GUAIFENESIN

Product NDC
30142-961
11-digit product format
301420961
Labeler code
30142
Product ID
30142-961_5b667b46-235a-4d9c-aea1-0ec8286e3bbc
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Kroger Company
Application
ANDA209254
Marketing category
ANDA
Marketing start
2022-04-28
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
GUAIFENESIN
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
30142-961-20GUAIFENESIN20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE203
30142-961-20GUAIFENESIN1 in 1 CARTONTABLET, EXTENDED RELEASE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-961GUAIFENESIN TABLET, EXTENDED RELEASE [KROGER COMPANY]3Current NDC, Legacy NDC, 2 package rows20220504_d1ffd899-2a2a-41c0-b0c0-7c42f8cabf8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNd1ffd899-2a2a-41c0-b0c0-7c42f8cabf8d3
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDd1ffd899-2a2a-41c0-b0c0-7c42f8cabf8d3
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYd1ffd899-2a2a-41c0-b0c0-7c42f8cabf8d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-961-20301420961201 BLISTER PACK in 1 CARTON (30142-961-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2022-04-280000-00-00NoNoCurrent