Nighttime Cold and Flu Relief
Night-Time Cold & Flu Relief
Approved
Approval ID
e2271f60-aad0-4e85-b5b2-9340e815f88b
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 1, 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, Doxylamine Succinate, Dextromethorphan HBr
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code37835-522
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr
Product Specifications
Route of AdministrationORAL
Effective DateMarch 1, 2025
FDA Product Classification
INGREDIENTS (13)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 15 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB
DOXYLAMINE SUCCINATEActive
Quantity: 6.25 mg in 1 1
Code: V9BI9B5YI2
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT