Aspirin

Product NDC
0603-0168
11-digit product format
006030168
Labeler code
0603
Product ID
0603-0168_790dcb0e-fd16-ac79-e053-2a91aa0ab173
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET
Route
ORAL
Labeler
Qualitest Pharmaceutical, Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2009-11-03
Marketing end
0000-00-00
Substance
ASPIRIN
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0603-0168DDiscontinued by firm2026-10-05
excluded packagepackage0603-01680603-0168-21DDiscontinued 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 · 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 packagepackage0603-0168-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0603-0168-21f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0603-0168-212ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0603-0168-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0603-0168-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0603-0168-21cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0603-0168-21302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0603-0168-21ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0603-0168-210efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0603-0168-21ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0603-0168-21367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0603-0168-21557ba5c1ecfa…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
0603-0168-21EA - Each0603-0168635ae310-8eb9-4440-992a-2fa90307e47a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN TABLET [QUALITEST PHARMACEUTICAL, INC.]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN TABLET [QUALITEST PHARMACEUTICAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN TABLET [QUALITEST PHARMACEUTICAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN TABLET [QUALITEST PHARMACEUTICAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN TABLET [QUALITEST PHARMACEUTICAL, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN TABLET [QUALITEST PHARMACEUTICAL, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PASPIRIN TABLET [QUALITEST PHARMACEUTICAL, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PASPIRIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)INACTIVE INGREDIENTG4U024CQK6ASPIRIN TABLET [QUALITEST PHARMACEUTICAL, INC.]1
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)INACTIVE INGREDIENTG4U024CQK6ASPIRIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPASPIRIN TABLET [QUALITEST PHARMACEUTICAL, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPASPIRIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQASPIRIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQASPIRIN TABLET [QUALITEST PHARMACEUTICAL, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN TABLET [QUALITEST PHARMACEUTICAL, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN TABLET [QUALITEST PHARMACEUTICAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN TABLET [QUALITEST PHARMACEUTICAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212033aspirin 325 MG Oral TabletPSN3a3cd47e-1ee5-4e26-baa3-da2786c1a5951
212033aspirin 325 MG Oral TabletSCD3a3cd47e-1ee5-4e26-baa3-da2786c1a5951
212033ASA 325 MG Oral TabletSY3a3cd47e-1ee5-4e26-baa3-da2786c1a5951