FDA.reportPublic FDA data

Adult Low Dose Enteric Coated Aspirin

Product NDC
57896-981
11-digit product format
578960981
Labeler code
57896
Product ID
57896-981_31bbe78b-8f42-4b51-e063-6294a90a4f51
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
81 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
Adult Low Dose Enteric Coated Aspirin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui308416

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
57896-981-01Adult Low Dose Enteric Coated Aspirin100 in 1 BOTTLETABLET, COATED1007
57896-981-10Adult Low Dose Enteric Coated Aspirin1000 in 1 BOTTLETABLET, COATED10007
57896-981-12Adult Low Dose Enteric Coated Aspirin120 in 1 BOTTLETABLET, COATED1207
57896-981-20Adult Low Dose Enteric Coated Aspirin200 in 1 BOTTLETABLET, COATED2007
57896-981-30Adult Low Dose Enteric Coated Aspirin300 in 1 BOTTLETABLET, COATED3007
57896-981-50Adult Low Dose Enteric Coated Aspirin500 in 1 BOTTLETABLET, COATED5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-981-01EA - Each57896-981a27fc58c-b6ba-404b-8692-81e83053868712013-02-13
57896-981-10EA - Each57896-9812ba797b8-4f6d-47a9-a1e6-1cfc7031fa1c12017-05-04
57896-981-12EA - Each57896-981f0f0d829-ac3d-4cea-bf55-9166def6b6f012016-03-04
57896-981-20EA - Each57896-98181ff5719-941d-4fe2-9cd5-77089991cde912022-03-09
57896-981-30EA - Each57896-981641fb666-6519-46d4-ae60-d435b7c86c1e12018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
ASPIRINACTIVE MOIETYR16CO5Y76EADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
SHELLACINACTIVE INGREDIENT46N107B71OADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
TRIACETININACTIVE INGREDIENTXHX3C3X673ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-981ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]7Current NDC, Legacy NDC, 6 package rows20250403_e327a52a-0e31-44b7-9823-7f60d070ae52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNe327a52a-0e31-44b7-9823-7f60d070ae527
308416aspirin 81 MG Delayed Release Oral TabletSCDe327a52a-0e31-44b7-9823-7f60d070ae527
308416ASA 81 MG Delayed Release Oral TabletSYe327a52a-0e31-44b7-9823-7f60d070ae527
308416aspirin 81 MG Enteric Coated Oral TabletSYe327a52a-0e31-44b7-9823-7f60d070ae527
308416aspirin 81 MG Delayed Release Oral TabletPSN61ecf3c9-42fa-4ae4-bd3b-694090477b9a4
308416aspirin 81 MG Delayed Release Oral TabletSCD61ecf3c9-42fa-4ae4-bd3b-694090477b9a4
308416ASA 81 MG Delayed Release Oral TabletSY61ecf3c9-42fa-4ae4-bd3b-694090477b9a4
308416aspirin 81 MG Enteric Coated Oral TabletSY61ecf3c9-42fa-4ae4-bd3b-694090477b9a4
308416aspirin 81 MG Delayed Release Oral TabletPSN1b5b8bb1-c45d-48f0-b275-9ce1f769fed43
308416aspirin 81 MG Delayed Release Oral TabletSCD1b5b8bb1-c45d-48f0-b275-9ce1f769fed43
308416ASA 81 MG Delayed Release Oral TabletSY1b5b8bb1-c45d-48f0-b275-9ce1f769fed43
308416aspirin 81 MG Enteric Coated Oral TabletSY1b5b8bb1-c45d-48f0-b275-9ce1f769fed43
308416aspirin 81 MG Delayed Release Oral TabletPSN324937c3-c558-bc79-e063-6294a90acc8e1
308416aspirin 81 MG Delayed Release Oral TabletPSNd3379569-7949-4f78-b634-5d4178b21ea41
308416aspirin 81 MG Delayed Release Oral TabletPSN2f74bc39-3bbe-ba0a-e063-6394a90aa3b21
308416aspirin 81 MG Delayed Release Oral TabletSCD324937c3-c558-bc79-e063-6294a90acc8e1
308416aspirin 81 MG Delayed Release Oral TabletSCDd3379569-7949-4f78-b634-5d4178b21ea41
308416aspirin 81 MG Delayed Release Oral TabletSCD2f74bc39-3bbe-ba0a-e063-6394a90aa3b21
308416ASA 81 MG Delayed Release Oral TabletSY324937c3-c558-bc79-e063-6294a90acc8e1
308416ASA 81 MG Delayed Release Oral TabletSYd3379569-7949-4f78-b634-5d4178b21ea41
308416ASA 81 MG Delayed Release Oral TabletSY2f74bc39-3bbe-ba0a-e063-6394a90aa3b21
308416aspirin 81 MG Enteric Coated Oral TabletSY324937c3-c558-bc79-e063-6294a90acc8e1
308416aspirin 81 MG Enteric Coated Oral TabletSY2f74bc39-3bbe-ba0a-e063-6394a90aa3b21
308416aspirin 81 MG Enteric Coated Oral TabletSYd3379569-7949-4f78-b634-5d4178b21ea41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57896-981-0157896098101100 TABLET, COATED in 1 BOTTLE (57896-981-01) 2012-12-010000-00-00NoNoCurrent
57896-981-10578960981101000 TABLET, COATED in 1 BOTTLE (57896-981-10) 2013-02-010000-00-00NoNoCurrent
57896-981-1257896098112120 TABLET, COATED in 1 BOTTLE (57896-981-12) 2012-12-010000-00-00NoNoCurrent
57896-981-2057896098120200 TABLET, COATED in 1 BOTTLE (57896-981-20) 2018-10-010000-00-00NoNoCurrent
57896-981-3057896098130300 TABLET, COATED in 1 BOTTLE (57896-981-30) 2013-01-010000-00-00NoNoCurrent
57896-981-5057896098150500 TABLET, COATED in 1 BOTTLE (57896-981-50) 2024-04-01NoNoHistorical