Topco Mucus Relief

Product NDC
36800-226
11-digit product format
368000226
Labeler code
36800
Product ID
36800-226_201dbdbd-483f-46ee-8db2-e540d0b5cb9d
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Topco Associates, LLC
Application
ANDA209215
Marketing category
ANDA
Marketing start
2021-06-01
Substance
GUAIFENESIN
Active strength
600 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topco Mucus Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui636522

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
36800-226-16Topco Mucus Relief100 in 1 BOTTLETABLET, EXTENDED RELEASE1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-226TOPCO MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [TOPCO ASSOCIATES, LLC]2Current NDC, Legacy NDC, 1 package rows20221130_03c17c06-6919-4ef4-9d0a-4c039940c671.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN03c17c06-6919-4ef4-9d0a-4c039940c6713
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD03c17c06-6919-4ef4-9d0a-4c039940c6713
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY03c17c06-6919-4ef4-9d0a-4c039940c6713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-226-1636800022616100 TABLET, EXTENDED RELEASE in 1 BOTTLE (36800-226-16) 2021-06-010000-00-00NoNoCurrent