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VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl 50 mg/30mL Liquid, 354 mL

by The Procter & Gamble Manufacturing Company · 354 mL in 1 BOTTLE, PLASTIC (69423-812-12)
NDC 69423-0812-12
🏷️ FDA NDC (as labeled) 69423-812-12 billing pads the product segment with a zero
This package
Contains354 mL Pack sizes2 compare ↓
Also comes in: 2 bottles 69423-0812-24
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) 69423-812-12
Product NDC 69423-812
11-digit billing NDC 69423081212
RxCUI 1248354
UNII TC2D6JAD40
UPC 0323900038585
Application # M010
SPL Set ID 05f77c69-c8ea-f8ba-e063-6394a90aa60f
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 2015-02-03
Route ORAL
Dosage form LIQUID
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 69423-812-12 — 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 → 69423-0812-12. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Propionic acid derivatives, Antihistamines for topical use, Aminoalkyl ethers
How it works Histamine H1 Receptor Antagonists
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

LabelerThe Procter & Gamble Manufacturing Company
FDA applicationM010 (OTC MONOGRAPH DRUG)
Labeler code69423
First marketedFeb 2015
Product typeHuman Otc Drug
Portfolio849 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 it is MedlinePlus · NLM

Diphenhydramine is used to treat allergy and cold symptoms: sneezing runny nose red, itchy, watery eyes itching of the nose or throat Diphenhydramine is also used to treat insomnia (difficulty falling asleep or staying asleep) in adults, but should not be used to make a child sleepy. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Diphenhydramine is also available in combination with other medications. This monograph only includes information about the use of diphenh...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Diphenhydramine is mainly used to temporarily ease the stuffy, sneezy, itchy symptoms of allergies — like hay fever — and the common cold. Think runny nose, sneezing, watery or itc...
  • What exactly does diphenhydramine treat?
  • Yes, and that's one of the most important things to know about this medicine. Drowsiness is one of its most common effects — it crosses into the brain and that's what causes the se...
  • It depends on your child's age and the product. Most oral diphenhydramine products are not recommended for children under 6, and liquid products labeled for children are generally...
📖 Read our full Diphenhydramine guide →
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 mLPer 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: 2 bottles
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
Sleep Aid 50 mg/30mL 46122-0754-29 Amerisource 355 ml $0.009 — Availability likely —
Good Sense Sleep Time 50 mg/30mL 00113-0186-30 L. 177 ml $0.013 — Discontinued —
LEADER Nighttime Sleep-Aid 50 mg/30mL 70000-0174-02 CARDINAL 177 ml $0.014 — Availability likely —
Nighttime Sleep-Aid 50 mg/30mL 83324-0015-06 Chain 177 ml $0.014 — Availability likely —
Dye Free Wal Sleep Z 50 mg/30mL 00363-0753-12 WALGREEN 354 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 00363-7300-12 WALGREEN 354 ml — — FDA listed —
Sleep Aid 50 mg/30mL 00363-8020-02 Walgreen 355 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 11673-0285-02 TARGET 2 bottles — — FDA listed —
Sleep Aid 50 mg/30mL 11673-0750-12 TARGET 355 ml — — FDA listed —
Rite Aid Nighttime Sleep Aid Non Habit Forming 50 mg/30mL 11822-7530-01 RITE 354 ml — — FDA listed —
Nighttime Sleep-Aid 50 mg/30mL 11822-8002-01 Rite 177 ml — — FDA listed —
EZ Nite Sleep 50 mg/30mL 21130-0014-06 Safeway, 177 ml — — FDA listed —
Nightime Sleep Aid 50 mg/30mL 21130-0711-01 BETTER 354 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 30142-0095-96 Kroger 2 bottles — — FDA listed —
Topcare ZZZ Sleep 50 mg/30mL 36800-0200-30 Topco 177 ml — — Discontinued —
ZzzQuil Nighttime Sleep-Aid 50 mg/30mL 37000-0500-04 The 118 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 37808-0186-30 H 177 ml — — Discontinued —
