Tension Headache Relief

Product NDC
50844-428
Requested package NDC
50844-428-08
11-digit product format
508440428
Labeler code
50844
Product ID
50844-428_148ac1d3-7dcd-4ea7-a76d-973ec2ad43f6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2007-01-17
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CAFFEINE
Active strength
500 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage50844-42850844-428-08DDiscontinued by firm2026-10-12

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…

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 INGREDIENT362O9ITL9DTENSION HEADACHE RELIEF ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
CAFFEINEACTIVE INGREDIENT3G6A5W338ETENSION HEADACHE RELIEF ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTENSION HEADACHE RELIEF ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
CAFFEINEACTIVE MOIETY3G6A5W338ETENSION HEADACHE RELIEF ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTENSION HEADACHE RELIEF ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KTENSION HEADACHE RELIEF ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTENSION HEADACHE RELIEF ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TENSION HEADACHE RELIEF ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TENSION HEADACHE RELIEF ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TENSION HEADACHE RELIEF ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ETENSION HEADACHE RELIEF ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTENSION HEADACHE RELIEF ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTENSION HEADACHE RELIEF ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UTENSION HEADACHE RELIEF ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTENSION HEADACHE RELIEF ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50844-428-08508440428081 BOTTLE, PLASTIC in 1 CARTON (50844-428-08) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2007-01-170000-00-00NoNoCurrent