FDA.reportPublic FDA data

MULTI-SYMPTOM DAYTIME

Product NDC
68210-4134
11-digit product format
682104134
Labeler code
68210
Product ID
68210-4134_ee8bbc19-04e2-21ba-e053-2995a90a0faf
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
SPIRIT PHARMACEUTICALS LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-04-28
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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 productproduct68210-4134IInactivated by FDA2026-10-15
excluded packagepackage68210-413468210-4134-1IInactivated by FDA2026-10-15

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
68210-4134-1MULTI-SYMPTOM DAYTIME1 in 1 CARTONCAPSULE, LIQUID FILLED15
68210-4134-1MULTI-SYMPTOM DAYTIME10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4134MULTI-SYMPTOM DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 2 package rows20241215_d642c0b0-baa0-4c3e-8b1d-cfe3b73382da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNd642c0b0-baa0-4c3e-8b1d-cfe3b73382da5
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDd642c0b0-baa0-4c3e-8b1d-cfe3b73382da5
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYd642c0b0-baa0-4c3e-8b1d-cfe3b73382da5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4134-1682104134011 BLISTER PACK in 1 CARTON (68210-4134-1) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2021-04-280000-00-00NoNoCurrent