FDA.reportPublic FDA data

Cough Relief

Product NDC
68210-4240
11-digit product format
682104240
Labeler code
68210
Product ID
68210-4240_f112c36b-930e-47b5-e053-2995a90a5c97
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HBr
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-12-30
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
2024-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68210-4240IInactivated by FDA2026-10-05
excluded packagepackage68210-424068210-4240-6IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68210-4240-62026-01-29C16284748780-149896155-ac7c-586f-e063-e6dba90add90Cough Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4240-6Cough Relief1 in 1 CARTONCAPSULE, LIQUID FILLED14
68210-4240-6Cough Relief60 in 1 JARCAPSULE, LIQUID FILLED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4240COUGH RELIEF (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]4Legacy NDC, 2 package rows20241213_b00a92be-bb99-4991-bfe9-5e45af43c719.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090487dextromethorphan HBr 15 MG Oral CapsulePSNb00a92be-bb99-4991-bfe9-5e45af43c7194
1090487dextromethorphan hydrobromide 15 MG Oral CapsuleSCDb00a92be-bb99-4991-bfe9-5e45af43c7194

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4240-6682104240061 JAR in 1 CARTON (68210-4240-6) > 60 CAPSULE, LIQUID FILLED in 1 JAR1 jar2022-12-300000-00-00NoNoCurrent