Allergy Plus Sinus Relief
Rite Aid 44-485
Approved
Approval ID
54623e2e-5f9a-426e-8f7e-ea755ff8b3f8
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 8, 2025
Manufacturers
FDA
Rite Aid Corporation
DUNS: 014578892
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diphenhydramine HCl and Phenylephrine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11822-0485
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Diphenhydramine HCl and Phenylephrine HCl
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2025
FDA Product Classification
INGREDIENTS (14)
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: TC2D6JAD40
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 04JA59TNSJ
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT