Home NDC 49348-140 Pain Reliever PM
Product NDC 49348-140
11-digit product format 493480140
Labeler code 49348
Product ID 49348-140_ec071142-75c0-4739-b415-7b5cb2e0ceed
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 2014-12-31
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500 mg/1; mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ 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 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK 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 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 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 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X 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 TALC INACTIVE INGREDIENT 7SEV7J4R1U 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 49348-140-09 49348014009 1 BOTTLE, PLASTIC in 1 BOX (49348-140-09) > 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2014-12-31 0000-00-00 No No Current 49348-140-10 49348014010 1 BOTTLE, PLASTIC in 1 BOX (49348-140-10) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2014-12-31 0000-00-00 No No Current