Home NDC 55315-135 Pain Reliever
Product NDC 55315-135
11-digit product format 553150135
Labeler code 55315
Product ID 55315-135_6c6cb8bc-0e2e-4c54-ac57-61d16e2c8a2d
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET
Route ORAL
Labeler FRED'S, INC.
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2005-12-11
Marketing end 2022-04-08
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
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 55315-135-12 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 55315-135-12 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 55315-135-12 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 55315-135-12 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 55315-135-12 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 55315-135-12 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 55315-135-12 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 55315-135-12 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 55315-135-12 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 55315-135-12 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 55315-135-12 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 55315-135-12 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 EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [FRED'S, INC.] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [FRED'S, INC.] 2 DEXTROSE MONOHYDRATE INACTIVE INGREDIENT LX22YL083G EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [FRED'S, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [FRED'S, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [FRED'S, INC.] 2 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [FRED'S, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [FRED'S, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [FRED'S, INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55315-135-12 55315013512 1 BOTTLE in 1 CARTON (55315-135-12) > 100 TABLET in 1 BOTTLE 1 bottle 2005-12-11 2022-04-08 No No Current