FDA.reportPublic FDA data

Aspirin

Product NDC
50804-880
11-digit product format
508040880
Labeler code
50804
Product ID
50804-880_24c24cfb-3c06-b0f4-e063-6394a90a20d9
Type
HUMAN OTC DRUG
Nonproprietary name
ASPIRIN
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
GOODSENSE
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-01
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50804-88050804-880-13DDiscontinued by firm2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
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
662a2bc6-9507-465c-b467-7ae1b2e1dedcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
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
50804-880-01Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE14
50804-880-01Aspirin120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1204
50804-880-04Aspirin500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE5004
50804-880-13Aspirin500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-880-01EA - Each50804-880349917b7-a96e-4cbf-b0ba-f773eb89b45b12020-06-05
50804-880-04EA - Each50804-880e8a8a103-daa0-428e-a168-de710205184a12023-03-13
50804-880-13EA - Each50804-880eec1d18a-6fbc-485c-b198-960c5b2e085112019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-880ASPIRIN TABLET, DELAYED RELEASE [GOODSENSE]4Current NDC, Legacy NDC, 4 package rows20241020_662a2bc6-9507-465c-b467-7ae1b2e1dedc.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 1 of 85 · 1,687 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tension Headache Aspirin-FreeACETAMINOPHEN, CAFFEINERite Aid Corporation093a7c26-f2b1-4416-b193-81133d247d2e2026-08-06WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENKroger Companybc17b2e5-4828-6a2e-e053-2995a90a8c632026-08-05WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC997b9551-c222-4a9c-8ba1-09a5f97495fa2026-08-05WarningsExact identifier
application number: M013
Mantra Pain Gel raspberryACETAMINOPHENMOREMED INC.7c8bdf49-a6d2-4e42-b006-375f103fd0ac2026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETERd2d2846d-4e0b-4d42-b300-60dd3b2cca1b2026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETER960f5676-d8c5-470b-a663-4b8d152339b42026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETERa60f6439-2033-4bd2-b78c-6c083414a12b2026-08-05WarningsExact identifier
application number: M013
pain relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHARRIS TEETER0afb6181-d0b1-4845-8230-faabf1b997dc2026-08-05WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHarris Teeter8a3e3439-90ae-4fc9-8ff2-44b8363fa3382026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHarris Teeter50e7b939-e0eb-44ea-82ea-034e844e2c292026-08-05WarningsExact identifier
application number: M013
pain relief aspirin Low DoseASPIRINRite Aid Corporationdf7835c9-f10f-40c6-8955-61423d94b6772026-08-05WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENWinCo Foods, LLC4749a843-9c93-4edd-9b5f-a1e32666544e2026-08-04WarningsExact identifier
application number: M013
SurviveX Travel Med MODCONVENIENCE KITIntent Brands LLC522da86b-cfd7-dd20-e063-6394a90a51c62026-08-04WarningsExact identifier
application number: M013
Extra Strength Pain Reliever mini softgelsACETAMINOPHEN 500 MGShield Pharmaceuticals Corp0ebb1902-6f8a-4bfb-9f2e-839d43bfca372026-08-04WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENBetter Living Brands, LLC743af02c-c762-42f5-8e01-2f62da15e04e2026-08-04WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLC9aea8aae-8702-4c93-8b07-69cd252f44d62026-08-03WarningsExact identifier
application number: M013
Pain Relief Acetaminophen 325 mgACETAMINOPHENNUVICARE LLC49a59b79-b8b4-4bf5-a403-0a14751efc552026-08-03WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCd4e98f8e-f24c-4bdd-b750-fa4f877fb6212026-07-31WarningsExact identifier
application number: M013
KinderFarms Childrens Pain and FeverACETAMINOPHENKinderFarms, LLC4f86419a-b940-a9c6-e063-6394a90a6a2b2026-07-30WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFamily Dollar Stores, LLC53f7a9c8-f40e-19b2-e063-6394a90a86952026-07-29WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN77429b7f-78e4-42c0-8679-ae8da17488485
308416aspirin 81 MG Delayed Release Oral TabletSCD77429b7f-78e4-42c0-8679-ae8da17488485
308416ASA 81 MG Delayed Release Oral TabletSY77429b7f-78e4-42c0-8679-ae8da17488485
308416aspirin 81 MG Enteric Coated Oral TabletSY77429b7f-78e4-42c0-8679-ae8da17488485
308416aspirin 81 MG Delayed Release Oral TabletPSN662a2bc6-9507-465c-b467-7ae1b2e1dedc4
308416aspirin 81 MG Delayed Release Oral TabletSCD662a2bc6-9507-465c-b467-7ae1b2e1dedc4
308416ASA 81 MG Delayed Release Oral TabletSY662a2bc6-9507-465c-b467-7ae1b2e1dedc4
308416aspirin 81 MG Enteric Coated Oral TabletSY662a2bc6-9507-465c-b467-7ae1b2e1dedc4
308416aspirin 81 MG Delayed Release Oral TabletPSN5e3633ff-64a4-4a72-addc-a3babea040b53
308416aspirin 81 MG Delayed Release Oral TabletSCD5e3633ff-64a4-4a72-addc-a3babea040b53
308416ASA 81 MG Delayed Release Oral TabletSY5e3633ff-64a4-4a72-addc-a3babea040b53
308416aspirin 81 MG Enteric Coated Oral TabletSY5e3633ff-64a4-4a72-addc-a3babea040b53
308416aspirin 81 MG Delayed Release Oral TabletPSN7a91b1df-8d6d-4205-9822-bc4d800555f72
308416aspirin 81 MG Delayed Release Oral TabletPSN44b8c203-37c5-425e-9110-f7eb614f9c2d2
308416aspirin 81 MG Delayed Release Oral TabletSCD44b8c203-37c5-425e-9110-f7eb614f9c2d2
308416aspirin 81 MG Delayed Release Oral TabletSCD7a91b1df-8d6d-4205-9822-bc4d800555f72
308416ASA 81 MG Delayed Release Oral TabletSY44b8c203-37c5-425e-9110-f7eb614f9c2d2
308416ASA 81 MG Delayed Release Oral TabletSY7a91b1df-8d6d-4205-9822-bc4d800555f72
308416aspirin 81 MG Enteric Coated Oral TabletSY7a91b1df-8d6d-4205-9822-bc4d800555f72
308416aspirin 81 MG Enteric Coated Oral TabletSY44b8c203-37c5-425e-9110-f7eb614f9c2d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50804-880-01508040880011 BOTTLE, PLASTIC in 1 CARTON (50804-880-01) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2019-01-010000-00-00NoNoCurrent
50804-880-0450804088004500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (50804-880-04) 2021-07-100000-00-00NoNoCurrent
50804-880-1350804088013500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (50804-880-13) 2019-01-010000-00-00NoNoCurrent