Mucus Relief

Product NDC
80513-403
11-digit product format
805130403
Labeler code
80513
Product ID
80513-403_20ccaea1-80da-f1df-e063-6394a90a7dda
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Advanced Rx LLC
Application
ANDA213420
Marketing category
ANDA
Marketing start
2020-05-08
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
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
80513-403-20Mucus Relief200 in 1 BOTTLETABLET, EXTENDED RELEASE2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80513-403MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [ADVANCED RX LLC]1Current NDC, 1 package rows20240830_6046a5c6-96b1-4c20-acac-2716025c1665.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN6046a5c6-96b1-4c20-acac-2716025c16651
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD6046a5c6-96b1-4c20-acac-2716025c16651
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY6046a5c6-96b1-4c20-acac-2716025c16651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80513-403-2080513040320200 TABLET, EXTENDED RELEASE in 1 BOTTLE (80513-403-20) 2024-08-29NoNoCurrent