Mucus Relief

Product NDC
84324-026
11-digit product format
843240026
Labeler code
84324
Product ID
84324-026_26a2bcb8-efc1-4353-ae36-c81969d813ba
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NUVICARE LLC
Application
ANDA213420
Marketing category
ANDA
Marketing start
2025-12-16
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
84324-026-01Mucus Relief40 in 1 BOTTLETABLET, EXTENDED RELEASE401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNa6608a39-2023-4953-a7c3-1764a6b215a31
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDa6608a39-2023-4953-a7c3-1764a6b215a31
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYa6608a39-2023-4953-a7c3-1764a6b215a31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84324-026-018432400260140 TABLET, EXTENDED RELEASE in 1 BOTTLE (84324-026-01) 2025-12-16NoNoCurrent