Home NDC 55315-557 Pain Reliever PM
Product NDC 55315-557
11-digit product format 553150557
Labeler code 55315
Product ID 55315-557_6628f9c9-4b3e-4453-835a-ed8c7a55e852
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET
Route ORAL
Labeler FRED'S, INC.
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2007-12-17
Marketing end 2022-04-08
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500 mg/1; 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 55315-557-10 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 55315-557-10 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 55315-557-10 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 55315-557-10 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 55315-557-10 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 55315-557-10 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 55315-557-10 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 55315-557-10 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 55315-557-10 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 55315-557-10 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 55315-557-10 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 55315-557-10 557ba5c1ecfa…9c80585c8c6e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [FRED'S, INC.] 4 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [FRED'S, INC.] 4 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [FRED'S, INC.] 4 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [FRED'S, INC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [FRED'S, INC.] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [FRED'S, INC.] 4 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [FRED'S, INC.] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [FRED'S, INC.] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [FRED'S, INC.] 4 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [FRED'S, INC.] 4 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [FRED'S, INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [FRED'S, INC.] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [FRED'S, INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [FRED'S, INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [FRED'S, INC.] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [FRED'S, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [FRED'S, INC.] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55315-557-10 55315055710 1 BOTTLE, PLASTIC in 1 CARTON (55315-557-10) > 40 TABLET in 1 BOTTLE, PLASTIC 2007-12-17 2022-04-08 No No Current