Home NDC 68016-694 Tension Headache Relief
Product NDC 68016-694
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68016-694-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68016-694-10 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68016-694-10 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68016-694-10 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68016-694-10 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68016-694-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68016-694-10 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68016-694-10 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68016-694-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68016-694-10 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68016-694-10 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68016-694-10 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 in 1 BOTTLE 1 bottle 2007-01-17 0000-00-00 No No Current