Cough Relief

Product NDC
80513-311
11-digit product format
805130311
Labeler code
80513
Product ID
80513-311_2bd504ed-3944-e6ce-e063-6294a90aa3de
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Advanced Rx LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
15 mg/1
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
Cough Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui1090487

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80513-311-06Cough Relief60 in 1 BOTTLECAPSULE, LIQUID FILLED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80513-311COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [ADVANCED RX LLC]1Current NDC, 1 package rows20250117_297e10e3-e740-4434-91a2-2e5c54985d33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090487dextromethorphan HBr 15 MG Oral CapsulePSN297e10e3-e740-4434-91a2-2e5c54985d331
1090487dextromethorphan hydrobromide 15 MG Oral CapsuleSCD297e10e3-e740-4434-91a2-2e5c54985d331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80513-311-068051303110660 CAPSULE, LIQUID FILLED in 1 BOTTLE (80513-311-06) 2025-01-01NoNoCurrent