FDA.reportPublic FDA data

Night Time Cold and Flu Relief

Product NDC
69842-847
11-digit product format
698420847
Labeler code
69842
Product ID
69842-847_3e97e955-7fa0-4efb-a8f2-b1be22bfe03b
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-31
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
325; 15; 6.25 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Night Time Cold and Flu Relief
Brand name suffix
Multi Symptom
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1
DOXYLAMINE SUCCINATE6.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
Rxcui1094549

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-847-162020-10-27C16284748780-1ab0e2407-2615-f274-e053-dbdaa90a6471Drug Facts
69842-847-242020-10-27C16284748780-1ab0e2407-2615-f274-e053-dbdaa90a6471Drug Facts
69842-847-482020-10-27C16284748780-1ab0e2407-2615-f274-e053-dbdaa90a6471Drug Facts
69842-847-162020-09-27C16284748780-1ab0e2407-2615-f274-e053-dbdaa90a6471Drug Facts
69842-847-242020-09-27C16284748780-1ab0e2407-2615-f274-e053-dbdaa90a6471Drug Facts
69842-847-482020-09-27C16284748780-1ab0e2407-2615-f274-e053-dbdaa90a6471Drug Facts
69842-847-162020-09-25C16284748780-1ab0e2407-2615-f274-e053-dbdaa90a6471Drug Facts
69842-847-242020-09-25C16284748780-1ab0e2407-2615-f274-e053-dbdaa90a6471Drug Facts
69842-847-482020-09-25C16284748780-1ab0e2407-2615-f274-e053-dbdaa90a6471Drug Facts
69842-847-162020-07-22C16284748780-1ab0e2407-2615-f274-e053-dbdaa90a6471Drug Facts
69842-847-242020-07-22C16284748780-1ab0e2407-2615-f274-e053-dbdaa90a6471Drug Facts
69842-847-482020-07-22C16284748780-1ab0e2407-2615-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-847-16Night Time Cold and Flu ReliefMulti Symptom16 in 1 CARTONCAPSULE, LIQUID FILLED164
69842-847-16Night Time Cold and Flu ReliefMulti Symptom1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED14
69842-847-24Night Time Cold and Flu ReliefMulti Symptom24 in 1 CARTONCAPSULE, LIQUID FILLED244
69842-847-24Night Time Cold and Flu ReliefMulti Symptom1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED14
69842-847-48Night Time Cold and Flu ReliefMulti Symptom1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED14
69842-847-48Night Time Cold and Flu ReliefMulti Symptom48 in 1 CARTONCAPSULE, LIQUID FILLED484

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-847NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [CVS PHARMACY]4Current NDC, Legacy NDC, 6 package rows20241013_6c7b0ea6-bff9-4fd2-9e00-64015c326ee8.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 CapsulePSN6c7b0ea6-bff9-4fd2-9e00-64015c326ee84
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD6c7b0ea6-bff9-4fd2-9e00-64015c326ee84
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY6c7b0ea6-bff9-4fd2-9e00-64015c326ee84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-847-166984208471616 BLISTER PACK in 1 CARTON (69842-847-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK16 blister pack2019-03-310000-00-00NoNoCurrent
69842-847-246984208472424 BLISTER PACK in 1 CARTON (69842-847-24) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK24 blister pack2019-03-310000-00-00NoNoCurrent
69842-847-486984208474848 BLISTER PACK in 1 CARTON (69842-847-48) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK48 blister pack2019-03-310000-00-00NoNoCurrent