Nighttime Sleep Aid 50 mg/30mL 37835-0319-30 Bi-Mart 355 ml — — FDA listed —
Diphenhydramine HCl 50 mg/30mL 37835-0519-12 BI-MART 355 ml — — FDA listed —
Equaline Night Time Sleep Aid 50 mg/30mL 41163-0186-30 United 177 ml — — Discontinued —
KROGER Nighttime Sleep-Aid 50 mg/30mL 41226-0730-12 KROGER 354 ml — — FDA listed —
nitetime sleep aid 50 mg/30mL 41250-0044-30 Meijer 177 ml — — Discontinued —
Meijer Nighttime Sleep-aid Berry Flavor 50 mg/30mL 41250-0738-12 MEIJER 354 ml — — FDA listed —
Meijer Nighttime Sleep Aid Non Habit Forming 50 mg/30mL 41250-0853-12 MEIJER 354 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 41520-0034-06 Care 177 ml — — FDA listed —
Night Time Sleep Aid 50 mg/30mL 42507-0959-40 HyVee 355 ml — — FDA listed —
Nighttime Sleep Aid Alcohol Free 50 mg/30mL 49035-0330-02 Wal-Mart 355 ml — — FDA listed —
Sleep Aid 50 mg/30mL 49035-0704-02 Wal-Mart 355 ml — — FDA listed —
Sleep Aid NightTime 50 mg/30mL 49580-0314-02 P 355 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 50844-0200-45 L.N.K. 177 ml — — Discontinued —
Nighttime Sleep Aid 50 mg/30mL 50844-0250-45 L.N.K. 177 ml — — FDA listed —
Nighttime Sleep-Aid 50 mg/30mL 53041-0633-58 Guardian 177 ml — — FDA listed —
Nighttime Sleep-Aid 50 mg/30mL 53942-0522-28 DeMoulas 354 ml — — FDA listed —
Night Time Sleep-Aid 50 mg/30mL 53943-0522-25 Discount 117 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 55319-0802-02 Family 355 ml — — FDA listed —
Night Time Sleep Aid 50 mg/30mL 55910-0114-12 Dolgencorp, 355 ml — — FDA listed —
dg health sleep aid 50 mg/30mL 55910-0186-30 Dolgencorp, 177 ml — — Discontinued —
Sleep Aid NightTime 50 mg/30mL 55910-0899-12 Dolgencorp, 355 ml — — FDA listed —
Sleep Aid NightTime 50 mg/30mL 55910-0981-02 Dolgencorp, 355 ml — — FDA listed —
CVS Health Nighttime Sleep-Aid 50 mg/30mL 59779-0893-06 CVS 177 ml — — FDA listed —
Nighttime Sleep Aid, 24-7 Life BY 7-ELEVEN, 6oz 50 mg/30mL 66715-6543-04 Lil' 177 ml — — FDA listed —
Nighttime Sleep Aid Berry Flavor 50 mg/30mL 67091-0630-06 WINCO 177 ml — — FDA listed —
Premier Value Nighttime Sleep-Aid Liquid Sleep-Aid 50 mg/30mL 68016-0219-12 Chain 354 ml — — FDA listed —
Nighttime Sleep Aid Berry Flavor 50 mg/30mL 68163-0730-06 Raritan 177 ml — — FDA listed —
berkley and jensen sleep aid 50 mg/30mL 68391-0186-40 BJWC 3 bottles — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 68391-0793-09 BJWC 3 bottles — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 69168-0446-39 Allegiant 354 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 69168-0486-39 Allegiant 355 ml — — FDA listed —
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OF 50 mg/30mL 69423-0795-12 The 354 ml — — FDA listed —
VICKS ZzzQuil NIGHTTIME SLEEP-AID 50 mg/30mLthis 69423-0812-12 The 354 ml — — FDA listed —
Vicks ZzzQuil Soothing Sleep Nighttime Sleep-Aid 50 mg/30mL 69423-0830-12 The 354 ml — — FDA listed —
Sleep-Aid 50 mg/30mL 69842-0470-02 CVS 355 ml — — FDA listed —
CVS Health Nighttime Sleep Aid 50 mg/30mL 69842-0753-12 CVS 354 ml — — FDA listed —
basic care nighttime sleep aid 50 mg/30mL 72288-0186-40 Amazon.com 355 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 76162-0200-45 TOPCO 177 ml — — FDA listed —
Nighttime Sleep-Aid Non-Habit Forming 50 mg/30mL 76281-0522-24 AptaPharma 118 ml — — FDA listed —
Goodnow Sleep Aid 50 mg/30mL 82501-0186-00 Gobrands, 355 ml — — FDA listed —
Quality Choice Nighttime Sleep Aid 50 mg/30mL 83324-0336-06 QUALITY 177 ml — — FDA listed —
Vicks ZzzQuil Nighttime Sleep-Aid 84126-0306-03 The 1 kit — — FDA listed —
ZzzQuil Nighttime Sleep-Aid 50 mg/30mL 84126-0316-04 The 118 ml — — FDA listed —
VICKS ZzzQuil FREE and CLEAR NIGHTTIME SLEEP-AID 50 mg/30mL 84126-0370-12 The 354 ml — — FDA listed —
VICKS ZzzQuil FREE and CLEAR NIGHTTIME SLEEP-AID 50 mg/30mL 84126-0371-12 The 354 ml — — FDA listed —
Revasol Sleep Aid 50 mg/30mL 84379-0284-04 Rnv 118 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 85828-0793-01 Grocery 354 ml — — FDA listed —
nighttime sleep aid 50 mg/30mL 72288-0765-40 Amazon.com 355 ml — — 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

