Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride 500 mg; 25 mg Tablet, Coated, 100-count — NDC 83324-0085-01 package photo

Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride 500 mg; 25 mg Tablet, Coated, 100-count

by CHAIN DRUG MARKETING ASSOCIATION, INC. · 1 BOTTLE, PLASTIC in 1 CARTON (83324-085-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
NDC 83324-0085-01
🏷️ FDA NDC (as labeled) 83324-085-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0444 NADAC Per package$4.44 / 100 tablets Pack sizes2 compare ↓
Also comes in: 50 tablets 83324-0085-50
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 83324-085-01
Product NDC 83324-085
11-digit billing NDC 83324008501
RxCUI 1092189
UNII 362O9ITL9D, TC2D6JAD40
UPC 0635515954618
Application # M013
SPL Set ID 3ce5bbf2-d449-464e-abeb-5c26866d1ab5
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-04-29
Route ORAL
Dosage form TABLET, COATED
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
GCN Seq No 003699
GCN 70221
HICL code 001861
Ingredient (HICL) Acetaminophen/Diphenhydramine
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B5
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.2)
HIC3 code B5S
Therapeutic class — specific (HIC3) Analgesic, Non-Sal.- 1St Generation Antihistamine
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name QC PAIN RLF PM 25-500MG CAPLET
FDB brand name Pain Relief Pm
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 83324-085-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 83324-0085-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anilides class.

Drug family (ATC) Anilides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerCHAIN DRUG MARKETING ASSOCIATION, INC.
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code83324
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio122 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name QC PAIN RLF PM 25-500MG CAPLET Ingredient Acetaminophen/Diphenhydramine
🧪 What is this product?

This is an over-the-counter coated tablet taken by mouth that combines acetaminophen and diphenhydramine hydrochloride. Acetaminophen is typically used to reduce pain and fever, while diphenhydramine hydrochloride is an antihistamine commonly used to help promote sleep and reduce itching or allergy symptoms. This combination product is marketed as a nighttime pain reliever, intended for people who want pain relief along with sleep support. It is an OTC monograph drug, meaning it is marketed under FDA's established rules for this category of product.

Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color blue
ShapeOval
ImprintAAA;1031
Size17 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.044 $4.44 / 100 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.047 $0.044
▼ Down 5% over the last 9 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense pain relief pm extra strength 500 mg/1; 25 mg 00113-0437-71 L. 50 tablets $0.044 Availability likely
Acetaminophen PM 25 mg/1; 500 mg 00904-6731-51 Major 50 tablets $0.044 Availability likely
Extra Strength PM Pain Medicine 500 mg/1; 25 mg 46122-0799-69 Amerisource 50 tablets $0.044 Availability likely
Acetaminophen, Diphenhydramine Hydrochloride 500 mg/1; 25 mg 70000-0411-01 LEADER/ 24 tablets $0.044 Availability likely
Pain Reliever PM 500 mg/1; 25 mg 70677-1149-01 Strategic 50 tablets $0.044 Availability likely
Acetaminophen PM 500 mg/1; 25 mg 83324-0070-20 Chain 20 tablets $0.044 Availability likely
Pain Relief PM Extra Strength 500 mg/1; 25 mgthis 83324-0085-01 CHAIN 100 tablets $0.044 Availability likely
Pain Reliever PM 500 mg/1; 25 mg 83324-0166-50 QUALITY 50 tablets $0.044 Availability likely
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 62011-0420-01 Strategic 50 tablets $0.046 FDA listed +3%
Pain Relief PM Extra Strength 500 mg/1; 25 mg 63868-0325-50 Chain 50 tablets $0.046 FDA listed +3%
Pain Relief PM 500 mg/1; 25 mg 70677-0081-01 Strategic 100 tablets $0.046 FDA listed +3%
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 62011-0256-01 Strategic 50 tablets $0.047 FDA listed +6%
Panadol Pm 500 mg/1; 25 mg 00135-0608-01 Haleon 24 tablets FDA listed
Panadol Pm 500 mg/1; 25 mg 00135-7021-01 Haleon 2 tablets FDA listed
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 00363-0556-09 Walgreen 20 tablets FDA listed
Extra Strength NiteTime Pain Relief 25 mg/1; 500 mg 00363-0714-42 WALGREENS 24 tablets FDA listed
Extra Strength Nite-Time Pain Relief 500 mg/1; 25 mg 00363-0715-01 WALGREENS 100 tablets FDA listed
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 00363-0760-10 Walgreens 100 tablets FDA listed
Pain Reliever PM Extra strength 500 mg/1; 25 mg 00363-0863-10 Walgreens 100 tablets FDA listed
Pain Reliever PM 500 mg/1; 25 mg 00363-2035-08 Walgreen 24 tablets FDA listed
Extra Strength Pain Reliever Pm 500 mg/1; 25 mg 00363-9085-15 WALGREENS 15 tablets FDA listed
Acetaminophen Diphenhydramine HCL 500 mg/1; 25 mg 00363-9661-15 Walgreens 150 tablets FDA listed
Acetaminophen Diphenhydramine HCL 500 mg/1; 25 mg 00363-9664-60 WALGREENS 125 tablets FDA listed
Acetaminophen Diphenhydramine HCL 500 mg/1; 25 mg 00363-9799-75 WALGREEN 75 tablets FDA listed
Pain Reliever PM 500 mg/1; 25 mg 11673-0754-10 TARGET 100 tablets FDA listed
Pain Relief Acetaminophen PM 500 mg/1; 25 mg 11822-0556-01 Rite 80 tablets FDA listed
Pain Relief Acetaminophen PM Extra Strength 500 mg/1; 25 mg 11822-2350-02 Rite 100 tablets FDA listed
Acetaminophen Pm 500 mg/1; 25 mg 17714-0133-50 Advance 50 tablets FDA listed
Pain Relief PM 500 mg/1; 25 mg 21130-0095-01 Safeway 24 tablets FDA listed
Acetaminophen and Diphenhydramine hydrochloride 500 mg/1; 25 mg 21130-0224-18 Better 80 tablets FDA listed
Acetaminophen Diphenhydramine HCl 500 mg/1; 25 mg 21130-0354-02 BETTER 20 tablets FDA listed
Acetaminophen and Diphenhydramine HCL 500 mg/1; 25 mg 21130-0661-10 SAFEWAY 100 tablets FDA listed
Acetaminophen and Diphenhydramine hydrochloride 500 mg/1; 25 mg 30142-0193-14 KROGER 50 tablets FDA listed
Extra Strength Acetaminophen PM 500 mg/1; 25 mg 30142-0755-01 KROGER 100 tablets FDA listed
Pain Relief PM Extra Strength 500 mg/1; 25 mg 36800-0095-03 TopCo 100 tablets FDA listed
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 36800-0466-10 TOP 100 tablets FDA listed
Pain Relief PM 500 mg/1; 25 mg 36800-0556-09 Topco 20 tablets FDA listed
Vicks ZzzQuil Night Pain 25 mg/1; 500 mg 37000-0974-60 The 60 tablets FDA listed
Pain Relief PM Extra Strength 500 mg/1; 25 mg 37808-0556-09 H 20 tablets FDA listed
Pain Relief PM Extra Strength 500 mg/1; 25 mg 37808-0795-03 HEB 100 tablets FDA listed
Acetaminophen and Diphenhydramine Hydrochloride 500 mg/1; 25 mg 37835-0537-01 Bi-Mart 100 tablets FDA listed
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 41163-0228-50 United 50 tablets FDA listed
