FDA.reportPublic FDA data

good neighbor pharmacy mucus dm

Product NDC
46122-637
11-digit product format
461220637
Labeler code
46122
Product ID
46122-637_f0a64af6-a65d-4326-8166-2afca98cc546
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan HBr, guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA207602
Marketing category
ANDA
Marketing start
2020-01-08
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
good neighbor pharmacy mucus dm
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-637-03good neighbor pharmacy mucus dm28 in 1 BOTTLETABLET, EXTENDED RELEASE282
46122-637-03good neighbor pharmacy mucus dm1 in 1 CARTONTABLET, EXTENDED RELEASE12
46122-637-74good neighbor pharmacy mucus dm1 in 1 CARTONTABLET, EXTENDED RELEASE12
46122-637-74good neighbor pharmacy mucus dm14 in 1 BOTTLETABLET, EXTENDED RELEASE142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-637-74EA - Each46122-63714f57b37-780c-4e56-b6b5-90acf9ba40e212021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-637GOOD NEIGHBOR PHARMACY MUCUS DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, EXTENDED RELEASE [AMERISOURCE BERGEN]1Current NDC, Legacy NDC, 4 package rows20200123_f7925a6b-7029-4389-bf1b-8c0f5e79b950.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNf7925a6b-7029-4389-bf1b-8c0f5e79b9502
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDf7925a6b-7029-4389-bf1b-8c0f5e79b9502
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYf7925a6b-7029-4389-bf1b-8c0f5e79b9502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-637-03461220637031 BOTTLE in 1 CARTON (46122-637-03) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-01-080000-00-00NoNoCurrent
46122-637-74461220637741 BOTTLE in 1 CARTON (46122-637-74) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-01-080000-00-00NoNoCurrent