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Vicks PainQuil and Vicks PainQuil PM PAIN RELIEVER Acetaminophen, Diphenhydramine HCl Kit — NDC 69423-0849-36 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Vicks PainQuil and Vicks PainQuil PM PAIN RELIEVER Acetaminophen, Diphenhydramine HCl Kit — NDC 69423-849-36 (Billing 69423-0849-36)

by The Procter & Gamble Manufacturing Company · 1 KIT in 1 PACKAGE * 354 mL in 1 BOTTLE * 354 mL in 1 BOTTLE * 354 mL in 1 BOTTLE * 354 mL in 1 BOTTLE * 354 mL in 1 BOTTLE

This is a package of Vicks PainQuil and Vicks PainQuil PM PAIN RELIEVER Acetaminophen, Diphenhydramine HCl Kit from The Procter & Gamble Manufacturing Company, marketed since May 2024 and currently FDA-listed.

NDC 69423-0849-36
🏷️ FDA NDC (as labeled) 69423-849-36 billing pads the product segment with a zero
This package
Contains1 kit in 1 package * 354 mL in 1 bottle * 354 mL in 1 bottle * 354 mL in 1 bottle * 354 mL in 1 bottle * 354 mL in 1 bottle Pack sizes2 compare ↓
Product page 69423-0849-24 Also comes in: 1 kit 69423-849-24
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 69423-849-36 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69423 labeler · 849 product · 36 package
Package marketed since
Mar 17, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6942384936 9
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69423-849-36
Product NDC 69423-849
11-digit billing NDC 69423084936
Application # M013
SPL Set ID 163a1617-b7f1-4c80-e063-6394a90a74c3
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-05-07
Route ORAL
Dosage form KIT
Why two NDCs? The FDA registers this code as 69423-849-36 — 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 → 69423-0849-36. 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.

Clinical

📖 About the active ingredient: Acetaminophen, Diphenhydramine HCl MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
🧪 What is this product?

This is an oral OTC kit containing pain reliever tablets with acetaminophen and diphenhydramine hydrochloride. Acetaminophen is typically used to reduce pain and fever, while diphenhydramine is a first-generation antihistamine commonly included in pain products to promote drowsiness, particularly in formulations marketed for nighttime use. The kit format allows consumers to choose between daytime and nighttime pain relief options. This product is marketed under FDA's OTC monograph rules for pain relievers and sleep aids.

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: 1 kit
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
69423-0849-24 69423-849-24 Main listing 1 KIT in 1 PACKAGE * 354 mL in 1 BOTTLE * 354 mL in 1 BOTTLE * 354 mL in 1 BOTTLE * 354 mL in 1 BOTTLE * 354 mL in 1 BOTTLE 2024-05-07 — Active
69423-0849-36 You're viewing this 1 KIT in 1 PACKAGE * 354 mL in 1 BOTTLE * 354 mL in 1 BOTTLE * 354 mL in 1 BOTTLE * 354 mL in 1 BOTTLE * 354 mL in 1 BOTTLE 2025-03-17 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 kit in 1 package * 354 ml in 1 bottle * 354 ml in 1 bottle * 354 ml in 1 bottle * 354 ml in 1 bottle * 354 ml in 1 bottle.
What NDC number is used to bill for this package of Vicks PainQuil and Vicks PainQuil PM PAIN RELIEVER Acetaminophen, Diphenhydramine HCl Kit?
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
Vicks PainQuil and Vicks PainQuil PM PAIN RELIEVER 84126-0351-24 The 1 kit — — FDA listed —
Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid 41226-0672-02 Kroger 1 kit — — FDA listed —
Vicks PainQuil and Vicks PainQuil PM PAIN RELIEVERthis 69423-0849-36 The 1 kit — — FDA listed —
Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid 00363-8757-02 WALGREENS 1 kit — — FDA listed —
Vicks PainQuil and Vicks PainQuil PM LIQUICAPS PAIN RELIEVER 84126-0377-20 The 100 capsules — — 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
May 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 red / purple
FlavorCherry
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.

From the label’s inactive-ingredient sectionalcohol, anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water, xanthan gum alcohol, anhydrous citric acid, FD&C Red No. 40, flavor, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water, xanthan gum

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

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 Procter & Gamble Manufacturing Company
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code69423
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio851 products on file

More NDCs from The Procter & Gamble Manufacturing Company labeler code 69423

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 🆘 Overdosage 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 32 words ▾

Uses for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.