acetaminophen pm extra strength 500 mg/1; 25 mg 41163-0515-01 United 24 tablets FDA listed
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 41163-0956-09 United 20 tablets FDA listed
pain relief PM 500 mg/1; 25 mg 41250-0195-02 Meijer 50 tablets FDA listed
Acetaminophen and Diphenhydramine HCL 25 mg/1; 500 mg 41415-0661-05 PUBLIX 50 tablets FDA listed
CareOne Acetaminophen PM 500 mg/1; 25 mg 41520-0514-47 American 150 tablets Discontinued
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 41520-0956-09 FOODHOLD 20 tablets FDA listed
Pain Relief PM 500 mg/1; 25 mg 42507-0095-03 HYVEE 100 tablets FDA listed
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 49035-0363-10 EQUATE 100 tablets FDA listed
Extra strength Acetaminophen PM 25 mg/1; 500 mg 49483-0430-40 TIME 400 tablets FDA listed
Tylenol PM 500 mg/1; 25 mg 50269-0552-01 JC 2 tablets FDA listed
Tylenol PM 500 mg/1; 25 mg 50269-0608-06 JC 25 tablets FDA listed
Tylenol PM Extra Strength 500 mg/1; 25 mg 50580-0608-01 Kenvue 24 tablets FDA listed
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 50594-0863-10 Big 100 tablets Discontinued
Pain Relief PM Extra Strength 500 mg/1; 25 mg 50804-0825-02 GoodSense 20 tablets FDA listed
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 50844-0235-15 L.N.K. 50 tablets FDA listed
Pain Reliever PM 500 mg/1; 25 mg 50844-0256-08 L.N.K. 24 tablets FDA listed
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 50844-0556-10 L.N.K. 40 tablets FDA listed
Pain Reliever PM 500 mg/1; 25 mg 51316-0863-50 CVS 500 tablets FDA listed
CAREALL Non-Aspirin PM Extra Strength 500 mg/1; 25 mg 51824-0069-50 New 50 tablets FDA listed
CAREALL Pain Relief PM Extra Strength 500 mg/1; 25 mg 51824-0107-50 New 50 tablets FDA listed
CAREALL Pain Relief PM Extra Strength 500 mg/1; 25 mg 51824-0108-50 New 50 tablets FDA listed
Tylenol PM Extra Strength 500 mg/1; 25 mg 53209-1002-02 Morning 2 tablets FDA listed
Pain Reliever PM 500 mg/1; 25 mg 54257-0278-02 Magno-Humphries, 100 tablets FDA listed
CounterAct PM 25 mg/1; 500 mg 54473-0304-01 Melaleuca, 50 tablets FDA listed
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 55301-0235-06 ARMY 200 tablets Discontinued
Pain Reliever PM 500 mg/1; 25 mg 55319-0562-10 Family 100 tablets FDA listed
dg health pain relief pm extra strength 500 mg/1; 25 mg 55910-0437-71 Dolgencorp 50 tablets FDA listed
Pain Relief PM Extra Strength 500 mg/1; 25 mg 55910-0655-10 DOLGENCORP, 40 tablets FDA listed
Pain Relief PM 500 mg/1; 25 mg 55910-0834-01 DOLGENCORP, 100 tablets FDA listed
pain relief pm extra strength 500 mg/1; 25 mg 56062-0437-71 Publix 50 tablets FDA listed
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 57243-0235-15 Salado 50 tablets FDA listed
Acetaminophen PM 500 mg/1; 25 mg 57344-0095-01 AAA 24 tablets FDA listed
Extra Strength Night Time Pain Medicine 500 mg/1; 25 mg 57896-0224-01 Geri-Care 100 tablets FDA listed
Kroger EXTRA STRENGTH Acetaminophen PM Caplet 500 mg/1; 25 mg 59450-0174-01 The 100 tablets FDA listed
Pain Reliever PM extra strength 500 mg/1; 25 mg 59726-0868-10 P 100 tablets FDA listed
Pain Relief PM 500 mg/1; 25 mg 61504-0095-03 AMERIFOODS 100 tablets FDA listed
Extra Strength Pain Reliever PM 500 mg/1; 25 mg 62936-0224-01 INGLES 50 tablets FDA listed
good sense pain relief pm extra strength 500 mg/1; 25 mg 63629-5880-01 Bryant 14 tablets FDA listed
Pain Relief PM Extra Strength 500 mg/1; 25 mg 63868-0119-50 QUALITY 50 tablets FDA listed
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 63868-0210-20 CHAIN 20 tablets FDA listed
Extra Strength Pain Relief PM 500 mg/1; 25 mg 63941-0095-02 VALU 50 tablets FDA listed
Acetaminophen PM 500 mg/1; 25 mg 63981-0056-54 COSTCO 375 tablets FDA listed
Pain Reliever PM, Extra Strength, 24-7 Life by 7-Eleven 25 mg/1; 500 mg 66715-5640-04 Lil' 24 tablets FDA listed
Tylenol PM Extra Strength, CVP HEALTH 25 mg/1; 500 mg 66715-6417-02 Lil' 2 tablets FDA listed
Tylenol PM Extra Strength, CVP HEALTH 500 mg/1; 25 mg 66715-6517-02 Lil' 2 tablets FDA listed
Pain Reliever PM, Extra Strength, 24-7 Life by 7-Eleven 25 mg/1; 500 mg 66715-8158-03 Lil' 6 tablets FDA listed
Lil Drug Store Tylenol PM Extra Strength 25 mg/1; 500 mg 66715-9817-02 Lil' 2 tablets FDA listed
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 67091-0137-50 WinCo 50 tablets FDA listed
