Pain Relief

Product NDC
15127-857
11-digit product format
151270857
Labeler code
15127
Product ID
15127-857_c09aa84e-0f31-49d1-a4f4-c085ee7d653c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin and caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L&R Distributors, Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1992-11-17
Marketing end
2021-08-03
Substance
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength
250 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct15127-857DDiscontinued by firm2026-10-05
excluded packagepackage15127-85715127-857-08DDiscontinued 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 packagepackage15127-857-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage15127-857-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage15127-857-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage15127-857-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage15127-857-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage15127-857-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage15127-857-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage15127-857-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage15127-857-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage15127-857-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage15127-857-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage15127-857-08557ba5c1ecfa…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
15127-857-08EA - Each15127-85785920941-0eb4-43d6-b629-d2e0bdbb50cc12017-05-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [L&R DISTRIBUTORS, INC.]3
ASPIRINACTIVE INGREDIENTR16CO5Y76EEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [L&R DISTRIBUTORS, INC.]3
CAFFEINEACTIVE INGREDIENT3G6A5W338EEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [L&R DISTRIBUTORS, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [L&R DISTRIBUTORS, INC.]3
ASPIRINACTIVE MOIETYR16CO5Y76EEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [L&R DISTRIBUTORS, INC.]3
CAFFEINEACTIVE MOIETY3G6A5W338EEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [L&R DISTRIBUTORS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [L&R DISTRIBUTORS, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [L&R DISTRIBUTORS, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [L&R DISTRIBUTORS, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [L&R DISTRIBUTORS, INC.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [L&R DISTRIBUTORS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [L&R DISTRIBUTORS, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [L&R DISTRIBUTORS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [L&R DISTRIBUTORS, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [L&R DISTRIBUTORS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [L&R DISTRIBUTORS, INC.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
15127-857-08151270857081 BOTTLE, PLASTIC in 1 CARTON (15127-857-08) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1992-11-172021-08-03NoNoCurrent