🏛️
2015
On the market since
Feb 2015
📍
2026
Currently FDA-listed
11 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Diphenhydramine HCl (matched by generic name) — the program that covers self-administered drugs. 8 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Diphenhydramine HCl. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$374.3K
Claims incl. refills
20.3K
Beneficiaries
11.2K
Spend / beneficiary
$33.36
Spend / claim
$18.44
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Vicks ZzzQuil Nighttime Sleep-Aid (this brand).

Top reported reactions

Fatigue3,979
Pain3,560
Headache3,533
Infusion Related Reaction3,250
Nausea3,199
Arthralgia3,135
Pneumonia2,653

Age at onset

Neonate41
Infant17
Child163
Adolescent247
Adult3,364
Elderly1,344

Reporter sex

29,524 reports
Male · 33%
Female · 67%
Unknown · 0%

Serious outcomes

Hospitalization10,336
Death6,408
Life-threatening1,684
Disabling989
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,941 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69423-0812-12 You're viewing this 354 mL in 1 BOTTLE, PLASTIC (69423-812-12) 2021-10-11 Active
69423-0812-24 2 BOTTLE, PLASTIC in 1 CARTON (69423-812-24) / 354 mL in 1 BOTTLE, PLASTIC 2021-10-11 Active

Pack size FAQ

What quantity is in NDC 69423-0812-12?
NDC 69423-0812-12 contains 354 mL — 354 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl 50 mg/30mL Liquid?
Bill NDC 69423-0812-12 — the 11-digit billing format is 69423081212. 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 69423-812-12, 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: 69423-0812-12, written without dashes as 69423081212. 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 69423-0812-12, the first segment (69423) is the labeler code FDA assigned to The Procter & Gamble Manufacturing Company; the middle segment (0812) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) 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 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 2 bottles (69423-0812-24). 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.

📄 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 18 words ▾

Uses for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

⏱️ Dosage and Administration 43 words ▾

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

⚠️ Warnings 22 words ▾

Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin

🆘 Overdosage 15 words ▾

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

📦 Storage and Handling 17 words ▾

Other information each 30 mL dose cup contains: sodium 22 mg store at no greater than 25°C

🧪 Active Ingredient 12 words ▾

Active ingredient (in each 30 mL dose cup) Diphenhydramine HCl 50 mg

🧪 Inactive Ingredients 28 words ▾

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

🎯 Purpose 3 words ▾

Purpose 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.