FDA.reportPublic FDA data

Low Dose Aspirin

Product NDC
49035-563
11-digit product format
490350563
Labeler code
49035
Product ID
49035-563_ea158083-c7a0-4b01-aa1d-d0e41bdc5e70
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-05-01
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49035-56349035-563-27DDiscontinued by firm2026-10-16
excluded packagepackage49035-56349035-563-96DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0549035-563-96d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0549035-563-27d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2649035-563-96f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2649035-563-27f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3149035-563-272ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3149035-563-962ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2849035-563-27a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2849035-563-96a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2149035-563-27cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2149035-563-96cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1049035-563-27cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1049035-563-96cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3149035-563-27302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3149035-563-96302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2049035-563-27ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2049035-563-96ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1049035-563-270efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1049035-563-960efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0849035-563-27ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0349035-563-27367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0949035-563-27557ba5c1ecfa…9c80585c8c6e…

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
Low Dose Aspirin
Listing expiration
2027-12-31

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
093e0458-9975-456f-8950-8273c8890b3cAvailable 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
49035-563-11Low Dose Aspirin60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE6020
49035-563-11Low Dose Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE120
49035-563-13Low Dose Aspirin250 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE25020
49035-563-13Low Dose Aspirin2 in 1 CARTONTABLET, DELAYED RELEASE220
49035-563-14Low Dose Aspirin500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE50020
49035-563-17Low Dose Aspirin300 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE30020
49035-563-27Low Dose Aspirin32 in 1 BOTTLETABLET, DELAYED RELEASE3220
49035-563-27Low Dose Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE120
49035-563-32Low Dose Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE120
49035-563-32Low Dose Aspirin120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12020
49035-563-96Low Dose Aspirin250 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE25020
49035-563-96Low Dose Aspirin2 in 1 CARTONTABLET, DELAYED RELEASE220

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-563-11EA - Each49035-563ebec318f-1f12-41f5-a80f-930e60b07c7112023-04-07
49035-563-14EA - Each49035-563cd68088e-ceaf-4855-b61c-e4642386350512016-03-04
49035-563-17EA - Each49035-563f22db8dc-c419-4a04-98ef-288aa123113b12013-02-13
49035-563-32EA - Each49035-563245bd25d-686d-4f7d-80b2-d950025d481312013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76ELOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
ASPIRINACTIVE MOIETYR16CO5Y76ELOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656LOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
SHELLACINACTIVE INGREDIENT46N107B71OLOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOLOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
TALCINACTIVE INGREDIENT7SEV7J4R1ULOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMLOW DOSE ASPIRIN (ASPIRIN) TABLET [WAL-MART STORES INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-563LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [WAL-MART STORES INC]19Current NDC, Legacy NDC, 12 package rows20250519_093e0458-9975-456f-8950-8273c8890b3c.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 77 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCIPharmadel LLC0ab11691-5b29-55fc-e063-6394a90aa3282023-11-17WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions1e223faa-f6d0-4235-bc4c-6cfca84a5b0a2023-11-17WarningsExact identifier
application number: M013
SanaTos XACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC85b8ef3d-7318-7f3b-e053-2991aa0a07772023-11-14WarningsExact identifier
application number: M013
RIGHT REMEDIES EXTRA STRENGTH PM Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.8badbaad-eb35-4251-a779-00474819360d2023-11-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC09935a74-34b0-0e7c-e063-6294a90a7c832023-11-07WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6dd6396-93e9-1096-e053-6394a90af06d2023-11-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.eb644e9e-36dc-5f84-e053-2a95a90affa52023-11-02WarningsExact identifier
application number: M013
Good Sense Childrens Pain and FeverACETAMINOPHENProficient Rx LP46527b1f-7515-44ce-b5cb-9d24223b9af12023-11-01WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions12feb32b-4b8c-4b17-9e86-cb286457b0882023-11-01WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINEProficient Rx LPaf8b30a0-7a56-4557-8404-cc8059fcd6bc2023-11-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAMERIFOODS TRADING COMPANYf6dd387d-c768-9443-e053-6394a90aca142023-10-31WarningsExact identifier
application number: M013
ASPIRINASPIRINAMERIFOODS TRADING COMPANYf6cec280-17a5-5c5d-e053-6394a90a81aa2023-10-31WarningsExact identifier
application number: M013
Regular Strength AspirinASPIRINCARDINAL HEALTH, INC.8aaa82c6-b46b-25c5-e053-2a95a90a37932023-10-30WarningsExact identifier
application number: M013
SafeTynadolACETAMINOPHENSinew Pharma Inc.b956d527-7ea7-e084-e053-2a95a90a866d2023-10-28WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMagno-Humphries, Inc.9d2275c8-0c3d-d2b3-e053-2995a90a368e2023-10-27WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENMagno-Humphries, Inc.9d22bedb-9fb3-8421-e053-2a95a90acf4a2023-10-27WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENMagno-Humphries, Inc.9d22d642-8aaf-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
application number: M013
ENTERIC COATED ASPIRINASPIRINMagno-Humphries, Inc.a7c02378-4213-4e57-aca2-2437ad02f7862023-10-27WarningsExact identifier
application number: M013
ExtraprinACETAMINOPHEN, ASPIRIN, CAFFEINEMagno-Humphries, Inc.9d22cdc8-29c5-4273-e053-2a95a90ad0bf2023-10-27WarningsExact identifier
application number: M013
Regular Strength Enteric coated aspirinASPIRINGeri-Care Pharmaceutical Corpc321208c-f192-42c5-9454-e0df5d02d6852023-10-26WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN093e0458-9975-456f-8950-8273c8890b3c20
308416aspirin 81 MG Delayed Release Oral TabletSCD093e0458-9975-456f-8950-8273c8890b3c20
308416ASA 81 MG Delayed Release Oral TabletSY093e0458-9975-456f-8950-8273c8890b3c20
308416aspirin 81 MG Enteric Coated Oral TabletSY093e0458-9975-456f-8950-8273c8890b3c20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-563-11490350563111 BOTTLE, PLASTIC in 1 CARTON (49035-563-11) / 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-010000-00-00NoNoCurrent
49035-563-13490350563132 BOTTLE, PLASTIC in 1 CARTON (49035-563-13) / 250 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-012027-04-30NoNoCurrent
49035-563-1449035056314500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49035-563-14) 2011-05-010000-00-00NoNoCurrent
49035-563-1749035056317300 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49035-563-17) 2011-05-010000-00-00NoNoCurrent
49035-563-27490350563271 BOTTLE in 1 CARTON (49035-563-27) > 32 TABLET in 1 BOTTLE1 bottle2011-05-010000-00-00NoNoCurrent
49035-563-32490350563321 BOTTLE, PLASTIC in 1 CARTON (49035-563-32) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-010000-00-00NoNoCurrent
49035-563-96490350563962 BOTTLE in 1 CARTON (49035-563-96) > 250 TABLET in 1 BOTTLE2 bottle2011-05-010000-00-00NoNoCurrent