Home › NDC Lookup › Ingredients › Diphenhydramine Hcl › 55319-0802-02
Nighttime Sleep Aid Diphenhydramine HCl 50 mg/30mL Solution, 355 mL — NDC 55319-0802-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nighttime Sleep Aid Diphenhydramine HCl 50 mg/30mL Solution, 355 mL — NDC 55319-802-02 (Billing 55319-0802-02)

by Family Dollar Services Inc · 355 mL in 1 BOTTLE, PLASTIC

This is a package of 355 mL of Nighttime Sleep Aid Diphenhydramine HCl 50 mg/30mL Solution from Family Dollar Services Inc, marketed since Apr 2024 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 55319-0802-02
🏷️ FDA NDC (as labeled) 55319-802-02 billing pads the product segment with a zero
This package
Contains355 mL Pack sizes2 compare ↓
Main listing for product 55319-802 · Also comes in: 177 ml 55319-802-45
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

NDC database record

One package, one record: these facts belong to NDC 55319-802-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55319 labeler · 802 product · 02 package
Package marketed since
Apr 5, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0032251923777
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55319-802-02
Product NDC 55319-802
11-digit billing NDC 55319080202
RxCUI 1248354
UNII TC2D6JAD40
UPC 0032251923777
Application # M010
SPL Set ID 2d63400b-43ae-4dd2-b917-3f65e02366b4
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-04-05
Route ORAL
Dosage form SOLUTION
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1248354
Why two NDCs? The FDA registers this code as 55319-802-02 — 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 → 55319-0802-02. 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.

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
  • Oral products temporarily relieve hay fever and other upper respiratory allergy symptoms like runny nose, sneezing and itchy, watery eyes. They also ease runny nose and sneezing fr...
  • Oral forms are generally taken every 4 to 6 hours, with no more than 6 doses in 24 hours. The amount depends on age and the product, so check the package chart or ask me or your do...
  • It can. Drowsiness is common, so be careful driving or using machinery. Alcohol, sedatives and tranquilizers make it worse, so avoid them.
  • Oral products are not for children under 2 years, and some are not for children under 6. Children can become excitable, and overdose can be very dangerous. Always follow the age di...
📖 Read our full Diphenhydramine guide →

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.

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: 177 ml
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
55319-0802-02 You're viewing this Main listing 355 mL in 1 BOTTLE, PLASTIC 2024-04-05 — Active
55319-0802-45 55319-802-45 177 mL in 1 BOTTLE, PLASTIC 2024-04-05 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 355 mL — 355 ml in 1 bottle, plastic.
How does this package differ from NDC 55319-0802-45?
Both are Nighttime Sleep Aid Diphenhydramine HCl 50 mg/30mL Solution — the drug itself is identical. This page's package is the 355 mL one, while NDC 55319-0802-45 is the 177 ml package.
What NDC number is used to bill for this package of Nighttime Sleep Aid Diphenhydramine HCl 50 mg/30mL Solution?
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
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/30mLthis 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/30mL 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

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

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

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

What it looks like

Color purple
FlavorBerry
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII XY6UN3QB6S
    A sweetener made from corn starch that contains fructose and glucose. It sweetens the medicine to improve taste and may help preserve the product.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

13 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesanhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sucrose, xanthan gum

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerFamily Dollar Services Inc
FDA applicationM010 (OTC MONOGRAPH DRUG)
Labeler code55319
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio54 products on file

More NDCs from Family Dollar Services Inc labeler code 55319

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 📄 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 17 words ▾

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

⏱️ Dosage and Administration 51 words ▾

Directions do not take more than directed mL = milliliter only use the dose cup provided take only one dose per day (24 hours) adults and children 12 years and over: take 30 mL at bedtime if needed or as directed by a doctor children under 12 years: do not use

⚠️ Warnings 127 words ▾

Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product avoid alcoholic beverages. 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

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

📦 Storage and Handling 24 words ▾

Other information each 30 mL contains: sodium 11 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

🧪 Active Ingredient 10 words ▾

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

🧪 Inactive Ingredients 32 words ▾

Inactive ingredients anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sucrose, xanthan gum

🎯 Purpose 3 words ▾

Purpose Nighttime sleep-aid

📄 Do Not Use 21 words ▾

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

📄 Ask a Doctor Before Use If 28 words ▾

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

📄 Ask a Doctor or Pharmacist Before Use If 14 words ▾

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

📄 When Using This Product 7 words ▾

When using this product avoid alcoholic beverages.

📄 Stop Use and Ask a Doctor If 25 words ▾

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.

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 21 words ▾

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

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-426-9391

📄 Package Label / Principal Display Panel 61 words ▾

Principal Display Panel FAMILY Wellness™ * COMPARE TO THE ACTIVE INGREDIENT IN VICKS® ZzzQuil® NIGHTTIME SLEEP-AID NIGHTTIME SLEEP AID Diphenhydramine HCl 50 mg per 30 mL Nighttime Sleep-Aid • Non-habit forming • Not for colds or for pain 12 FL OZ (355 mL) AGES 12 YEARS & OVER BERRY FLAVORED F-002A REV A NDC 55319-802-45 Family wellness 44-002A Family wellness 44-002A

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

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.

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) ✓ 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 Family Dollar Services Inc. 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 177 ml (55319-0802-45). 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?
Family Dollar Services Inc 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.
← 55319-0792-03 · Family 55319-0804-01 · Family →
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.