FDA.reportPublic FDA data

MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME

Product NDC
11822-1988
Requested package NDC
11822-1988-9
11-digit product format
118221988
Labeler code
11822
Product ID
11822-1988_f0b71e60-6bf0-5e2e-e053-2a95a90a3abd
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen Dextromethorphan HBr Phenylephrine HCl and Acetominophen Dextromethorphan HBr Doxylamine Succinate
Dosage form
KIT
Labeler
RITE AID
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-09-15
Marketing end
0000-00-00
Active strength
0
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 packagepackage11822-198811822-1988-9IInactivated by FDA2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
11822-1988-02025-01-30C16284748780-12cef2736-a1dc-d83d-e063-dadaa90ab31f695T RITE AID 11822-1988 Multi-Symptom Cold & Flu Relief Daytime Nighttime (Acetaminophen 325mg Dextromethorphan HBr10mg Phenylephrine HCl 5mg Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine Succinate 6.25mg)
11822-1988-92025-01-30C16284748780-12cef2736-a1dc-d83d-e063-dadaa90ab31f695T RITE AID 11822-1988 Multi-Symptom Cold & Flu Relief Daytime Nighttime (Acetaminophen 325mg Dextromethorphan HBr10mg Phenylephrine HCl 5mg Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine Succinate 6.25mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1988-0MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME1 in 1 BLISTER PACKKIT12
11822-1988-0MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME2 in 1 CARTONKIT22
11822-1988-9MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME1 in 1 BLISTER PACKKIT12
11822-1988-9MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME4 in 1 CARTONKIT42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1988MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME (ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL AND ACETOMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE) KIT [RITE AID]2Legacy NDC, 4 package rows20221227_c95c4389-6684-05f3-e053-2a95a90a2267.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634564{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } PackGPCKc95c4389-6684-05f3-e053-2a95a90a22672
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSNc95c4389-6684-05f3-e053-2a95a90a22672
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNc95c4389-6684-05f3-e053-2a95a90a22672
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNc95c4389-6684-05f3-e053-2a95a90a22672
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDc95c4389-6684-05f3-e053-2a95a90a22672
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDc95c4389-6684-05f3-e053-2a95a90a22672
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSYc95c4389-6684-05f3-e053-2a95a90a22672
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYc95c4389-6684-05f3-e053-2a95a90a22672
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYc95c4389-6684-05f3-e053-2a95a90a22672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-1988-9118221988094 BLISTER PACK in 1 CARTON (11822-1988-9) > 1 KIT in 1 BLISTER PACK4 blister pack2021-09-150000-00-00NoNoCurrent