FDA.reportPublic FDA data

Guaifenesin

Product NDC
58602-811
11-digit product format
586020811
Labeler code
58602
Product ID
58602-811_209f74eb-400d-40fe-943e-cecd8aec3a1d
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
1200 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
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621

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
58602-811-01Guaifenesin14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE148
58602-811-01Guaifenesin1 in 1 CARTONTABLET, EXTENDED RELEASE18
58602-811-02Guaifenesin2 in 1 CARTONTABLET, EXTENDED RELEASE28
58602-811-02Guaifenesin14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE148
58602-811-03Guaifenesin14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE148
58602-811-03Guaifenesin3 in 1 CARTONTABLET, EXTENDED RELEASE38
58602-811-05Guaifenesin14 in 1 BOTTLETABLET, EXTENDED RELEASE148
58602-811-05Guaifenesin1 in 1 CARTONTABLET, EXTENDED RELEASE18
58602-811-12Guaifenesin40 in 1 BOTTLETABLET, EXTENDED RELEASE408
58602-811-12Guaifenesin1 in 1 CARTONTABLET, EXTENDED RELEASE18
58602-811-21Guaifenesin100 in 1 BOTTLETABLET, EXTENDED RELEASE1008
58602-811-56Guaifenesin14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE148
58602-811-56Guaifenesin4 in 1 CARTONTABLET, EXTENDED RELEASE48
58602-811-57Guaifenesin1 in 1 CARTONTABLET, EXTENDED RELEASE18
58602-811-57Guaifenesin28 in 1 BOTTLETABLET, EXTENDED RELEASE288
58602-811-60Guaifenesin1 in 1 CARTONTABLET, EXTENDED RELEASE18
58602-811-60Guaifenesin42 in 1 BOTTLETABLET, EXTENDED RELEASE428
58602-811-64Guaifenesin1 in 1 CARTONTABLET, EXTENDED RELEASE18
58602-811-64Guaifenesin7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE78
58602-811-73Guaifenesin20 in 1 BOTTLETABLET, EXTENDED RELEASE208
58602-811-73Guaifenesin1 in 1 CARTONTABLET, EXTENDED RELEASE18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-811GUAIFENESIN TABLET, EXTENDED RELEASE [AUROHEALTH LLC]8Current NDC, Legacy NDC, 21 package rows20241102_c3533119-b307-4bad-8c79-254fea08402b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNc3533119-b307-4bad-8c79-254fea08402b8
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDc3533119-b307-4bad-8c79-254fea08402b8
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYc3533119-b307-4bad-8c79-254fea08402b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-811-01586020811011 BLISTER PACK in 1 CARTON (58602-811-01) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2019-10-210000-00-00NoNoCurrent
58602-811-02586020811022 BLISTER PACK in 1 CARTON (58602-811-02) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2019-10-210000-00-00NoNoCurrent
58602-811-03586020811033 BLISTER PACK in 1 CARTON (58602-811-03) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK3 blister pack2019-10-210000-00-00NoNoCurrent
58602-811-05586020811051 BOTTLE in 1 CARTON (58602-811-05) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2019-10-210000-00-00NoNoCurrent
58602-811-12586020811121 BOTTLE in 1 CARTON (58602-811-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2019-10-210000-00-00NoNoCurrent
58602-811-2158602081121100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-811-21) 2019-10-210000-00-00NoNoCurrent
58602-811-56586020811564 BLISTER PACK in 1 CARTON (58602-811-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2020-01-310000-00-00NoNoCurrent
58602-811-57586020811571 BOTTLE in 1 CARTON (58602-811-57) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2019-10-210000-00-00NoNoCurrent
58602-811-60586020811601 BOTTLE in 1 CARTON (58602-811-60) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2019-10-210000-00-00NoNoCurrent
58602-811-64586020811641 BLISTER PACK in 1 CARTON (58602-811-64) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2020-11-260000-00-00NoNoCurrent
58602-811-73586020811731 BOTTLE in 1 CARTON (58602-811-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2019-10-210000-00-00NoNoCurrent