FDA.reportPublic FDA data

Cold and Flu

Product NDC
49035-193
11-digit product format
490350193
Labeler code
49035
Product ID
49035-193_dc9d7fab-eb2d-41d1-83f1-5d9031922c3f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-30
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
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold and Flu
Brand name suffix
Daytime
Listing expiration
2027-12-31

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 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
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-193-24Cold and FluDaytime1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED17
49035-193-24Cold and FluDaytime24 in 1 CARTONCAPSULE, LIQUID FILLED247
49035-193-48Cold and FluDaytime48 in 1 CARTONCAPSULE, LIQUID FILLED487
49035-193-48Cold and FluDaytime1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-193COLD AND FLU DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]5Current NDC, Legacy NDC, 4 package rows20240322_af35c833-316a-4d21-bd3a-9b71558cadbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNaf35c833-316a-4d21-bd3a-9b71558cadbf7
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDaf35c833-316a-4d21-bd3a-9b71558cadbf7
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYaf35c833-316a-4d21-bd3a-9b71558cadbf7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-193-244903501932424 BLISTER PACK in 1 CARTON (49035-193-24) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK24 blister pack2020-01-300000-00-00NoNoCurrent
49035-193-484903501934848 BLISTER PACK in 1 CARTON (49035-193-48) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK48 blister pack2020-01-300000-00-00NoNoCurrent