FDA.reportPublic FDA data

MULTI-SYMPTOM NITETIME

Product NDC
68210-5005
Requested package NDC
68210-5005-1
11-digit product format
682105005
Labeler code
68210
Product ID
68210-5005_efa8ec56-54d2-559e-e053-2995a90a17e1
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
SPIRIT PHARMACEUTICALS LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-12-12
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
325 mg/1; mg/1; mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68210-500568210-5005-1IInactivated by FDA2026-10-16

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68210-5005-12026-01-29C16284748780-149896155-a7cd-586f-e063-e6dba90add90VALUMEDS MULTI-SYMPTOM NITE TIME COLD&FLU SOFTGELS
68210-5005-22026-01-29C16284748780-149896155-a7cd-586f-e063-e6dba90add90VALUMEDS MULTI-SYMPTOM NITE TIME COLD&FLU SOFTGELS
68210-5005-42026-01-29C16284748780-149896155-a7cd-586f-e063-e6dba90add90VALUMEDS MULTI-SYMPTOM NITE TIME COLD&FLU SOFTGELS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-5005-1MULTI-SYMPTOM NITETIME1 in 1 CARTONCAPSULE, LIQUID FILLED15
68210-5005-1MULTI-SYMPTOM NITETIME10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED105
68210-5005-2MULTI-SYMPTOM NITETIME2 in 1 CARTONCAPSULE, LIQUID FILLED25
68210-5005-2MULTI-SYMPTOM NITETIME12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED125
68210-5005-4MULTI-SYMPTOM NITETIME12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED125
68210-5005-4MULTI-SYMPTOM NITETIME4 in 1 CARTONCAPSULE, LIQUID FILLED45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-5005MULTI-SYMPTOM NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 6 package rows20241215_e107eac7-62d4-4b58-ae74-320705c4fdb6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNe107eac7-62d4-4b58-ae74-320705c4fdb65
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDe107eac7-62d4-4b58-ae74-320705c4fdb65
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYe107eac7-62d4-4b58-ae74-320705c4fdb65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-5005-1682105005011 BLISTER PACK in 1 CARTON (68210-5005-1) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2022-12-120000-00-00NoNoCurrent