GUAIFENESIN

Product NDC
41415-996
11-digit product format
414150996
Labeler code
41415
Product ID
41415-996_358ef02e-b1e9-dfdc-e063-6394a90ad299
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Publix Super Markets, Inc
Application
ANDA209254
Marketing category
ANDA
Marketing start
2018-01-08
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
41415-996-20GUAIFENESIN20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE202
41415-996-20GUAIFENESIN1 in 1 CARTONTABLET, EXTENDED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41415-996GUAIFENESIN TABLET, EXTENDED RELEASE [PUBLIX SUPER MARKETS, INC]2Current NDC, Legacy NDC, 2 package rows20250522_435e627c-b4f4-4214-904a-7527aab32cbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN435e627c-b4f4-4214-904a-7527aab32cbf2
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD435e627c-b4f4-4214-904a-7527aab32cbf2
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY435e627c-b4f4-4214-904a-7527aab32cbf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41415-996-20414150996201 BLISTER PACK in 1 CARTON (41415-996-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2018-02-080000-00-00NoNoCurrent