Extra Strength Pain Relief

Product NDC
68016-029
Requested package NDC
68016-029-20
11-digit product format
680160029
Labeler code
68016
Product ID
68016-029_ed74927d-d5f0-279c-e053-2995a90add78
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2007-09-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage68016-02968016-029-20DDiscontinued 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 · 9 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…

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
68016-029-14EA - Each68016-029dd8b1c4a-a808-449b-8e4c-84408c96941312015-02-02
68016-029-20EA - Each68016-029a83ed7da-a56a-4832-8c0e-ee80b1ababcb12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-029-20680160029201 BOTTLE in 1 CARTON (68016-029-20) > 100 TABLET, COATED in 1 BOTTLE1 bottle2007-09-010000-00-00NoNoCurrent