FDA.reportPublic FDA data

Topcare Mucus DM

Product NDC
36800-592
11-digit product format
368000592
Labeler code
36800
Product ID
36800-592_f8edf534-fdc9-4f15-95b8-26c0a651a48e
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan HBr, guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA207602
Marketing category
ANDA
Marketing start
2018-09-06
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
Topcare Mucus DM
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
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
36800-592-30Topcare Mucus DM28 in 1 BOTTLETABLET, EXTENDED RELEASE283
36800-592-30Topcare Mucus DM1 in 1 CARTONTABLET, EXTENDED RELEASE13
36800-592-66Topcare Mucus DM1 in 1 CARTONTABLET, EXTENDED RELEASE13
36800-592-66Topcare Mucus DM14 in 1 BOTTLETABLET, EXTENDED RELEASE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-592TOPCARE MUCUS DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]2Current NDC, Legacy NDC, 4 package rows20220817_60108084-4be9-4e8a-b354-9438e1694ebc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN60108084-4be9-4e8a-b354-9438e1694ebc3
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD60108084-4be9-4e8a-b354-9438e1694ebc3
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY60108084-4be9-4e8a-b354-9438e1694ebc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-592-30368000592301 BOTTLE in 1 CARTON (36800-592-30) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2022-07-290000-00-00NoNoCurrent
36800-592-66368000592661 BOTTLE in 1 CARTON (36800-592-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-09-060000-00-00NoNoCurrent