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Kroger EXTRA STRENGTH Acetaminophen PM Caplet Acetaminophen, Diphenhydramine hydrochloride 500 mg; 25 mg Tablet, 100-count — NDC 59450-0174-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Kroger EXTRA STRENGTH Acetaminophen PM Caplet Acetaminophen, Diphenhydramine hydrochloride 500 mg; 25 mg Tablet, 100-count — NDC 59450-174-01 (Billing 59450-0174-01)

by The Kroger Co. · 1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Kroger EXTRA STRENGTH Acetaminophen PM Caplet Acetaminophen, Diphenhydramine hydrochloride 500 mg; 25 mg Tablet from The Kroger Co., marketed since Dec 2024 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 59450-0174-01
🏷️ FDA NDC (as labeled) 59450-174-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes3 compare ↓
Main listing for product 59450-174 · Also comes in: 50 tablets 59450-174-05 200 tablets 59450-174-20
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59450-174-01
Product NDC 59450-174
11-digit billing NDC 59450017401
RxCUI 1092189
UNII 362O9ITL9D, TC2D6JAD40
UPC 0041260013133
Application # M012
SPL Set ID 24a75ffa-c2a7-71a9-e063-6394a90a0e25
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 2024-12-17
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1092189
Why two NDCs? The FDA registers this code as 59450-174-01 — 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 → 59450-0174-01. 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.

Clinical

🧪 What is this product?

This is an over-the-counter tablet that combines two active ingredients commonly used together for nighttime symptom relief. Acetaminophen is typically used to reduce fever and relieve minor aches and pains. Diphenhydramine hydrochloride is an antihistamine that is commonly used to promote drowsiness and help with sleep. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rulebook for this category of over-the-counter pain reliever and sleep aid combination products.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Acetaminophen, Diphenhydramine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen, Diphenhydramine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

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: 50 tablets 200 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
59450-0174-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE 2024-12-17 — Active
59450-0174-05 59450-174-05 1 BOTTLE in 1 CARTON / 50 TABLET in 1 BOTTLE 2024-12-17 — Active
59450-0174-20 59450-174-20 2 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE 2024-12-17 — Active

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 1 bottle in 1 carton / 100 tablet in 1 bottle.
How does this package differ from NDC 59450-0174-05?
Both are Kroger EXTRA STRENGTH Acetaminophen PM Caplet Acetaminophen, Diphenhydramine hydrochloride 500 mg; 25 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 59450-0174-05 is the 50 tablets package.
What NDC number is used to bill for this package of Kroger EXTRA STRENGTH Acetaminophen PM Caplet Acetaminophen, Diphenhydramine hydrochloride 500 mg; 25 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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 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 — — Discontinued —
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 mgthis 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 —
Extra Strength Acetaminophen PM 500 mg/1; 25 mg 41226-0043-20 Kroger 200 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
Dec 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.

What it looks like

Color blue
ShapeOval
ImprintS525
Size18 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.

Manufacturer & labeler

LabelerThe Kroger Co.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code59450
First marketedDec 2024
Product typeHuman Otc Drug
Portfolio96 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.

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 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

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

⏱️ Dosage and Administration 44 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 and 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 a serious underlying medical illness • pain gets worse or lasts more than 10 days • fever gets worse or lats 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 (1-800-222-1222) right away.

📦 Storage and Handling 17 words ▾

Other information • store at room temperature between 20º-25ºC (68º-77ºF) • protect from light, heat and moisture

🧪 Active Ingredient 12 words ▾

Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients FD&C blue no. 1, FD&C blue no. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyvinylpyrrolidone K30, pregelatinized starch, stearic acid powder, titanium dioxide

🎯 Purpose 6 words ▾

Purpose Pain reliever Nighttime sleep aid

📄 Keep Out of Reach of Children 24 words ▾

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Questions or Comments 5 words ▾

Questions or comments? Call 1-800-632-6900

📄 Package Label / Principal Display Panel 3 words ▾

Packaging Kroger-174 Kroger-174

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 ✓ Available
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 The Kroger Co.. 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 2 other package presentations of this same product, including 50 tablets (59450-0174-05), 200 tablets (59450-0174-20). 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?
The Kroger Co. 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.
← 59450-0048-48 · The 59450-0210-01 · Kroger →
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.