FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan HBr

Product NDC
51660-301
11-digit product format
516600301
Labeler code
51660
Product ID
51660-301_500a94a0-fecd-696a-e063-6394a90a931f
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBr
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
OHM LABORATORIES INC
Application
ANDA214781
Marketing category
ANDA
Marketing start
2021-07-01
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
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 HYDROBROMIDE30 mg/1
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1298324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51660-301-21Guaifenesin and Dextromethorphan HBr1 in 1 CARTONTABLET, EXTENDED RELEASE14
51660-301-21Guaifenesin and Dextromethorphan HBr20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE204
51660-301-41Guaifenesin and Dextromethorphan HBr20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE204
51660-301-41Guaifenesin and Dextromethorphan HBr2 in 1 CARTONTABLET, EXTENDED RELEASE24
51660-301-61Guaifenesin and Dextromethorphan HBr20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE204
51660-301-61Guaifenesin and Dextromethorphan HBr3 in 1 CARTONTABLET, EXTENDED RELEASE34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-301GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLET, EXTENDED RELEASE [OHM LABORATORIES INC]2Current NDC, Legacy NDC, 6 package rows20210903_f2eb5494-2672-444f-afa3-d1ef8ed1eaa1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNf2eb5494-2672-444f-afa3-d1ef8ed1eaa14
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDf2eb5494-2672-444f-afa3-d1ef8ed1eaa14
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYf2eb5494-2672-444f-afa3-d1ef8ed1eaa14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51660-301-21516600301211 BLISTER PACK in 1 CARTON (51660-301-21) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2021-07-010000-00-00NoNoCurrent
51660-301-41516600301412 BLISTER PACK in 1 CARTON (51660-301-41) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2021-07-010000-00-00NoNoCurrent
51660-301-615166003016120 in 1 BLISTER PACKHistorical