TopCare Chest Congestion and Cough Relief

Product NDC
36800-988
11-digit product format
368000988
Labeler code
36800
Product ID
36800-988_7f841999-de83-4f30-bbd7-f369b7cf1cf6
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide / Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-12-07
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 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 Chest Congestion and Cough Relief
Brand name suffix
DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
GUAIFENESIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1147685

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
36800-988-50TopCare Chest Congestion and Cough ReliefDM1 in 1 CARTONTABLET14
36800-988-50TopCare Chest Congestion and Cough ReliefDM30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-988-50EA - Each36800-988e8b2ba53-c53f-4c8d-992f-83f11a2dd52912024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-988TOPCARE CHEST CONGESTION AND COUGH RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 2 package rows20241220_5a2d0464-038d-4c3f-b39e-ee9984fb383e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN5a2d0464-038d-4c3f-b39e-ee9984fb383e4
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD5a2d0464-038d-4c3f-b39e-ee9984fb383e4
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY5a2d0464-038d-4c3f-b39e-ee9984fb383e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-988-50368000988501 BOTTLE, PLASTIC in 1 CARTON (36800-988-50) / 30 TABLET in 1 BOTTLE, PLASTIC2010-01-280000-00-00NoNoCurrent