FDA.reportPublic FDA data

Regular Strength Enteric coated aspirin

Product NDC
57896-921
11-digit product format
578960921
Labeler code
57896
Product ID
57896-921_08a3b4e3-69e1-e206-e063-6294a90af268
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Geri-Care Pharmaceutical Corp
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-07-01
Substance
ASPIRIN
Active strength
325 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Regular Strength Enteric coated aspirin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui198467

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-921-01Regular Strength Enteric coated aspirin100 in 1 BOTTLETABLET, COATED1007
57896-921-10Regular Strength Enteric coated aspirin1000 in 1 BOTTLETABLET, COATED10007
57896-921-20Regular Strength Enteric coated aspirin200 in 1 BOTTLETABLET, COATED2007
57896-921-25Regular Strength Enteric coated aspirin250 in 1 BOTTLETABLET, COATED2507
57896-921-50Regular Strength Enteric coated aspirin500 in 1 BOTTLETABLET, COATED5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-921-01EA - Each57896-92185e28ed4-5f4a-4729-9eee-7495541b8dd012013-02-13
57896-921-10EA - Each57896-921ddb73921-57ff-4911-811f-c286a1afa91e12013-02-13
57896-921-20EA - Each57896-921bc2a2c79-e495-45ee-88aa-42972274687e12021-09-07
57896-921-25EA - Each57896-921fb41a51f-2871-4c12-9f25-43fecfa23c8a12018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
ASPIRINACTIVE INGREDIENTR16CO5Y76EREGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
ASPIRINACTIVE MOIETYR16CO5Y76EREGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UREGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GREGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OREGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8REGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357REGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOREGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656ASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEREGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AREGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW3REGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3REGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
SHELLACINACTIVE INGREDIENT46N107B71OREGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4REGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQREGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOREGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJREGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APREGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TALCINACTIVE INGREDIENT7SEV7J4R1UREGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPREGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TRIACETININACTIVE INGREDIENTXHX3C3X673REGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
TRIACETININACTIVE INGREDIENTXHX3C3X673ASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMREGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-921REGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]7Current NDC, Legacy NDC, 5 package rows20231027_c321208c-f192-42c5-9454-e0df5d02d685.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSNc321208c-f192-42c5-9454-e0df5d02d6857
198467aspirin 325 MG Delayed Release Oral TabletPSNbda805ab-7f37-405d-a144-4e06ad9a29a17
198467aspirin 325 MG Delayed Release Oral TabletSCDc321208c-f192-42c5-9454-e0df5d02d6857
198467aspirin 325 MG Delayed Release Oral TabletSCDbda805ab-7f37-405d-a144-4e06ad9a29a17
