Home NDC 42507-437 Pain Relief
Product NDC 42507-437
11-digit product format 425070437
Labeler code 42507
Product ID 42507-437_e51575cc-8d80-47d9-93b7-96c19ce5f4d3
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler HyVee Inc
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 1992-11-19
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500; 25 mg/1; mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes
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.
Additional Listing Data#
Finished product Yes
Brand name base Pain Relief
Brand name suffix PM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1092189 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC] 2 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC] 2 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC] 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 4 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gencare-Aspirin Low Dose Pain reliever (NSAID) ASPIRIN Pioneer Life Sciences, LLC 24d4f46a-c7a5-4e94-804f-1e307d8e8cfc 2026-08-09 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN DOLGENCORP, LLC b4064039-2345-4227-b83d-54dc13a838d3 2026-08-07 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN United Natural Foods, Inc. dba UNFI 87def9e0-0246-42cf-b8ea-2513d52e9f68 2026-08-07 Warnings Exact identifier application number: M013 berkley and jensen acetaminophen ACETAMINOPHEN BJWC dee57d73-73ac-48bb-b1da-9971f1ff21c4 2026-08-07 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Salado Sales, Inc. aef30709-f33d-48ff-b2d4-0639ffbd1ffd 2026-08-07 Warnings Exact identifier application number: M013 Aspirin ASPIRIN P & L Development, LLC 4cd74cec-a209-4e92-b853-fbe5c95f7678 2026-08-06 Warnings Exact identifier application number: M013 Tension Headache Aspirin-Free ACETAMINOPHEN, CAFFEINE Rite Aid Corporation 093a7c26-f2b1-4416-b193-81133d247d2e 2026-08-06 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN Kroger Company bc17b2e5-4828-6a2e-e053-2995a90a8c63 2026-08-05 Warnings Exact identifier application number: M013 Infants TYLENOL ACETAMINOPHEN Kenvue Brands LLC 997b9551-c222-4a9c-8ba1-09a5f97495fa 2026-08-05 Warnings Exact identifier application number: M013 Mantra Pain Gel raspberry ACETAMINOPHEN MOREMED INC. 7c8bdf49-a6d2-4e42-b006-375f103fd0ac 2026-08-05 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN HARRIS TEETER d2d2846d-4e0b-4d42-b300-60dd3b2cca1b 2026-08-05 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN HARRIS TEETER 960f5676-d8c5-470b-a663-4b8d152339b4 2026-08-05 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN HARRIS TEETER a60f6439-2033-4bd2-b78c-6c083414a12b 2026-08-05 Warnings Exact identifier application number: M013 pain relief PM ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE HARRIS TEETER 0afb6181-d0b1-4845-8230-faabf1b997dc 2026-08-05 Warnings Exact identifier application number: M013 Acetaminophen PM ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Harris Teeter 8a3e3439-90ae-4fc9-8ff2-44b8363fa338 2026-08-05 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Harris Teeter 50e7b939-e0eb-44ea-82ea-034e844e2c29 2026-08-05 Warnings Exact identifier application number: M013 pain relief aspirin Low Dose ASPIRIN Rite Aid Corporation df7835c9-f10f-40c6-8955-61423d94b677 2026-08-05 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN DOLGENCORP, LLC 7396c97e-8a51-4a21-8208-f13258b5285c 2026-08-05 Warnings Exact identifier application number: M013 Pain Relief Regular Strength ACETAMINOPHEN Rite Aid Corporation 3b5d4a5a-8c65-4db1-bf01-e8df6523f45a 2026-08-04 Warnings Exact identifier application number: M013 childrens acetaminophen ACETAMINOPHEN WinCo Foods, LLC 4749a843-9c93-4edd-9b5f-a1e32666544e 2026-08-04 Warnings Exact identifier application number: M013
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42507-437-71 42507043771 1 BOTTLE in 1 CARTON (42507-437-71) / 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 1992-11-19 No No Current