FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan HBr

Product NDC
58602-715
11-digit product format
586020715
Labeler code
58602
Product ID
58602-715_8102c39b-c419-433f-9946-7ef777d7c3ef
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
60; 1200 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 HYDROBROMIDE60 mg/1
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1099074

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
58602-715-05Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE113
58602-715-05Guaifenesin and Dextromethorphan HBr14 in 1 BOTTLETABLET, EXTENDED RELEASE1413
58602-715-06Guaifenesin and Dextromethorphan HBr6 in 1 CARTONTABLET, EXTENDED RELEASE613
58602-715-06Guaifenesin and Dextromethorphan HBr7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE713
58602-715-09Guaifenesin and Dextromethorphan HBr30 in 1 BOTTLETABLET, EXTENDED RELEASE3013
58602-715-09Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE113
58602-715-10Guaifenesin and Dextromethorphan HBr8 in 1 BLISTER PACKTABLET, EXTENDED RELEASE813
58602-715-10Guaifenesin and Dextromethorphan HBr6 in 1 CARTONTABLET, EXTENDED RELEASE613
58602-715-15Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE113
58602-715-15Guaifenesin and Dextromethorphan HBr60 in 1 BOTTLETABLET, EXTENDED RELEASE6013
58602-715-57Guaifenesin and Dextromethorphan HBr28 in 1 BOTTLETABLET, EXTENDED RELEASE2813
58602-715-57Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE113
58602-715-60Guaifenesin and Dextromethorphan HBr42 in 1 BOTTLETABLET, EXTENDED RELEASE4213
58602-715-60Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE113
58602-715-64Guaifenesin and Dextromethorphan HBr7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE713
58602-715-64Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE113
58602-715-65Guaifenesin and Dextromethorphan HBr7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE713
58602-715-65Guaifenesin and Dextromethorphan HBr2 in 1 CARTONTABLET, EXTENDED RELEASE213
58602-715-68Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE113
58602-715-68Guaifenesin and Dextromethorphan HBr38 in 1 BOTTLETABLET, EXTENDED RELEASE3813
58602-715-69Guaifenesin and Dextromethorphan HBr44 in 1 BOTTLETABLET, EXTENDED RELEASE4413
58602-715-69Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE113
58602-715-70Guaifenesin and Dextromethorphan HBr7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE713
58602-715-70Guaifenesin and Dextromethorphan HBr4 in 1 CARTONTABLET, EXTENDED RELEASE413

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-715GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLET, EXTENDED RELEASE [AUROHEALTH LLC]12Current NDC, Legacy NDC, 24 package rows20241008_d0b0ceb8-ef42-4baa-85b3-4d7d2e6f66b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNd0b0ceb8-ef42-4baa-85b3-4d7d2e6f66b713
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDd0b0ceb8-ef42-4baa-85b3-4d7d2e6f66b713
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYd0b0ceb8-ef42-4baa-85b3-4d7d2e6f66b713
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN3b5c5617-8499-7fc8-e063-6394a90aa86c2
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD3b5c5617-8499-7fc8-e063-6394a90aa86c2
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY3b5c5617-8499-7fc8-e063-6394a90aa86c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-715-05586020715051 BOTTLE in 1 CARTON (58602-715-05) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent
58602-715-06586020715066 BLISTER PACK in 1 CARTON (58602-715-06) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK6 blister pack2017-03-170000-00-00NoNoCurrent
58602-715-09586020715091 BOTTLE in 1 CARTON (58602-715-09) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent
58602-715-10586020715106 BLISTER PACK in 1 CARTON (58602-715-10) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK6 blister pack2017-03-170000-00-00NoNoCurrent
58602-715-15586020715151 BOTTLE in 1 CARTON (58602-715-15) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent
58602-715-57586020715571 BOTTLE in 1 CARTON (58602-715-57) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent
58602-715-60586020715601 BOTTLE in 1 CARTON (58602-715-60) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent
58602-715-64586020715641 BLISTER PACK in 1 CARTON (58602-715-64) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2017-03-170000-00-00NoNoCurrent
58602-715-65586020715652 BLISTER PACK in 1 CARTON (58602-715-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2017-03-170000-00-00NoNoCurrent
58602-715-68586020715681 BOTTLE in 1 CARTON (58602-715-68) / 38 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent
58602-715-69586020715691 BOTTLE in 1 CARTON (58602-715-69) / 44 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-03-170000-00-00NoNoCurrent
58602-715-70586020715704 BLISTER PACK in 1 CARTON (58602-715-70) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2017-03-170000-00-00NoNoCurrent