FDA.reportPublic FDA data

Guaifenesin

Product NDC
58602-810
11-digit product format
586020810
Labeler code
58602
Product ID
58602-810_e6952325-704d-4774-847c-02a6feb77434
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA210453
Marketing category
ANDA
Marketing start
2019-10-21
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-810-12Guaifenesin40 in 1 BOTTLETABLET, EXTENDED RELEASE407
58602-810-12Guaifenesin1 in 1 CARTONTABLET, EXTENDED RELEASE17
58602-810-21Guaifenesin1 in 1 CARTONTABLET, EXTENDED RELEASE17
58602-810-21Guaifenesin100 in 1 BOTTLETABLET, EXTENDED RELEASE1007
58602-810-38Guaifenesin10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE107
58602-810-38Guaifenesin8 in 1 CARTONTABLET, EXTENDED RELEASE87
58602-810-73Guaifenesin1 in 1 CARTONTABLET, EXTENDED RELEASE17
58602-810-73Guaifenesin20 in 1 BOTTLETABLET, EXTENDED RELEASE207
58602-810-96Guaifenesin1 in 1 CARTONTABLET, EXTENDED RELEASE17
58602-810-96Guaifenesin20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE207
58602-810-97Guaifenesin2 in 1 CARTONTABLET, EXTENDED RELEASE27
58602-810-97Guaifenesin20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE207
58602-810-98Guaifenesin20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE207
58602-810-98Guaifenesin5 in 1 CARTONTABLET, EXTENDED RELEASE57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58602-810-97EA - Each58602-810de48e26f-a046-4003-ae9d-f749880526d112023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-810GUAIFENESIN TABLET, EXTENDED RELEASE [AUROHEALTH LLC]7Current NDC, Legacy NDC, 14 package rows20241102_e95b5292-cd6c-4737-9386-f9441fd1bc28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNe95b5292-cd6c-4737-9386-f9441fd1bc287
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDe95b5292-cd6c-4737-9386-f9441fd1bc287
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYe95b5292-cd6c-4737-9386-f9441fd1bc287

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-810-12586020810121 BOTTLE in 1 CARTON (58602-810-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2019-10-210000-00-00NoNoCurrent
58602-810-21586020810211 BOTTLE in 1 CARTON (58602-810-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2019-10-210000-00-00NoNoCurrent
58602-810-38586020810388 BLISTER PACK in 1 CARTON (58602-810-38) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK8 blister pack2022-12-07NoNoCurrent
58602-810-73586020810731 BOTTLE in 1 CARTON (58602-810-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2019-10-210000-00-00NoNoCurrent
58602-810-96586020810961 BLISTER PACK in 1 CARTON (58602-810-96) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2019-10-210000-00-00NoNoCurrent
58602-810-97586020810972 BLISTER PACK in 1 CARTON (58602-810-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2019-10-210000-00-00NoNoCurrent
58602-810-98586020810985 BLISTER PACK in 1 CARTON (58602-810-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK5 blister pack2019-10-210000-00-00NoNoCurrent