FDA.reportPublic FDA data

Cold and Flu

Product NDC
37835-526
11-digit product format
378350526
Labeler code
37835
Product ID
37835-526_153d107c-82d2-4523-87dc-68aa51eed589
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Bi-Mart
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-18
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 5 mg/15mL; mg/15mL; mg/15mL
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/15mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ
Rxcui1113705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37835-526-02Cold and FluDaytime355 mL in 1 BOTTLE, PLASTICSOLUTION35511
37835-526-30Cold and FluDaytime354 mL in 1 BOTTLE, PLASTICSOLUTION35411

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37835-526COLD AND FLU DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [BI-MART]10Current NDC, Legacy NDC, 2 package rows20250129_f27bb9d1-9880-41f6-b500-42cb5957052a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNf27bb9d1-9880-41f6-b500-42cb5957052a11
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDf27bb9d1-9880-41f6-b500-42cb5957052a11
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYf27bb9d1-9880-41f6-b500-42cb5957052a11
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYf27bb9d1-9880-41f6-b500-42cb5957052a11
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYf27bb9d1-9880-41f6-b500-42cb5957052a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37835-526-0237835052602355 mL in 1 BOTTLE, PLASTIC (37835-526-02) 355 ml2023-01-060000-00-00NoNoCurrent
37835-526-3037835052630354 mL in 1 BOTTLE, PLASTIC (37835-526-30) 354 ml2018-06-180000-00-00NoNoCurrent