Sleep Aid
Drug Facts
Approved
Approval ID
4144b1a6-aeae-4560-a997-b07206d80350
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 24, 2025
Manufacturers
FDA
P & L Development, LLC
DUNS: 101896231
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diphenhydramine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49580-0314
Application NumberM010
Product Classification
M
Marketing Category
C200263
G
Generic Name
Diphenhydramine HCl
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2025
FDA Product Classification
INGREDIENTS (12)
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 30 mL
Code: TC2D6JAD40
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUM ANHYDROUSInactive
Code: I4807BK602
Classification: IACT
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6S
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYOXYL 40 STEARATE TYPE IInactive
Code: 13A4J4NH9I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT