FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan HBr

Product NDC
58602-714
11-digit product format
586020714
Labeler code
58602
Product ID
58602-714_cfc45418-1bd2-4f68-b1c9-ed3f2bc006aa
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA206941
Marketing category
ANDA
Marketing start
2017-03-17
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
30; 600 mg/1; mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin and Dextromethorphan HBr
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/1
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1298324

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-714-03Guaifenesin and Dextromethorphan HBr10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1012
58602-714-05Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE112
58602-714-05Guaifenesin and Dextromethorphan HBr14 in 1 BOTTLETABLET, EXTENDED RELEASE1412
58602-714-07Guaifenesin and Dextromethorphan HBr6 in 1 CARTONTABLET, EXTENDED RELEASE612
58602-714-08Guaifenesin and Dextromethorphan HBr4 in 1 CARTONTABLET, EXTENDED RELEASE412
58602-714-09Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE112
58602-714-09Guaifenesin and Dextromethorphan HBr30 in 1 BOTTLETABLET, EXTENDED RELEASE3012
58602-714-12Guaifenesin and Dextromethorphan HBr40 in 1 BOTTLETABLET, EXTENDED RELEASE4012
58602-714-12Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE112
58602-714-15Guaifenesin and Dextromethorphan HBr60 in 1 BOTTLETABLET, EXTENDED RELEASE6012
58602-714-15Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE112
58602-714-66Guaifenesin and Dextromethorphan HBr58 in 1 BOTTLETABLET, EXTENDED RELEASE5812
58602-714-66Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE112
58602-714-67Guaifenesin and Dextromethorphan HBr2 in 1 CARTONTABLET, EXTENDED RELEASE212
58602-714-73Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE112
58602-714-73Guaifenesin and Dextromethorphan HBr20 in 1 BOTTLETABLET, EXTENDED RELEASE2012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58602-714-67EA - Each58602-714e9aea7b8-ce9e-461f-9e44-2cf997b74be712023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-714GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLET, EXTENDED RELEASE [AUROHEALTH LLC]12Current NDC, Legacy NDC, 16 package rows20241008_cc20129b-2556-4452-9222-afd503f1e7a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNcc20129b-2556-4452-9222-afd503f1e7a412
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDcc20129b-2556-4452-9222-afd503f1e7a412
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYcc20129b-2556-4452-9222-afd503f1e7a412
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN2f170b35-03a8-4d2e-a4ea-21cccf693d9e1
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD2f170b35-03a8-4d2e-a4ea-21cccf693d9e1
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY2f170b35-03a8-4d2e-a4ea-21cccf693d9e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-714-035860207140310 in 1 BLISTER PACKHistorical
58602-714-05586020714051 BOTTLE in 1 CARTON (58602-714-05) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent
58602-714-07586020714076 BLISTER PACK in 1 CARTON (58602-714-07) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (58602-714-03) 6 blister pack2017-03-170000-00-00NoNoCurrent
58602-714-08586020714084 BLISTER PACK in 1 CARTON (58602-714-08) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (58602-714-03) 4 blister pack2017-03-170000-00-00NoNoCurrent
58602-714-09586020714091 BOTTLE in 1 CARTON (58602-714-09) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent
58602-714-12586020714121 BOTTLE in 1 CARTON (58602-714-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent
58602-714-15586020714151 BOTTLE in 1 CARTON (58602-714-15) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent
58602-714-66586020714661 BOTTLE in 1 CARTON (58602-714-66) / 58 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent
58602-714-67586020714672 BLISTER PACK in 1 CARTON (58602-714-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (58602-714-03) 2 blister pack2017-03-170000-00-00NoNoCurrent
58602-714-73586020714731 BOTTLE in 1 CARTON (58602-714-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent