FDA.reportPublic FDA data

Guaifenesin

Product NDC
58602-853
11-digit product format
586020853
Labeler code
58602
Product ID
58602-853_af251c56-1fce-46a6-bd52-cca3425b96f9
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA210453
Marketing category
ANDA
Marketing start
2020-08-13
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
58602-853-12Guaifenesin40 in 1 BOTTLETABLET, EXTENDED RELEASE405
58602-853-12Guaifenesin1 in 1 CARTONTABLET, EXTENDED RELEASE15
58602-853-21Guaifenesin100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
58602-853-21Guaifenesin1 in 1 CARTONTABLET, EXTENDED RELEASE15
58602-853-73Guaifenesin1 in 1 CARTONTABLET, EXTENDED RELEASE15
58602-853-73Guaifenesin20 in 1 BOTTLETABLET, EXTENDED RELEASE205
58602-853-96Guaifenesin20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE205
58602-853-96Guaifenesin1 in 1 CARTONTABLET, EXTENDED RELEASE15
58602-853-97Guaifenesin2 in 1 CARTONTABLET, EXTENDED RELEASE25
58602-853-97Guaifenesin20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE205
58602-853-98Guaifenesin20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE205
58602-853-98Guaifenesin5 in 1 CARTONTABLET, EXTENDED RELEASE55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-853GUAIFENESIN TABLET, EXTENDED RELEASE [AUROHEALTH LLC]5Current NDC, Legacy NDC, 12 package rows20231202_84117b6e-4eeb-42b0-90b1-331f70d5a175.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN84117b6e-4eeb-42b0-90b1-331f70d5a1755
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD84117b6e-4eeb-42b0-90b1-331f70d5a1755
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY84117b6e-4eeb-42b0-90b1-331f70d5a1755

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-853-12586020853121 BOTTLE in 1 CARTON (58602-853-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-08-130000-00-00NoNoCurrent
58602-853-21586020853211 BOTTLE in 1 CARTON (58602-853-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-08-130000-00-00NoNoCurrent
58602-853-73586020853731 BOTTLE in 1 CARTON (58602-853-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-08-130000-00-00NoNoCurrent
58602-853-96586020853961 BLISTER PACK in 1 CARTON (58602-853-96) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2020-08-130000-00-00NoNoCurrent
58602-853-97586020853972 BLISTER PACK in 1 CARTON (58602-853-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2020-08-130000-00-00NoNoCurrent
58602-853-98586020853985 BLISTER PACK in 1 CARTON (58602-853-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK5 blister pack2022-11-010000-00-00NoNoCurrent