FDA.reportPublic FDA data

Daytime Severe Cold and Flu

Product NDC
63868-467
11-digit product format
638680467
Labeler code
63868
Product ID
63868-467_a31db29c-85f4-4b48-a5ad-66d4bd1e99ea
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
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
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63868-467IInactivated by FDA2026-10-20
excluded packagepackage63868-46763868-467-24IInactivated by FDA2026-10-20

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
63868-467-242026-01-29C16284748780-149896155-a747-586f-e063-e6dba90add90QC ® QUALITY CHOICE Severe DayTime Cold & Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-467-24Daytime Severe Cold and Flu2 in 1 CARTONCAPSULE, LIQUID FILLED22
63868-467-24Daytime Severe Cold and Flu12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-467-24EA - Each63868-46765adae47-2edb-4e56-b621-8baf6f4c244112022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-467DAYTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CHAIN DRUG MARKETING ASSOCIATION, INC.]2Legacy NDC, 2 package rows20250101_ed84f1a9-2b7c-4d55-884d-be13c58872db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSNed84f1a9-2b7c-4d55-884d-be13c58872db2
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDed84f1a9-2b7c-4d55-884d-be13c58872db2
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYed84f1a9-2b7c-4d55-884d-be13c58872db2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-467-24638680467242 BLISTER PACK in 1 CARTON (63868-467-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2022-05-030000-00-00NoNoCurrent