Nighttime Sleep Aid Berry Flavor DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL Liquid, 177 mL
by WINCO FOODS, LLC · 177 mL in 1 BOTTLE, PLASTIC (67091-630-06)
NDC 67091-0630-06
🏷️ FDA NDC (as labeled)
67091-630-06
billing pads the product segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Aug 20, 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)
67091-630-06
Product NDC
67091-630
11-digit billing NDC
67091063006
RxCUI
1248354
UNII
TC2D6JAD40
Application #
M010
SPL Set ID
6fb6cfde-30a6-419c-973d-8abdc72611ed
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
2023-01-09
Route
ORAL
Dosage form
LIQUID
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 67091-630-06 — 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 → 67091-0630-06. 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
LabelerWINCO FOODS, LLC
FDA applicationM010 (OTC MONOGRAPH DRUG)
Labeler code67091
First marketedJan 2023
Product typeHuman Otc Drug
Portfolio137 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...
Patient education
Supplement & herbal interactions
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.
💬 Questions about DIPHENHYDRAMINE HYDROCHLORIDE?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 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 EE90ONI6FF
Potassium citrate is a salt derived from citric acid and potassium. In medicines, it acts as a buffer to adjust and maintain the pH balance of the product, helping keep it stable and palatable.
-
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 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
-
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 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.
10 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesanhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, 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.
💲 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 system | Per mL | Per 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.
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sleep Aid 50 mg/30mL 46122-0754-29 | Amerisource | 355 ml | $0.008 | — | 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/30mLthis 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 | — |
| Up and Up Nighttime Sleep Aid 50 mg/30mL 11673-0186-40 | Target | 355 ml | — | — | FDA listed | — |
| Nighttime Sleep Aid 50 mg/30mL 41226-0793-02 | Kroger | 2 bottles | — | — | 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
🏛️
2023
On the market since
Jan 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Nighttime Sleep Aid Berry Flavor (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 29%
Female · 71%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 67091-0630-06 You're viewing this | 177 mL in 1 BOTTLE, PLASTIC (67091-630-06) | 2023-01-09 | Active |
🧭 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 FDA registers it as 67091-630-06, 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: 67091-0630-06, written without dashes as 67091063006. 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 67091-0630-06, the first segment (67091) is the labeler code FDA assigned to WINCO FOODS, LLC; the middle segment (0630) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) 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 WINCO FOODS, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
WINCO FOODS, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses ▪ for the relief of occasional sleeplessness ▪ reduces time to fall asleep if you have difficulty falling asleep
⏱️ Dosage and Administration ▾
Directions ▪ take only one dose per day (24 hours) ▪ only use cup provided. adults & children 12yrs & over 30 mL at bed time if needed or as directed by a doctor Children under 12 yrs do not use
⚠️ Warnings ▾
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 two 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.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
📦 Storage and Handling ▾
Other information ▪ each 30 mL dose contains: potassium 5 mg, sodium 10 mg ▪ store at room temperature
🧪 Active Ingredient ▾
Active ingredient (in each 30 mL dose cup) Diphenhydramine HCl 50 mg
🧪 Inactive Ingredients ▾
Inactive ingredients anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.
🎯 Purpose ▾
Purpose Nighttime sleep-aid
No label section mentions that — try another word, or open the full label on DailyMed below.
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.