Aspirin 81 mg
Aspirin 81mg EC
Approved
Approval ID
cce1e8bd-63c8-403a-bc32-e6788493f604
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 31, 2025
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code71335-1774
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Aspirin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2025
FDA Product Classification
INGREDIENTS (13)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ASPIRINActive
Quantity: 81 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT