Home NDC 15127-898 Pain Reliever
Product NDC 15127-898
11-digit product format 151270898
Labeler code 15127
Product ID 15127-898_60854e66-3acc-4b3a-ad38-f29c26dd6051
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET
Route ORAL
Labeler L&R Distributors, Inc.
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2007-12-17
Marketing end 2021-09-10
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAIN RELIEVER EXTRA STRENGTH PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [L&R DISTRIBUTORS, 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 15127-898-20 15127089820 1 BOTTLE in 1 CARTON (15127-898-20) > 20 TABLET in 1 BOTTLE 1 bottle 2007-12-17 2021-09-10 No No Current