FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan HBr

Product NDC
58602-871
11-digit product format
586020871
Labeler code
58602
Product ID
58602-871_cbe945ca-7eb6-4de5-99cf-ba323a091621
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
2021-02-24
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
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
58602-871-83Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE12
58602-871-83Guaifenesin and Dextromethorphan HBr10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-871GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLET, EXTENDED RELEASE [AUROHEALTH LLC]2Current NDC, Legacy NDC, 2 package rows20231202_a1921611-343c-4c2a-846d-c8de19dddab5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNa1921611-343c-4c2a-846d-c8de19dddab52
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDa1921611-343c-4c2a-846d-c8de19dddab52
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYa1921611-343c-4c2a-846d-c8de19dddab52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-871-83586020871831 BLISTER PACK in 1 CARTON (58602-871-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2021-02-240000-00-00NoNoCurrent