FDA.reportPublic FDA data

Daytime Nighttime Cold Flu Relief

Product NDC
21130-058
11-digit product format
211300058
Labeler code
21130
Product ID
21130-058_70be45e9-99a9-4f46-8a28-fddd8cabe3cf
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
Dosage form
KIT
Labeler
Safeway, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-30
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Daytime Nighttime Cold Flu Relief
Listing expiration
2026-12-31

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
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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21130-058-482020-11-19C16284748780-1ab0e2407-35f6-f274-e053-dbdaa90a6471DRUG FACTS
21130-058-482020-09-27C16284748780-1ab0e2407-35f6-f274-e053-dbdaa90a6471DRUG FACTS
21130-058-482020-09-25C16284748780-1ab0e2407-35f6-f274-e053-dbdaa90a6471DRUG FACTS
21130-058-482020-07-22C16284748780-1ab0e2407-35f6-f274-e053-dbdaa90a6471DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-058-48Daytime Nighttime Cold Flu Relief1 in 1 KITKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-058DAYTIME NIGHTTIME COLD FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SAFEWAY, INC.]5Current NDC, Legacy NDC, 1 package rows20240515_a8df5c04-0f92-4013-b3e5-2b45009a7b8d.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) } PackGPCKa8df5c04-0f92-4013-b3e5-2b45009a7b8d5
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) PackPSNa8df5c04-0f92-4013-b3e5-2b45009a7b8d5
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNa8df5c04-0f92-4013-b3e5-2b45009a7b8d5
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNa8df5c04-0f92-4013-b3e5-2b45009a7b8d5
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDa8df5c04-0f92-4013-b3e5-2b45009a7b8d5
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDa8df5c04-0f92-4013-b3e5-2b45009a7b8d5
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) PackSYa8df5c04-0f92-4013-b3e5-2b45009a7b8d5
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYa8df5c04-0f92-4013-b3e5-2b45009a7b8d5
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYa8df5c04-0f92-4013-b3e5-2b45009a7b8d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-058-48211300058481 KIT in 1 KIT (21130-058-48) * 16 BLISTER PACK in 1 CARTON / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 32 BLISTER PACK in 1 CARTON / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 kit2019-06-300000-00-00NoNoCurrent