Tylenol PM Extra Strength 500 mg/1; 25 mg 67414-0608-00 Jones 2 tablets FDA listed
Tylenol PM Extra Strength 500 mg/1; 25 mg 67751-0241-01 Navajo 2 tablets FDA listed
Acetaminophen Diphenhydramine HCl 500 mg/1; 25 mg 68016-0654-05 Chain 50 tablets FDA listed
acetaminophen pm extra strength 500 mg/1; 25 mg 68196-0556-54 Sam's 375 tablets FDA listed
Extra Strength Acetaminophen PM 500 mg/1; 25 mg 68391-0430-50 BJWC 500 tablets FDA listed
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 68391-0863-05 BJWC 500 tablets FDA listed
Pain Relief PM Extra Strength 500 mg/1; 25 mg 68998-0071-03 MARC 80 tablets FDA listed
Pain Relief PM Extra Strength 500 mg/1; 25 mg 68998-0195-02 MARC 50 tablets FDA listed
Pain Relief PM Extra Strength 500 mg/1; 25 mg 69168-0003-50 Allegiant 50 tablets FDA listed
Pain Relief PM Extra Strength 500 mg/1; 25 mg 69168-0393-02 Allegiant 150 tablets FDA listed
Pain Reliever PM 500 mg/1; 25 mg 69607-8630-01 WR 24 tablets FDA listed
Genexa Acetaminophen PM Extra Strength 500 mg/1; 25 mg 69676-0063-02 Genexa 100 tablets FDA listed
Cystex PM 500 mg/1; 25 mg 69693-0417-10 Clarion 10 tablets FDA listed
Acetaminophen, Diphenhydramine Hcl 25 mg/1; 500 mg 69842-0572-08 CVS 24 tablets FDA listed
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 69842-0956-09 CVS 20 tablets Discontinued
Acetaminophen Diphenhydramine HCl 25 mg/1; 500 mg 69848-0014-02 Granules 20 tablets FDA listed
Tylenol Pm Extra Strength 500 mg/1; 25 mg 70264-0028-01 R 2 tablets FDA listed
RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief 500 mg/1; 25 mg 70692-0149-03 Strive 30 tablets FDA listed
RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM Caplet 500 mg/1; 25 mg 70692-0471-31 Strive 300 tablets FDA listed
GOOD REMEDIES Extra Strength Pain Relief PM Caplet 500 mg/1; 25 mg 70692-0741-03 Strive 30 tablets FDA listed
pain relief PM 500 mg/1; 25 mg 72036-0095-02 HARRIS 50 tablets FDA listed
Acetaminophen PM 500 mg/1; 25 mg 72036-0171-02 Harris 40 tablets FDA listed
Pain Relief PM 25 mg/1; 500 mg 72090-0006-25 Pioneer 375 tablets FDA listed
Pain Relief PM 25 mg/1; 500 mg 72090-0032-01 Pioneer 375 tablets FDA listed
basic care acetaminophen pm 500 mg/1; 25 mg 72288-0437-78 Amazon.com 100 tablets FDA listed
Acetaminophen Pm 500 mg/1; 25 mg 72476-0171-01 RETAIL 20 tablets FDA listed
Acetaminophen Pm 500 mg/1; 25 mg 73057-0352-03 Ulai 24 tablets FDA listed
Tylenol PM 500 mg/1; 25 mg 73097-0013-02 Savings 2 tablets FDA listed
Pain Relief PM 500 mg/1; 25 mg 76168-0119-25 Velocity 50 tablets FDA listed
meijer EXTRA STRENGTH Pain Relief PM Caplet 500 mg/1; 25 mg 79481-0149-01 Meijer, 100 tablets FDA listed
meijer EXTRA STRENGTH Pain Relief PM CAPLET 500 mg/1; 25 mg 79481-0174-01 Meijer, 100 tablets FDA listed
Pain Reliever PM 500 mg/1; 25 mg 79903-0050-09 WALMART 20 tablets FDA listed
Extra Strength Pain Reliever Pm 500 mg/1; 25 mg 79903-0053-10 WALMART 100 tablets FDA listed
Acetaminophen and Diphenhydramine hydrochloride 500 mg/1; 25 mg 79903-0267-80 WALMART 80 tablets FDA listed
Pain Reliever PM 500 mg/1; 25 mg 79903-0298-10 Walmart 100 tablets FDA listed
Pain Reliever PM 500 mg/1; 25 mg 79903-0307-10 WALMART 100 tablets FDA listed
Acetaminophen PM 500 mg/1; 25 mg 81522-0095-03 FSA 100 tablets FDA listed
NOTTS - Pain Relief PM 500 mg/1; 25 mg 82706-0009-01 VIVUNT 24 tablets FDA listed
ValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra Strength 500 mg/1; 25 mg 82725-1024-01 Cabinet 375 tablets FDA listed
Goodmeds Extra Strength Pain Relief PM 500 mg/1; 25 mg 82725-4124-01 Cabinet 375 tablets FDA listed
Pain Relief PM 25 mg/1; 500 mg 84324-0005-01 NUVICARE 100 tablets FDA listed
Dr Simi Pain Reliever PM 500 mg/1; 25 mg 85786-0101-90 Farmacias 100 tablets FDA listed
Dr. Simi Pain Reliever PM 25 mg/1; 500 mg 85786-0108-24 Farmacias 24 tablets FDA listed
Acetaminophen PM 500 mg/1; 25 mg 85828-0095-03 Grocery 100 tablets FDA listed
Acetaminophen and Diphenhydramine hydrochloride 500 mg/1; 25 mg 58602-0760-14 Aurohealth 50 tablets FDA listed
Tylenol PM Extra Strength 500 mg/1; 25 mg 85237-2945-01 Select 2 tablets FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Apr 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Pain Relief PM Extra Strength (this brand).

