Enteric Coated Aspirin

Product NDC
0536-3313
11-digit product format
005363313
Labeler code
0536
Product ID
0536-3313_92e6edd3-1afe-4223-a2a8-fd538088c718
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Rugby Laboratories, Inc
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-09-20
Marketing end
0000-00-00
Substance
ASPIRIN
Active strength
325 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0536-3313DDiscontinued by firm2026-10-05
excluded packagepackage0536-33130536-3313-01DDiscontinued by firm2026-10-05
excluded packagepackage0536-33130536-3313-10DDiscontinued by firm2026-10-05

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 · 36 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 packagepackage0536-3313-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0536-3313-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-3313-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-3313-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-3313-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-3313-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-3313-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-3313-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-3313-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-3313-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-3313-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-3313-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-3313-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-3313-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-3313-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-3313-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-3313-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-3313-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-3313-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-3313-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-3313-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-3313-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-3313-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-3313-10557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-3313-01EA - Each0536-3313820d9d4f-924d-4c1c-8af2-c78aa259f98012012-07-24
0536-3313-10EA - Each0536-33136c36870f-b74a-4c64-8e9c-205f382905be12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
ASPIRINACTIVE INGREDIENTR16CO5Y76EENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
ASPIRINACTIVE MOIETYR16CO5Y76EENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
ASPIRINACTIVE MOIETYR16CO5Y76EENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [RUGBY LABORATORIES, INC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSNa0f84fac-3f7c-45c0-a2e8-ce39fb2bd6301
198467aspirin 325 MG Delayed Release Oral TabletSCDa0f84fac-3f7c-45c0-a2e8-ce39fb2bd6301
198467ASA 325 MG Delayed Release Oral TabletSYa0f84fac-3f7c-45c0-a2e8-ce39fb2bd6301
198467aspirin 325 MG Enteric Coated Oral TabletSYa0f84fac-3f7c-45c0-a2e8-ce39fb2bd6301