Uses for the temporary relief of minor aches and pains associated with: sore throat headache muscular aches backache

⏱️ Dosage and Administration 81 words ▾

Directions take only one dose (30 mL) per day (24 hours) only use the dose cup provided only use as directed adults & children 12 yrs & over 30 mL at bedtime children under 12 yrs do not use

Directions take only as directed do not exceed 3 doses (30 mL each) per day (24 hours) only use the dose cup provided adults & children 12 yrs & over 30 mL every 6 hours children under 12 yrs do not use

⚠️ Warnings 220 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 3 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product 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 Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 3 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product 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 Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

🆘 Overdosage 74 words ▾

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

In case of overdose, get medical help or contact a Poison Control Center right away. 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 34 words ▾

Other information each 30 mL contains: sodium 89 mg do not exceed 25°C and do not refrigerate.

Other information each 30 mL contains: sodium 93 mg do not exceed 25°C and do not refrigerate.

🧪 Active Ingredient 30 words ▾

Active ingredients (in each 30 mL) Acetaminophen 1000 mg Diphenhydramine HCl 50 mg Purpose Pain reliever Nighttime sleep-aid

Active ingredients (in each 30 mL) Acetaminophen 1000 mg Purpose Pain reliever

🧪 Inactive Ingredients 60 words ▾

Inactive ingredients alcohol, anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water, xanthan gum

Inactive ingredients alcohol, anhydrous citric acid, FD&C Red No. 40, flavor, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water, xanthan gum

🎯 Purpose 8 words ▾

Purpose Pain reliever Nighttime sleep-aid

Purpose Pain reliever

📄 Do Not Use 45 words ▾

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. for children under 12 years of age with any other product containing diphenhydramine, even one used on skin

📄 Ask a Doctor Before Use If 46 words ▾

Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland a sodium-restricted diet

Ask a doctor before use if you have liver disease a sodium-restricted diet

📄 Ask a Doctor or Pharmacist Before Use If 63 words ▾

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers

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.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

📄 When Using This Product 19 words ▾

When using this product avoid alcoholic beverages drowsiness will occur do not drive a motor vehicle or operate machinery

📄 Stop Use and Ask a Doctor If 100 words ▾

Stop use and ask a doctor if 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 sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. These could be signs of a serious condition.

Stop use and ask a doctor if 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 20 words ▾

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 12 words ▾

Keep out of reach of children.

Keep out of reach of children.

📄 Questions or Comments 4 words ▾

Questions? 1-877-881-5813

Questions? 1-877-881-5813

📄 Package Label / Principal Display Panel 107 words ▾

PRINCIPAL DISPLAY PANEL - Convenience Pack Vicks ® PainQuil™ PAIN RELIEVER / Vicks ® PainQuil™ PM PAIN RELIEVER + NIGHTTIME SLEEP-AID MAX STRENGTH‡ VALUE PACK ‡Maximum strength dose of active ingredients per dosing interval, only use as directed. Vicks ® PainQuil™ PAIN RELIEVER STARTS WORKING FAST FOR RELIEF OF: ACHES PAINS HEADACHE SORE THROAT BLACK CHERRY FLAVORED Alcohol 10% Vicks ® PainQuil™ PM PAIN RELIEVER + NIGHTTIME SLEEP-AID STARTS WORKING FAST FOR RELIEF OF: ACHES PAINS HEADACHE SORE THROAT + OCCASSIONAL SLEEPLESSNESS MIDNIGHT CHERRY FLAVORED Alcohol 10% 2 BOTTLES - 1 PAINQUIL/1 PAINQUIL PM 12 FL OZ (354 mL) EACH; TOTAL 24 FL OZ (708 mL) 849

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

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 Acetaminophen, Diphenhydramine HCl — the ingredient across all brands.

Top reported reactions

Fatigue85
Nausea65
Headache59
Pain59
Dyspnoea54
Diarrhoea51
Dizziness41

Reporter sex

0 reports

Serious outcomes

Death50
Life-threatening21
Disabling16
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 69 0
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.

About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) ✓ 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 Procter & Gamble Manufacturing Company. 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 1 kit (69423-0849-24). 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 Procter & Gamble Manufacturing Company 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.
← 69423-0848-01 · The 69423-0850-52 · The →
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.