FDA.reportPublic FDA data

Cold and Flu HBP

Product NDC
67091-426
11-digit product format
670910426
Labeler code
67091
Product ID
67091-426_f87608a4-3888-4ef4-94a7-ff16bc2fcb22
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine maleate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
WinCo Foods, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-09
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE
Active strength
325; 2 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold and Flu HBP
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
CHLORPHENIRAMINE MALEATE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, V1Q0O9OJ9Z
Rxcui1112864

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-426-20Cold and Flu HBP2 in 1 CARTONTABLET, FILM COATED23
67091-426-20Cold and Flu HBP10 in 1 BLISTER PACKTABLET, FILM COATED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-426COLD AND FLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WINCO FOODS, LLC]2Current NDC, 2 package rows20240828_f8c1f2b7-8b1b-49f2-a774-b3a38d31b10e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1112864acetaminophen 325 MG / chlorpheniramine maleate 2 MG Oral TabletPSNf8c1f2b7-8b1b-49f2-a774-b3a38d31b10e3
1112864acetaminophen 325 MG / chlorpheniramine maleate 2 MG Oral TabletSCDf8c1f2b7-8b1b-49f2-a774-b3a38d31b10e3
1112864APAP 325 MG / chlorpheniramine maleate 2 MG Oral TabletSYf8c1f2b7-8b1b-49f2-a774-b3a38d31b10e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67091-426-20670910426202 BLISTER PACK in 1 CARTON (67091-426-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2024-04-09NoNoCurrent