Mucus Relief

Product NDC
84324-034
11-digit product format
843240034
Labeler code
84324
Product ID
84324-034_e4832528-9f83-4a91-9c15-e8723e045187
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NUVICARE LLC
Application
ANDA213420
Marketing category
ANDA
Marketing start
2025-12-04
Substance
GUAIFENESIN
Active strength
1200 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
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621

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
84324-034-01Mucus Relief24 in 1 BOTTLETABLET, EXTENDED RELEASE241

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNd6734345-29a1-4356-a063-ff37ed4fbe9a1
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDd6734345-29a1-4356-a063-ff37ed4fbe9a1
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYd6734345-29a1-4356-a063-ff37ed4fbe9a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84324-034-018432400340124 TABLET, EXTENDED RELEASE in 1 BOTTLE (84324-034-01) 2025-12-04NoNoCurrent