Multi-Symptom Cold and Flu

Product NDC
41520-068
11-digit product format
415200068
Labeler code
41520
Product ID
41520-068_c17ed978-d6a9-41a7-833e-07972ebb942f
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Care One (American Sales Company)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-07-31
Marketing end
2026-07-31
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Multi-Symptom Cold and Flu
Brand name suffix
DayTime

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ
Rxcui1086997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-068-24Multi-Symptom Cold and FluDayTime24 in 1 CARTONCAPSULE, LIQUID FILLED246
41520-068-24Multi-Symptom Cold and FluDayTime1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-068MULTI-SYMPTOM COLD AND FLU DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]5Current NDC, Legacy NDC, 2 package rows20231006_f9fad6a8-ed8f-45d9-b3d3-422c81f4b83a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNf9fad6a8-ed8f-45d9-b3d3-422c81f4b83a6
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDf9fad6a8-ed8f-45d9-b3d3-422c81f4b83a6
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYf9fad6a8-ed8f-45d9-b3d3-422c81f4b83a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-068-244152000682424 BLISTER PACK in 1 CARTON (41520-068-24) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK24 blister pack2016-07-312026-07-31NoNoCurrent