Enteric coated aspirin

Product NDC
50804-370
11-digit product format
508040370
Labeler code
50804
Product ID
50804-370_58fa2392-a275-49cd-990a-4fd75d84d86c
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Good Sense (Geiss, Destin & Dunn, Inc.)
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-08-22
Marketing end
2024-01-05
Substance
ASPIRIN
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 productproduct50804-370DDiscontinued by firm2026-10-12
excluded packagepackage50804-37050804-370-12DDiscontinued by firm2026-10-12

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50804-370-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50804-370-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50804-370-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50804-370-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50804-370-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50804-370-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50804-370-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50804-370-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50804-370-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50804-370-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50804-370-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50804-370-12557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50804-370-122021-10-15C16284748780-1ba0f9c33-2117-a910-e053-dadaa90a0b85DRUG FACTS
50804-370-122021-01-29C16284748780-1ba0f9c33-2117-a910-e053-dadaa90a0b85DRUG FACTS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-370-12EA - Each50804-370e252f505-e234-4c0e-ae18-6b94c3df6b3412017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
ASPIRINACTIVE MOIETYR16CO5Y76EENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
TALCINACTIVE INGREDIENT7SEV7J4R1UENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50804-370-12508040370121 BOTTLE, PLASTIC in 1 BOX (50804-370-12) > 125 TABLET, COATED in 1 BOTTLE, PLASTIC2011-08-222024-01-05NoNoCurrent