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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308416Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e327a52a-0e31-44b7-9823-7f60d070ae52Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 44 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin Low DoseASPIRINATLANTIC BIOLOGICALS CORP.024c5054-959f-4ea5-a71f-c0e16cc4b90c2025-06-24WarningsExact identifier
application number: M013
CHILDRENS ACETAMINOPHENCHILDRENS ACETAMINOPHEN ORALAARNA USA INC.38070d15-2678-4e59-e063-6294a90ab6902025-06-20WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENMorning Star OTC8502ea21-937d-4b33-a3e0-ffab5dc38cd82025-06-19WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEMorning Star OTC6cd07a01-7034-4994-bbd3-bedcdf7d5b832025-06-19WarningsExact identifier
application number: M013
DRX CHOICE Tension HeadacheACETAMINOPHEN, CAFFEINERaritan Pharmaceuticals Inc.8a5cb38b-669d-4177-b33b-d73c7ef48d182025-06-13WarningsExact identifier
application number: M013
good sense childrens pain and feverACETAMINOPHENNuCare Pharmaceuticals,Inc.3777f4fb-d279-199d-e063-6394a90acf362025-06-13WarningsExact identifier
application number: M013
Aspirina CafeinaASPIRIN,CAFFEINEBayer HealthCare LLC.2e709acc-325a-baca-e063-6394a90a24be2025-06-12WarningsExact identifier
application number: M013
AspirinASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.696f55b1-536c-40c4-91f7-b572c39220db2025-06-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS Pharmacy, Inc.6dea9e11-ff99-63c7-e053-2a91aa0a5b542025-06-10WarningsExact identifier
application number: M013
Children Acetaminophen Oral SolutionACETAMINOPHENMAJOR PHARMACEUTICALScfca5147-f390-40bd-8f13-c5b3b8d1c5b02025-06-09WarningsExact identifier
application number: M013
AspirinASPIRINTrifecta Pharmaceuticals USA LLC372be427-acbd-c10c-e063-6294a90a572d2025-06-09WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS Pharmacyd6c8118c-bf78-4194-9b14-8de33c3ecdb72025-06-06WarningsExact identifier
application number: M013
Dolo-NeuroBionACETAMINOPHENBENARD INDUSTRIES INCb8310770-84d1-4a6f-8e23-9974947f92f12025-06-04WarningsExact identifier
application number: M013
Menstrual Complete Maximum StrengthACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATERite Aid Corporation69bda7d7-8660-4e8d-b8ac-892a3b1f21242025-06-03WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENKinderFarms, LLCfb74e8f9-d72f-4681-90bd-df48364405b52025-06-01WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENP & L Development, LLCb815fcae-8bba-4737-ac10-29a32fb692752025-05-30WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENKinderFarms, LLC81cc4900-226b-4c49-ba9c-5747d2a501b12025-05-29WarningsExact identifier
application number: M013
good sense pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLBryant Ranch Prepacke08a7ab1-4b68-422a-97bd-2c53266339432025-05-29WarningsExact identifier
application number: M013
Acetaminophen GelcapsACETAMINOPHENKroger30d3f2d0-da35-7f6f-e063-6294a90a9c222025-05-23WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENGenexa Inc.fcffa7e6-145c-6bc0-e053-6294a90a47512025-05-23WarningsExact identifier
application number: M013

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) 2024-04-01NoNoCurrent