FDA.reportPublic FDA data

Non Drowsy DAYTIME and NIGHTTIME Sinus Congestion and Cough Relief

Product NDC
69842-824
11-digit product format
698420824
Labeler code
69842
Product ID
69842-824_cfbd9168-088f-063d-e053-2995a90ab0b6
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
Dosage form
KIT
Route
ORAL
Labeler
CVS PHARMACY, INC.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-08-25
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct69842-824IInactivated by FDA2026-10-12
excluded packagepackage69842-82469842-824-20IInactivated by FDA2026-10-12

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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-824-202023-12-14C16284748780-1f386c649-9fa3-0266-e053-dadaa90a7c1aCVS Health Non Drowsy Daytime and Nighttime Sinus Congestion and Cough Relief
69842-824-202023-01-30C16284748780-1f386c649-9fa3-0266-e053-dadaa90a7c1aCVS Health Non Drowsy Daytime and Nighttime Sinus Congestion and Cough Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-824-20Non Drowsy DAYTIME and NIGHTTIME Sinus Congestion and Cough Relief1 in 1 CARTONKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-824NON DROWSY DAYTIME AND NIGHTTIME SINUS CONGESTION AND COUGH RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) KIT [CVS PHARMACY, INC.]4Legacy NDC, 1 package rows20241220_7b221ca0-4320-45f6-80f6-9dbd13ff6bf6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634363{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCK7b221ca0-4320-45f6-80f6-9dbd13ff6bf64
26343631 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackPSN7b221ca0-4320-45f6-80f6-9dbd13ff6bf64
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN7b221ca0-4320-45f6-80f6-9dbd13ff6bf64
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN7b221ca0-4320-45f6-80f6-9dbd13ff6bf64
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD7b221ca0-4320-45f6-80f6-9dbd13ff6bf64
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD7b221ca0-4320-45f6-80f6-9dbd13ff6bf64
26343631 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackSY7b221ca0-4320-45f6-80f6-9dbd13ff6bf64
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY7b221ca0-4320-45f6-80f6-9dbd13ff6bf64
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY7b221ca0-4320-45f6-80f6-9dbd13ff6bf64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-824-20698420824201 KIT in 1 CARTON (69842-824-20) * 1 BLISTER PACK in 1 CARTON > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 kit2021-08-250000-00-00NoNoCurrent