Theraflu Flu Relief Maximum Strength

Product NDC
0067-8161
11-digit product format
000678161
Labeler code
0067
Product ID
0067-8161_132b9415-743c-c981-e063-6394a90ae3de
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr and Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form
KIT
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-27
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Theraflu Flu Relief Maximum Strength
Brand name suffix
Daytime Nighttime Combo Pack
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui247324, 1098496, 2604579

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-8161-01Theraflu Flu Relief Maximum StrengthDaytime Nighttime Combo Pack1 in 1 CARTONKIT13
0067-8162-01Theraflu Flu Relief Maximum StrengthDaytime Nighttime Combo Pack20 in 1 BLISTER PACKTABLET2015 mg3
0067-8163-01Theraflu Flu Relief Maximum StrengthDaytime Nighttime Combo Pack20 in 1 BLISTER PACKTABLET20500 mg3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-8161THERAFLU FLU RELIEF MAXIMUM STRENGTH DAYTIME NIGHTTIME COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) KIT [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC, 3 package rows20240310_68d3e88a-d1be-410b-92a1-863903b3aa61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2604579{1 (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet) / 1 (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG Oral Tablet) } PackGPCK68d3e88a-d1be-410b-92a1-863903b3aa613
26045791 daytime (acetaminophen 500 MG / dextromethorphan HBr 15 MG Oral Tablet) / 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet) PackPSN68d3e88a-d1be-410b-92a1-863903b3aa613
1098496acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral TabletPSN68d3e88a-d1be-410b-92a1-863903b3aa613
247324acetaminophen 500 MG /dextromethorphan HBr 15 MG Oral TabletPSN68d3e88a-d1be-410b-92a1-863903b3aa613
1098496acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral TabletSCD68d3e88a-d1be-410b-92a1-863903b3aa613
247324acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG Oral TabletSCD68d3e88a-d1be-410b-92a1-863903b3aa613
26045791 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral Tablet) / 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 15 MG Oral Tablet) PackSY68d3e88a-d1be-410b-92a1-863903b3aa613
247324acetaminophen 500 MG /dextromethorphan HBr 15 MG Oral TabletSY68d3e88a-d1be-410b-92a1-863903b3aa613
1098496APAP 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral TabletSY68d3e88a-d1be-410b-92a1-863903b3aa613
247324APAP 500 MG / Dextromethorphan Hydrobromide 15 MG Oral TabletSY68d3e88a-d1be-410b-92a1-863903b3aa613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0067-8161-01000678161011 KIT in 1 CARTON (0067-8161-01) * 20 TABLET in 1 BLISTER PACK (0067-8162-01) * 20 TABLET in 1 BLISTER PACK (0067-8163-01) 1 kit2022-06-270000-00-00NoNoCurrent
0067-8162-010006781620120 in 1 BLISTER PACKHistorical
0067-8163-010006781630120 in 1 BLISTER PACKHistorical