FDA.reportPublic FDA data

DRx Choice Long Acting Cough

Product NDC
68163-742
11-digit product format
681630742
Labeler code
68163
Product ID
68163-742_3feeda7d-5593-7fe8-e063-6394a90a50fe
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr
Dosage form
LIQUID
Route
ORAL
Labeler
RARITAN PHARMACEUTICALS
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-24
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/10mL
Pharmacologic classes
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
DRx Choice Long Acting Cough
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui1090496

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68163-742-04DRx Choice Long Acting Cough1 in 1 BOXLIQUID13
68163-742-04DRx Choice Long Acting Cough118 mL in 1 BOTTLE, PLASTICLIQUID1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68163-742DRX CHOICE LONG ACTING COUGH (DEXTROMETHORPHAN HBR) LIQUID [RARITAN PHARMACEUTICALS]2Current NDC, 2 package rows20241124_875b40bd-7955-4048-abbf-7f43d9ea3ac5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090496dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSN875b40bd-7955-4048-abbf-7f43d9ea3ac53
1090496dextromethorphan hydrobromide 3 MG/ML Oral SolutionSCD875b40bd-7955-4048-abbf-7f43d9ea3ac53
1090496dextromethorphan hydrobromide 15 MG per 5 ML Oral SolutionSY875b40bd-7955-4048-abbf-7f43d9ea3ac53
1090496dextromethorphan hydrobromide 30 MG per 10 ML Oral SolutionSY875b40bd-7955-4048-abbf-7f43d9ea3ac53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68163-742-04681630742041 BOTTLE, PLASTIC in 1 BOX (68163-742-04) / 118 mL in 1 BOTTLE, PLASTIC2023-04-24NoNoHistorical