FDA.reportPublic FDA data

Cabinet Cough Relief

Product NDC
68210-6010
Requested package NDC
68210-6010-2
11-digit product format
682106010
Labeler code
68210
Product ID
68210-6010_eeca595d-e4ee-21a2-e053-2a95a90a2c5c
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-10-28
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68210-601068210-6010-2IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68210-6010-22026-01-29C16284748780-149896155-a24c-586f-e063-e6dba90add90Cabinet Cough Relief
68210-6010-32026-01-29C16284748780-149896155-a24c-586f-e063-e6dba90add90Cabinet Cough Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-6010-2Cabinet Cough Relief50 in 1 PACKAGECAPSULE, LIQUID FILLED507
68210-6010-3Cabinet Cough Relief1 in 1 CARTONCAPSULE, LIQUID FILLED17
68210-6010-3Cabinet Cough Relief25 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-6010CABINET COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]7Legacy NDC, 3 package rows20241213_919c278a-5dc0-4fa8-bfab-2231d9c1a995.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090487dextromethorphan HBr 15 MG Oral CapsulePSN919c278a-5dc0-4fa8-bfab-2231d9c1a9957
1090487dextromethorphan hydrobromide 15 MG Oral CapsuleSCD919c278a-5dc0-4fa8-bfab-2231d9c1a9957

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68210-6010-26821060100250 CAPSULE, LIQUID FILLED in 1 PACKAGE (68210-6010-2) 2019-10-280000-00-00NoNoCurrent