Tension Headache Relief

Product NDC
63868-030
Requested package NDC
63868-030-10
11-digit product format
638680030
Labeler code
63868
Product ID
63868-030_2e066720-ecd0-4661-8461-1ea5cb953b14
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2007-01-17
Marketing end
2023-03-23
Substance
ACETAMINOPHEN; CAFFEINE
Active strength
500 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63868-03063868-030-10DDiscontinued 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 (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
CAFFEINEACTIVE INGREDIENT3G6A5W338ETENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
CAFFEINEACTIVE MOIETY3G6A5W338ETENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KTENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ETENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UTENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-030-10638680030101 BOTTLE in 1 CARTON (63868-030-10) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2007-01-172023-03-23NoNoCurrent