FDA.reportPublic FDA data

good neighbor pharmacy night time

Product NDC
46122-136
11-digit product format
461220136
Labeler code
46122
Product ID
46122-136_dbfe5d4a-69cf-49b2-8678-faca85167a7e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Amerisource Bergen
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-28
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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
good neighbor pharmacy night time
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
Rxcui1043400

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46122-136-342023-08-04C16284748780-10191ceaa-63a5-198a-e063-dbdaa90aec3eAmerisource Bergen Night Time Drug Facts
46122-136-402023-08-04C16284748780-10191ceaa-63a5-198a-e063-dbdaa90aec3eAmerisource Bergen Night Time Drug Facts
46122-136-342023-07-28C16284748780-10191ceaa-63a5-198a-e063-dbdaa90aec3eAmerisource Bergen Night Time Drug Facts
46122-136-402023-07-28C16284748780-10191ceaa-63a5-198a-e063-dbdaa90aec3eAmerisource Bergen Night Time Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-136-34good neighbor pharmacy night time237 mL in 1 BOTTLESOLUTION2379
46122-136-40good neighbor pharmacy night time355 mL in 1 BOTTLESOLUTION3559

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-136GOOD NEIGHBOR PHARMACY NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [AMERISOURCE BERGEN]8Current NDC, Legacy NDC, 2 package rows20250420_e2b5c27e-ca5f-4503-a3ce-c86e1d8070a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSNe2b5c27e-ca5f-4503-a3ce-c86e1d8070a79
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDe2b5c27e-ca5f-4503-a3ce-c86e1d8070a79
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYe2b5c27e-ca5f-4503-a3ce-c86e1d8070a79
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYe2b5c27e-ca5f-4503-a3ce-c86e1d8070a79
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYe2b5c27e-ca5f-4503-a3ce-c86e1d8070a79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-136-3446122013634237 mL in 1 BOTTLE (46122-136-34) 237 ml2012-09-140000-00-00NoNoCurrent
46122-136-4046122013640355 mL in 1 BOTTLE (46122-136-40) 355 ml2012-07-200000-00-00NoNoCurrent