FDA.reportPublic FDA data

GUAIFENESIN AND DEXTROMETHORPHAN HBR

Product NDC
76162-032
11-digit product format
761620032
Labeler code
76162
Product ID
76162-032_e8ef8f3d-f17e-4ccb-b4e5-44f2de06c0e9
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN AND DEXTROMETHORPHAN HBR
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Application
ANDA206941
Marketing category
ANDA
Marketing start
2026-04-23
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GUAIFENESIN AND DEXTROMETHORPHAN HBR
Listing expiration
2027-12-31

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
76162-032-56GUAIFENESIN AND DEXTROMETHORPHAN HBR7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE72
76162-032-56GUAIFENESIN AND DEXTROMETHORPHAN HBR8 in 1 CARTONTABLET, EXTENDED RELEASE82

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN3a9737c0-e413-dfd1-e063-6294a90aaebd2
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD3a9737c0-e413-dfd1-e063-6294a90aaebd2
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY3a9737c0-e413-dfd1-e063-6294a90aaebd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-032-56761620032568 BLISTER PACK in 1 CARTON (76162-032-56) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK8 blister pack2026-04-23NoNoCurrent