Mucus Relief

Product NDC
72090-012
11-digit product format
720900012
Labeler code
72090
Product ID
72090-012_022e6fd9-1e64-4364-a117-67354fed2fa0
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Pioneer Life Sciences, 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
72090-012-01Mucus Relief100 in 1 BOTTLETABLET, EXTENDED RELEASE1001
72090-012-02Mucus Relief30 in 1 BOTTLETABLET, EXTENDED RELEASE301
72090-012-03Mucus Relief50 in 1 BOTTLETABLET, EXTENDED RELEASE501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNd635b228-a51f-42d9-885c-3cd566fd352b1
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDd635b228-a51f-42d9-885c-3cd566fd352b1
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYd635b228-a51f-42d9-885c-3cd566fd352b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72090-012-0172090001201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72090-012-01) 2025-12-04NoNoCurrent
72090-012-027209000120230 TABLET, EXTENDED RELEASE in 1 BOTTLE (72090-012-02) 2025-12-04NoNoCurrent
72090-012-037209000120350 TABLET, EXTENDED RELEASE in 1 BOTTLE (72090-012-03) 2025-12-04NoNoCurrent