Pain Reliever PM
Drug Facts
Approved
Approval ID
7a98d4d9-54e2-45c1-a76a-7f1907566e95
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 9, 2025
Manufacturers
FDA
Family Dollar (FAMILY WELLNESS)
DUNS: 024472631
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen, Diphenhydramine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55319-562
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Diphenhydramine HCl
Product Specifications
Route of AdministrationORAL
Effective DateApril 9, 2025
FDA Product Classification
INGREDIENTS (18)
ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: TC2D6JAD40
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT