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 46 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RIGHT REMEDIES LOW DOSE Aspirin 81mg ASPIRIN Strive Pharmaceuticals Inc. 322c0e50-cf75-51ab-e063-6294a90a9235 2025-04-14 Warnings Exact identifier application number: M013 Bayer Aspirin Regimen Chewable Low Dose Aspirin Orange ASPIRIN Bayer HealthCare LLC. 0c6ae05f-760f-34d1-e054-00144ff88e88 2025-04-11 Warnings Exact identifier application number: M013 Arthriten Inflammatory Pain Formula ACETAMINOPHEN, ASPIRIN, CAFFEINE Kobayashi Healthcare International, Inc c280ca89-4fb5-4050-90ee-d706a550a1ef 2025-04-11 Warnings Exact identifier application number: M013 Bayer Back and Body Extra Strength ASPIRIN,CAFFEINE Bayer HealthCare LLC. 0c77c484-6caf-12ca-e054-00144ff88e88 2025-04-10 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN NuCare Pharmaceuticals, Inc. 324937c3-c558-bc79-e063-6294a90acc8e 2025-04-08 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN 500MG CVS Pharmacy, Inc. 1fde6487-6682-99a3-e063-6294a90a3670 2025-04-04 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack bdc466c9-d9ae-4293-b7ea-46fb517661c6 2025-04-01 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN Geri-Care Pharmaceutical Corp e327a52a-0e31-44b7-9823-7f60d070ae52 2025-04-01 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Proficient Rx LP 9af5ccc8-aac0-4339-a9f6-58fdc9b91c57 2025-04-01 Warnings Exact identifier application number: M013 ASPIRIN 325 MG EC ASPIRIN Bryant Ranch Prepack 9d0449d2-c0c6-4e74-931b-35dc62584028 2025-03-31 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN Bryant Ranch Prepack cce1e8bd-63c8-403a-bc32-e6788493f604 2025-03-31 Warnings Exact identifier application number: M013 Adwe Feverx Acetaminophen Caplets, 500 mg Extra Strength ACETAMINOPHEN Aurex Laboratories Limited Liability Company 948c5826-6f35-484d-bb3f-cecf6a4b5c13 2025-03-31 Warnings Exact identifier application number: M013 Infants Pain and Fever ACETAMINOPHEN WALGREENS 281a530b-c759-50eb-e063-6394a90abb4f 2025-03-28 Warnings Exact identifier application number: M013 Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL WR Group, Inc. 8281771c-485c-42a9-9a1c-9a7a4298c5b8 2025-03-28 Warnings Exact identifier application number: M013 Acetaminophen Regular strength ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. 4181efc2-d183-410c-b647-233444c57e32 2025-03-20 Warnings Exact identifier application number: M013 CounterAct Pain ACETAMINOPHEN Melaleuca, Inc. 7faf76b4-7f25-377d-e053-2a91aa0a19d4 2025-03-20 Boxed warning, Warnings Exact identifier application number: M013 Mejoral ACETAMINOPHEN, CAFFEINE OPMX LLC 0bccf571-fcb9-2dd5-e063-6294a90a5f16 2025-03-19 Warnings Exact identifier application number: M013 ARTRIFIN 24 CAPLETS ACETAMINOPHEN, ASPIRIN, CAFFEINE OPMX LLC e7f15c2b-a730-b54f-e053-2a95a90a3b3e 2025-03-19 Warnings Exact identifier application number: M013 Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL TARGET Corporation 1fc3806e-a5c4-4a6e-951b-dfbf9f5771f1 2025-03-17 Warnings Exact identifier application number: M013 Signature Select Effervescent Pain Relief ASPIRIN Safeway Inc. 304fca65-2867-c963-e063-6394a90a183f 2025-03-14 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