Pain Stoppers EX

Product NDC
0498-2521
Requested package NDC
0498-2521-50
11-digit product format
004982521
Labeler code
0498
Product ID
0498-2521_d2b86b09-9ed9-4e31-e053-2995a90a4af3
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Caffeine, Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Honeywell Safety Products USA, Inc
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-01-02
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CAFFEINE; ASPIRIN
Active strength
250 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage0498-25210498-2521-50DDiscontinued by firm2026-08-17

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…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN STOPPERS EXTRA (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED [NORTH SAFETY PRODUCTS LLC]1
ASPIRINACTIVE INGREDIENTR16CO5Y76EPAIN STOPPERS EXTRA (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED [NORTH SAFETY PRODUCTS LLC]1
CAFFEINEACTIVE INGREDIENT3G6A5W338EPAIN STOPPERS EXTRA (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED [NORTH SAFETY PRODUCTS LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN STOPPERS EXTRA (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED [NORTH SAFETY PRODUCTS LLC]1
ASPIRINACTIVE MOIETYR16CO5Y76EPAIN STOPPERS EXTRA (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED [NORTH SAFETY PRODUCTS LLC]1
CAFFEINEACTIVE MOIETY3G6A5W338EPAIN STOPPERS EXTRA (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED [NORTH SAFETY PRODUCTS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAIN STOPPERS EXTRA (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED [NORTH SAFETY PRODUCTS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPAIN STOPPERS EXTRA (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED [NORTH SAFETY PRODUCTS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAIN STOPPERS EXTRA (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED [NORTH SAFETY PRODUCTS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPAIN STOPPERS EXTRA (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED [NORTH SAFETY PRODUCTS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN STOPPERS EXTRA (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED [NORTH SAFETY PRODUCTS LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0498-2521-5000498252150500 PACKET in 1 BOX (0498-2521-50) > 2 TABLET, COATED in 1 PACKET (0498-2521-01) 500 packet2017-01-020000-00-00NoNoCurrent