Mucus Relief

Product NDC
61504-204
11-digit product format
615040204
Labeler code
61504
Product ID
61504-204_4409a979-9f87-3b38-e063-6394a90a8cf3
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AMERIFOODS TRADING COMPANY
Application
ANDA213420
Marketing category
ANDA
Marketing start
2025-11-20
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
61504-204-02Mucus Relief1 in 1 CARTONTABLET, EXTENDED RELEASE12
61504-204-02Mucus Relief14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE142

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN3802d63d-7dba-50de-e063-6294a90acf7b2
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD3802d63d-7dba-50de-e063-6294a90acf7b2
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY3802d63d-7dba-50de-e063-6294a90acf7b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61504-204-02615040204021 BLISTER PACK in 1 CARTON (61504-204-02) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2025-11-20NoNoHistorical