Micro-Coated Aspirin

Product NDC
0536-3305
Requested package NDC
0536-3305-01
11-digit product format
005363305
Labeler code
0536
Product ID
0536-3305_aaa24daa-a412-157c-e053-2a95a90ad909
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Rugby Laboratories, Inc
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-09-21
Marketing end
0000-00-00
Substance
ASPIRIN
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0536-33050536-3305-01DDiscontinued by firm2026-10-15

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…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-3305-01EA - Each0536-33058391f77c-57ed-4e16-a66d-bd8f1959e74912012-07-24
0536-3305-10EA - Each0536-330588b9cf03-9f31-43e3-b029-2d43b82fc73112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPASPIRIN TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
ASPIRINACTIVE INGREDIENTR16CO5Y76EMICRO-COATED ASPIRIN (ASPIRIN) TABLET, COATED [RUGBY LABORATORIES, INC]1
ASPIRINACTIVE MOIETYR16CO5Y76EMICRO-COATED ASPIRIN (ASPIRIN) TABLET, COATED [RUGBY LABORATORIES, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMICRO-COATED ASPIRIN (ASPIRIN) TABLET, COATED [RUGBY LABORATORIES, INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MICRO-COATED ASPIRIN (ASPIRIN) TABLET, COATED [RUGBY LABORATORIES, INC]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WMICRO-COATED ASPIRIN (ASPIRIN) TABLET, COATED [RUGBY LABORATORIES, INC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MICRO-COATED ASPIRIN (ASPIRIN) TABLET, COATED [RUGBY LABORATORIES, INC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMICRO-COATED ASPIRIN (ASPIRIN) TABLET, COATED [RUGBY LABORATORIES, INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMICRO-COATED ASPIRIN (ASPIRIN) TABLET, COATED [RUGBY LABORATORIES, INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMICRO-COATED ASPIRIN (ASPIRIN) TABLET, COATED [RUGBY LABORATORIES, INC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-3305-0100536330501100 TABLET, COATED in 1 BOTTLE (0536-3305-01) 2020-07-170000-00-00NoNoCurrent