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

by TopCo Associates LLC · 1 BOTTLE, PLASTIC in 1 CARTON (36800-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
NDC 36800-0095-03
🏷️ FDA NDC (as labeled) 36800-095-03 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Also comes in: 225 tablets 36800-0095-17
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 36800-095-03
Product NDC 36800-095
11-digit billing NDC 36800009503
RxCUI 1092189
UNII 362O9ITL9D, TC2D6JAD40
Application # M013
SPL Set ID 3b672ec7-8658-4b43-a79d-094ac8bc6904
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 2012-11-30
Route ORAL
Dosage form TABLET, COATED
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 36800-095-03 — 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 → 36800-0095-03. 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

LabelerTopCo Associates LLC
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code36800
First marketedNov 2012
Product typeHuman Otc Drug
Portfolio408 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

🧪 What is this product?

This is an over-the-counter coated tablet taken by mouth that contains acetaminophen and diphenhydramine hydrochloride. Acetaminophen is typically used to relieve minor aches, pains, and fever. Diphenhydramine hydrochloride is an antihistamine commonly used to promote drowsiness and sleep. This combination product is designed for nighttime pain relief in people who also want sleep support. It is marketed as an OTC monograph drug, meaning it follows established FDA rules for this product category.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 225 tablets
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 mg 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 —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 63868-0325-50 Chain 50 tablets $0.046 — FDA listed —
Pain Relief PM 500 mg/1; 25 mg 70677-0081-01 Strategic 100 tablets $0.046 — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 62011-0256-01 Strategic 50 tablets $0.047 — FDA listed —
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 mgthis 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

🏛️
2012
On the market since
Nov 2012
📍
2026
Currently FDA-listed
14 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 Marketing startStatus
36800-0095-03 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (36800-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2012-11-30 Active
36800-0095-17 225 TABLET, COATED in 1 BOTTLE, PLASTIC (36800-095-17) 2019-03-21 Active

Pack size FAQ

What quantity is in NDC 36800-0095-03?
NDC 36800-0095-03 is a 100-count package — 1 bottle, plastic in 1 carton / 100 tablet, coated in 1 bottle, plastic.
What is the difference between NDC 36800-0095-03 and NDC 36800-0095-17?
Both are Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride 500 mg; 25 mg Tablet, Coated — the drug itself is identical. NDC 36800-0095-03 is the 100-count package, while NDC 36800-0095-17 is the 225 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 36800-0095-03 — the 11-digit billing format is 36800009503. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 36800-095-03, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 36800-0095-03, written without dashes as 36800009503. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 36800-0095-03, the first segment (36800) is the labeler code FDA assigned to TopCo Associates LLC; the middle segment (0095) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by TopCo Associates LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 225 tablets (36800-0095-17). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
TopCo Associates LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 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 ↗
← 36800-0093-09 · TOPCO 36800-0097-05 · TOPCO →
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.