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 43 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Coated Aspirin ASPIRIN L.N.K. International, Inc. e077fe14-62bb-462b-bfa3-8a83c06c22f1 2025-07-11 Warnings Exact identifier application number: M013 EXTRA PAIN RELIEF ACETAMINOPHEN, ASPIRIN AND CAFFEINE TIME CAP LABS 59482917-f80b-4bed-9218-068b35366eb3 2025-07-11 Warnings Exact identifier application number: M013 Up and Up Childrens acetaminophen ACETAMINOPHEN Target Corporation 25a476a4-9969-49b3-94bf-b076bada4cea 2025-07-10 Warnings Exact identifier application number: M013 Tylenol Extra Strength Caplet ACETAMINOPHEN Jones Healthcare Group - Packaging Services, Inc fba711c1-4e69-49b0-8994-97c455aebcb2 2025-07-09 Warnings Exact identifier application number: M013 good sense pain relief ACETAMINOPHEN L. Perrigo Company af7ae548-38ad-41d5-b1cb-761cd2e386d3 2025-07-08 Warnings Exact identifier application number: M013 topcare pain relief ACETAMINOPHEN Topco Associates LLC 6aca88df-d3b5-4a60-b23b-1e66dc41ee7b 2025-07-08 Warnings Exact identifier application number: M013 equate childrens pain and fever ACETAMINOPHEN Wal-Mart Stores Inc f15037a5-4e43-4dd6-93b8-b37a1cc22cd6 2025-07-07 Warnings Exact identifier application number: M013 Childrens Acetaminophen Oral Liquid Grape Flavor ACETAMINOPHEN AARNA USA INC. 39347f5d-2d3c-0c23-e063-6294a90a3a46 2025-07-05 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Meijer Distribution Inc be841460-98b4-4448-a494-09ff161fd131 2025-07-02 Warnings Exact identifier application number: M013 Adult Low Dose Aspirin ASPIRIN Advanced Rx LLC ad0d6a5c-eee9-406c-8d7f-1df9b45f5340 2025-07-02 Warnings Exact identifier application number: M013 EXTRA STRENGHT HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE Lil' Drug Store Products, Inc. ec04eb5d-96c0-ddb4-e053-2a95a90a4a92 2025-07-02 Warnings Exact identifier application number: M013 Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE Genexa Inc. 18835205-a9e3-15c2-e063-6394a90a8107 2025-07-02 Warnings Exact identifier application number: M013 FeverAll ACETAMINOPHEN Sun Pharmaceutical Industries, Inc. 8970b91b-5f3c-4764-9e23-25dcb398d0a7 2025-07-02 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Meijer Distribution Inc 11c9712d-c3b2-49cd-9c2b-0f57190c954e 2025-07-02 Warnings Exact identifier application number: M013 Aspirin Regular Strength ASPIRIN United Natural Foods, Inc. dba UNFI 979973c1-661a-4384-8b92-fd901ebde558 2025-07-01 Warnings Exact identifier application number: M013 Pain and Fever Childrens ACETAMINOPHEN CVS Pharmacy f6bbce1c-9790-4ca4-847f-579c594ffe0b 2025-07-01 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREENS 07d2e322-2465-79e5-e063-6294a90a5ea4 2025-06-30 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART 66c0cf26-357b-4722-9100-3b86d507a8cd 2025-06-30 Warnings Exact identifier application number: M013 ALLERGY DIPHENHYDRAMINE HYDROCHLORIDE Kroger Company bc019c9e-8fac-5fd3-e053-2a95a90a7ccd 2025-06-25 Warnings Exact identifier application number: M013 ACETAMINOPHEN Extra Strength ACETAMINOPHEN TIME CAP LABS INC fd24d0e0-4f36-42d3-9149-2fb957690305 2025-06-25 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