Home NDC 68016-694-10 Tension Headache Relief
Product NDC 68016-694
Requested package NDC 68016-694-10
11-digit product format 680160694
Labeler code 68016
Product ID 68016-694_c4fc44bb-668e-468e-8bbf-7800905801df
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Caffeine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chain Drug Consortium
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 2022-12-31
Current FDA listing Historical FDA.report record 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM] 1 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM] 1 CAFFEINE ACTIVE MOIETY 3G6A5W338E TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM] 1 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68016-694-10 68016069410 1 BOTTLE in 1 CARTON (68016-694-10) > 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2007-01-17 0000-00-00 No No Current