Home NDC 50804-060-50 Pain Relief PM
Product NDC 50804-060
Requested package NDC 50804-060-50
11-digit product format 508040060
Labeler code 50804
Product ID 50804-060_6088d277-ce31-4f6e-8e99-28915218cba8
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET, COATED
Route ORAL
Labeler Good Sense (Geiss, Destin & Dunn, Inc.)
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-08-31
Marketing end 2025-04-25
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50804-060 50804-060-50 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50804-060 50804-060-50 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50804-060-50 50804006050 1 BOTTLE, PLASTIC in 1 BOX (50804-060-50) > 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2015-08-31 2025-04-25 No No Current