Home NDC 49348-151-09 Pain Reliever PM
Product NDC 49348-151
Requested package NDC 49348-151-09
11-digit product format 493480151
Labeler code 49348
Product ID 49348-151_ffeaff9a-5520-42c8-9bad-9b033264ad7e
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET, COATED
Route ORAL
Labeler Strategic Sourcing Services LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-07-31
Marketing end 2021-12-30
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 · 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 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49348-151-09 49348015109 1 BOTTLE, PLASTIC in 1 BOX (49348-151-09) > 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2015-07-31 2021-12-30 No No Current