MUCUS RELIEF

Product NDC
55681-301
11-digit product format
556810301
Labeler code
55681
Product ID
55681-301_4deb799b-66b2-ddb4-e063-6394a90acf05
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
TABLET
Route
ORAL
Labeler
TWIN MED LLC
Application
ANDA213420
Marketing category
ANDA
Marketing start
2022-03-02
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MUCUS RELIEF
Brand name suffix
GUAIFENESIN EXTENDED-RELEASE 600 mg
Listing expiration
2027-12-31

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
55681-301-01MUCUS RELIEFGUAIFENESIN EXTENDED-RELEASE 600 mg100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55681-301MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 MG (GUAIFENESIN) TABLET [TWIN MED LLC]2Current NDC, Legacy NDC, 1 package rows20240104_d9d13c67-51a1-aa79-e053-2995a90abdbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNd9d13c67-51a1-aa79-e053-2995a90abdbb3
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDd9d13c67-51a1-aa79-e053-2995a90abdbb3
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYd9d13c67-51a1-aa79-e053-2995a90abdbb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55681-301-0155681030101100 TABLET in 1 BOTTLE (55681-301-01) 100 tablet2022-03-020000-00-00NoNoCurrent