FDA.reportPublic FDA data

DEXTROMETHORPHAN HYDROBROMIDE

Product NDC
68210-0106
11-digit product format
682100106
Labeler code
68210
Product ID
68210-0106_ee8b53ae-4501-651f-e053-2a95a90ab4dd
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
2018-04-10
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68210-0106IInactivated by FDA2026-10-12
excluded packagepackage68210-010668210-0106-1IInactivated by FDA2026-10-12
excluded packagepackage68210-010668210-0106-2IInactivated by FDA2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-0106-1DEXTROMETHORPHAN HYDROBROMIDE15 in 1 BOTTLECAPSULE, LIQUID FILLED158
68210-0106-1DEXTROMETHORPHAN HYDROBROMIDE1 in 1 CARTONCAPSULE, LIQUID FILLED18
68210-0106-2DEXTROMETHORPHAN HYDROBROMIDE240 in 1 BOTTLECAPSULE, LIQUID FILLED2408
68210-0106-2DEXTROMETHORPHAN HYDROBROMIDE1 in 1 CARTONCAPSULE, LIQUID FILLED18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-0106DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]8Legacy NDC, 4 package rows20241215_ac4d581b-4f09-40a0-a75f-d23d9c6fc0b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090487dextromethorphan HBr 15 MG Oral CapsulePSNac4d581b-4f09-40a0-a75f-d23d9c6fc0b98
1090487dextromethorphan hydrobromide 15 MG Oral CapsuleSCDac4d581b-4f09-40a0-a75f-d23d9c6fc0b98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-0106-1682100106011 BOTTLE in 1 CARTON (68210-0106-1) > 15 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2018-04-100000-00-00NoNoCurrent
68210-0106-2682100106021 BOTTLE in 1 CARTON (68210-0106-2) > 240 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-03-120000-00-00NoNoCurrent
68210-0106-3682100106031 BOTTLE in 1 CARTON (68210-0106-3) > 60 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-03-120000-00-00NoNoCurrent