Top reported reactions

Completed Suicide161
Toxicity To Various Agents129
Death36
Cardio-respiratory Arrest28
Fatigue26
Pain26
Intentional Product Misuse25

Age at onset

Child1
Adolescent2
Adult91
Elderly8

Reporter sex

404 reports
Male · 40%
Female · 60%

Serious outcomes

Death304
Hospitalization165
Life-threatening8
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 52 8
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
83324-0085-01 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (83324-085-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC $0.0444 / ea $4.44 2024-04-29 Active
83324-0085-50 1 BOTTLE, PLASTIC in 1 CARTON (83324-085-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2024-04-29 Active

Pack size FAQ

What quantity is in NDC 83324-0085-01?
NDC 83324-0085-01 is a 100-count package — 1 bottle, plastic in 1 carton / 100 tablet, coated in 1 bottle, plastic.
What is the difference between NDC 83324-0085-01 and NDC 83324-0085-50?
Both are Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride 500 mg; 25 mg Tablet, Coated — the drug itself is identical. NDC 83324-0085-01 is the 100-count package, while NDC 83324-0085-50 is the 50 tablets package.
What NDC number is used to bill for this package of Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride 500 mg; 25 mg Tablet, Coated?
Bill NDC 83324-0085-01 — the 11-digit billing format is 83324008501. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 14 words

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

⏱️ Dosage and Administration 43 words

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets at bedtime do not take more than 2 caplets of this product in 24 hours children under 12 years do not use

⚠️ Warnings ~1 min read

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin in children under 12 years of age if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks.

Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 16 words

Other information store between 20-25°C (68-77°F) in a dry place retain carton for complete product information

🧪 Active Ingredient 18 words

Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid

🧪 Inactive Ingredients 29 words

Inactive ingredients colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

🎯 Purpose 18 words

Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.