Extra Strength Pain Reliever

Product NDC
68016-110
11-digit product format
680160110
Labeler code
68016
Product ID
68016-110_9aa07f0c-a2d2-2178-e053-2a95a90aa5d8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin, Caffeine
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2008-04-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength
250 mg/1; mg/1; 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 productproduct68016-110DDiscontinued by firm2026-10-05
excluded packagepackage68016-11068016-110-00DDiscontinued 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 packagepackage68016-110-00d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68016-110-00f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68016-110-002ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68016-110-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68016-110-00cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68016-110-00cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68016-110-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68016-110-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68016-110-000efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68016-110-00ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68016-110-00367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68016-110-00557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
ASPIRINACTIVE INGREDIENTR16CO5Y76EEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
CAFFEINEACTIVE INGREDIENT3G6A5W338EEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
ASPIRINACTIVE MOIETYR16CO5Y76EEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
CAFFEINEACTIVE MOIETY3G6A5W338EEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1