198467ASA 325 MG Delayed Release Oral TabletSYc321208c-f192-42c5-9454-e0df5d02d6857
198467ASA 325 MG Delayed Release Oral TabletSYbda805ab-7f37-405d-a144-4e06ad9a29a17
198467aspirin 325 MG Enteric Coated Oral TabletSYc321208c-f192-42c5-9454-e0df5d02d6857
198467aspirin 325 MG Enteric Coated Oral TabletSYbda805ab-7f37-405d-a144-4e06ad9a29a17
198467aspirin 325 MG Delayed Release Oral TabletPSNa0705f4f-55cb-214a-e053-2995a90aa6805
198467aspirin 325 MG Delayed Release Oral TabletSCDa0705f4f-55cb-214a-e053-2995a90aa6805
198467ASA 325 MG Delayed Release Oral TabletSYa0705f4f-55cb-214a-e053-2995a90aa6805
198467aspirin 325 MG Enteric Coated Oral TabletSYa0705f4f-55cb-214a-e053-2995a90aa6805
198467aspirin 325 MG Delayed Release Oral TabletPSNe1c8d0ed-da1d-4b1a-9a85-7b8532775f874
198467aspirin 325 MG Delayed Release Oral TabletSCDe1c8d0ed-da1d-4b1a-9a85-7b8532775f874
198467ASA 325 MG Delayed Release Oral TabletSYe1c8d0ed-da1d-4b1a-9a85-7b8532775f874
198467aspirin 325 MG Enteric Coated Oral TabletSYe1c8d0ed-da1d-4b1a-9a85-7b8532775f874
198467aspirin 325 MG Delayed Release Oral TabletPSN70f40469-c248-4c9d-bb13-30f9632ce3d73
198467aspirin 325 MG Delayed Release Oral TabletSCD70f40469-c248-4c9d-bb13-30f9632ce3d73
198467ASA 325 MG Delayed Release Oral TabletSY70f40469-c248-4c9d-bb13-30f9632ce3d73
198467aspirin 325 MG Enteric Coated Oral TabletSY70f40469-c248-4c9d-bb13-30f9632ce3d73
198467aspirin 325 MG Delayed Release Oral TabletPSNf8375029-e567-c6a5-e053-6394a90a5b672
198467aspirin 325 MG Delayed Release Oral TabletSCDf8375029-e567-c6a5-e053-6394a90a5b672
198467ASA 325 MG Delayed Release Oral TabletSYf8375029-e567-c6a5-e053-6394a90a5b672
198467aspirin 325 MG Enteric Coated Oral TabletSYf8375029-e567-c6a5-e053-6394a90a5b672
198467aspirin 325 MG Delayed Release Oral TabletPSNd1f05e56-c830-4f85-b685-2a5965d10a1c1
198467aspirin 325 MG Delayed Release Oral TabletPSN33733144-b26a-b4a3-e063-6294a90ae0491
198467aspirin 325 MG Delayed Release Oral TabletPSNe845538f-a83b-4650-8459-bc736efbad931
212033aspirin 325 MG Oral TabletPSN4f9bd0b1-0836-473d-bf08-b7894984dc591
198467aspirin 325 MG Delayed Release Oral TabletSCD33733144-b26a-b4a3-e063-6294a90ae0491
198467aspirin 325 MG Delayed Release Oral TabletSCDe845538f-a83b-4650-8459-bc736efbad931
198467aspirin 325 MG Delayed Release Oral TabletSCDd1f05e56-c830-4f85-b685-2a5965d10a1c1
212033aspirin 325 MG Oral TabletSCD4f9bd0b1-0836-473d-bf08-b7894984dc591
198467ASA 325 MG Delayed Release Oral TabletSY33733144-b26a-b4a3-e063-6294a90ae0491
198467ASA 325 MG Delayed Release Oral TabletSYe845538f-a83b-4650-8459-bc736efbad931
198467ASA 325 MG Delayed Release Oral TabletSYd1f05e56-c830-4f85-b685-2a5965d10a1c1
212033ASA 325 MG Oral TabletSY4f9bd0b1-0836-473d-bf08-b7894984dc591
198467aspirin 325 MG Enteric Coated Oral TabletSYe845538f-a83b-4650-8459-bc736efbad931
198467aspirin 325 MG Enteric Coated Oral TabletSYd1f05e56-c830-4f85-b685-2a5965d10a1c1
198467aspirin 325 MG Enteric Coated Oral TabletSY33733144-b26a-b4a3-e063-6294a90ae0491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57896-921-0157896092101100 TABLET, COATED in 1 BOTTLE (57896-921-01) 2012-12-010000-00-00NoNoCurrent
57896-921-10578960921101000 TABLET, COATED in 1 BOTTLE (57896-921-10) 2012-12-010000-00-00NoNoCurrent
57896-921-2057896092120200 TABLET, COATED in 1 BOTTLE (57896-921-20) 2018-08-010000-00-00NoNoCurrent
57896-921-2557896092125250 TABLET, COATED in 1 BOTTLE (57896-921-25) 2012-12-010000-00-00NoNoCurrent
57896-921-5057896092150500 TABLET, COATED in 1 BOTTLE (57896-921-50) 2012-12-010000-00-00NoNoCurrent