FDA.reportPublic FDA data

RoboCough

Product NDC
71598-102
11-digit product format
715980102
Labeler code
71598
Product ID
71598-102_2b5aa9c1-8e0b-09ec-e063-6394a90a699d
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr
Dosage form
LIQUID
Route
ORAL
Labeler
DXM Pharmacuetical, Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/3mL
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
RoboCough
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui2002003

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71598-102-40RoboCough120 mL in 1 BOTTLELIQUID1201
71598-102-40RoboCough1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71598-102ROBOCOUGH (DEXTROMETHORPHAN HBR) LIQUID [DXM PHARMACUETICAL, INC.]1Current NDC, 2 package rows20250112_32fa7a09-8624-44c1-b9e4-8a8f0594292b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2002003dextromethorphan HBr 30 MG in 3 mL Oral SolutionPSN32fa7a09-8624-44c1-b9e4-8a8f0594292b1
2002003dextromethorphan hydrobromide 10 MG/ML Oral SolutionSCD32fa7a09-8624-44c1-b9e4-8a8f0594292b1
2002003dextromethorphan HBr 30 MG per 3 ML Oral SolutionSY32fa7a09-8624-44c1-b9e4-8a8f0594292b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71598-102-40715980102401 BOTTLE in 1 CARTON (71598-102-40) / 120 mL in 1 BOTTLE1 bottle2023-10-01NoNoHistorical