Adult Low Dose Enteric Coated Aspirin
gc 981
Approved
Approval ID
2f74bc39-3bbe-ba0a-e063-6394a90aa3b2
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 3, 2025
Manufacturers
FDA
ST. MARY'S MEDICAL PARK PHARMACY
DUNS: 063050751
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Aspirin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60760-673
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Aspirin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2025
FDA Product Classification
INGREDIENTS (18)
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
ASPIRINActive
Quantity: 81 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT