Daytime Cold and Flu Relief
Day-Time Cold & Flu Relief
Approved
Approval ID
84353861-2146-4107-8e82-8842cfc7ba08
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 3, 2025
Manufacturers
FDA
Bi-Mart
DUNS: 027630078
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code37835-520
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2025
FDA Product Classification
INGREDIENTS (13)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 10 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 04JA59TNSJ
Classification: ACTIM