FDA.reportPublic FDA data

Guaifenesin

Product NDC
73581-400
11-digit product format
735810400
Labeler code
73581
Product ID
73581-400_4cb11551-31e4-5c01-e063-6394a90ab0d4
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
YYBA CORP
Application
ANDA209215
Marketing category
ANDA
Marketing start
2026-03-10
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
Guaifenesin
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
73581-400-02Guaifenesin1 in 1 BOTTLETABLET11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN4cb11551-31e3-5c01-e063-6394a90ab0d41
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD4cb11551-31e3-5c01-e063-6394a90ab0d41
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY4cb11551-31e3-5c01-e063-6394a90ab0d41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73581-400-02735810400021 TABLET in 1 BOTTLE (73581-400-02) 1 tablet2026-03-10NoNoCurrent