FDA.reportPublic FDA data

Mucus Relief

Product NDC
57344-203
11-digit product format
573440203
Labeler code
57344
Product ID
57344-203_1acb86a4-a4a9-7ccc-e063-6294a90a67ed
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AAA Pharmaceutical, Inc.
Application
ANDA213420
Marketing category
ANDA
Marketing start
2024-02-01
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
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
57344-203-02Mucus Relief2 in 1 CARTONTABLET, EXTENDED RELEASE22
57344-203-02Mucus Relief10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57344-203MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [AAA PHARMACEUTICAL, INC.]2Current NDC, 2 package rows20240615_68d6b88a-85ed-414d-8369-c7cceb8e9780.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN68d6b88a-85ed-414d-8369-c7cceb8e97802
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD68d6b88a-85ed-414d-8369-c7cceb8e97802
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY68d6b88a-85ed-414d-8369-c7cceb8e97802

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57344-203-02573440203022 BLISTER PACK in 1 CARTON (57344-203-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2024-02-01NoNoHistorical