Long Acting Cough Softgels

Product NDC
63868-824
11-digit product format
638680824
Labeler code
63868
Product ID
63868-824_403f812d-6d5a-425a-b7f1-f6f2400993a3
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-05-03
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

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
63868-824-20Long Acting Cough Softgels1 in 1 CARTONCAPSULE, LIQUID FILLED13
63868-824-20Long Acting Cough Softgels20 in 1 BOTTLECAPSULE, LIQUID FILLED203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-824-20EA - Each63868-824e9fa1f34-3894-44ab-8723-e56cf45eac1312022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-824LONG ACTING COUGH SOFTGELS (DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [CHAIN DRUG MARKETING ASSOCIATION, INC.]3Legacy NDC, 2 package rows20250101_9a31b331-fbd3-42de-836b-1c3bb305419b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090487dextromethorphan HBr 15 MG Oral CapsulePSN9a31b331-fbd3-42de-836b-1c3bb305419b3
1090487dextromethorphan hydrobromide 15 MG Oral CapsuleSCD9a31b331-fbd3-42de-836b-1c3bb305419b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-824-20638680824201 BOTTLE in 1 CARTON (63868-824-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-05-030000-00-00NoNoCurrent