FDA.reportPublic FDA data

Cold and Flu

Product NDC
0363-9011
11-digit product format
003639011
Labeler code
0363
Product ID
0363-9011_48c21d85-9f9f-6b2b-e063-6394a90a7472
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
Dosage form
KIT
Labeler
Walgreens
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-24
Marketing end
2026-11-30
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold and Flu
Brand name suffix
Daytime, Nighttime, Multi-Symptom

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1086997, 1094549, 2634564

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
0363-9011-242023-12-14C16284748780-1f386c64a-0748-0266-e053-dadaa90a7c1aWalgreens Non-Drowsy Daytime & Nighttime Cold and Flu
0363-9011-242023-01-30C16284748780-1f386c64a-0748-0266-e053-dadaa90a7c1aWalgreens Non-Drowsy Daytime & Nighttime Cold and Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9011-24Cold and FluDaytime, Nighttime, Multi-Symptom1 in 1 PACKAGE, COMBINATIONKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9011COLD AND FLU DAYTIME, NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [WALGREENS]5Current NDC, Legacy NDC, 1 package rows20250101_9862f84d-1c18-4ef7-86dc-98572599d417.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) } PackGPCK9862f84d-1c18-4ef7-86dc-98572599d4176
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) PackPSN9862f84d-1c18-4ef7-86dc-98572599d4176
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN9862f84d-1c18-4ef7-86dc-98572599d4176
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSN9862f84d-1c18-4ef7-86dc-98572599d4176
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD9862f84d-1c18-4ef7-86dc-98572599d4176
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD9862f84d-1c18-4ef7-86dc-98572599d4176
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) PackSY9862f84d-1c18-4ef7-86dc-98572599d4176
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY9862f84d-1c18-4ef7-86dc-98572599d4176
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY9862f84d-1c18-4ef7-86dc-98572599d4176

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9011-24003639011241 KIT in 1 PACKAGE, COMBINATION (0363-9011-24) * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 kit2021-08-242026-11-30NoNoCurrent