELEASE405

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-219-01EA - Each36800-219278b9019-f7e2-4f9f-b785-539e3c190eb712024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-219TOPCARE MUCUS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 4 package rows20230603_c12c68c3-c1bf-45dd-a311-fe1005189ec1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNc12c68c3-c1bf-45dd-a311-fe1005189ec15
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDc12c68c3-c1bf-45dd-a311-fe1005189ec15
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYc12c68c3-c1bf-45dd-a311-fe1005189ec15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-219-01368000219011 BOTTLE in 1 CARTON (36800-219-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent
36800-219-49368000219491 BOTTLE in 1 CARTON (36800-219-49) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2022-04-130000-00-00NoNoCurrent