FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan HBr

Product NDC
11673-267
11-digit product format
116730267
Labeler code
11673
Product ID
11673-267_b50d26f2-6f4d-4430-9f6c-4d10bc893e75
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Target Corporation
Application
ANDA206941
Marketing category
ANDA
Marketing start
2024-07-04
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
11673-267-05Guaifenesin and Dextromethorphan HBr14 in 1 BOTTLETABLET, EXTENDED RELEASE143
11673-267-05Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE13
11673-267-57Guaifenesin and Dextromethorphan HBr28 in 1 BOTTLETABLET, EXTENDED RELEASE283
11673-267-57Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE13
11673-267-60Guaifenesin and Dextromethorphan HBr42 in 1 BOTTLETABLET, EXTENDED RELEASE423
11673-267-60Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-267GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLET, EXTENDED RELEASE [TARGET CORPORATION]2Current NDC, 6 package rows20240709_15434143-ab8e-4cf9-e063-6394a90a2388.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN15434143-ab8e-4cf9-e063-6394a90a23883
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD15434143-ab8e-4cf9-e063-6394a90a23883
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY15434143-ab8e-4cf9-e063-6394a90a23883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11673-267-05116730267051 BOTTLE in 1 CARTON (11673-267-05) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2024-07-04NoNoCurrent
11673-267-57116730267571 BOTTLE in 1 CARTON (11673-267-57) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2024-07-04NoNoCurrent
11673-267-60116730267601 BOTTLE in 1 CARTON (11673-267-60) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2024-07-04NoNoCurrent