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Nighttime Sleep-Aid Diphenhydramine HCl 50 mg Capsule, Liquid Filled, 60-count — NDC 46122-0775-64 package photo

Nighttime Sleep-Aid Diphenhydramine HCl 50 mg Capsule, Liquid Filled, 60-count

by AMERISOURCE BERGEN · 1 BOTTLE in 1 CARTON (46122-775-64) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE
NDC 46122-0775-64
🏷️ FDA NDC (as labeled) 46122-775-64 billing pads the product segment with a zero
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 46122-775-64
Product NDC 46122-775
11-digit billing NDC 46122077564
NCPDP billing unit EA — each (per item)
RxCUI 1020477
UNII TC2D6JAD40
Application # M010
SPL Set ID 16b2edd2-c16b-5713-e063-6394a90acf46
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 2024-04-11
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DIPHENHYDRAMINE HYDROCHLORIDE
GPI-14 60300020100110
GCN Seq No 003703
GCN 27482
HICL code 004480
Ingredient (HICL) Diphenhydramine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2E
Therapeutic class — specific (HIC3) Sedative-Hypnotics,Non-Barbiturate
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name GNP NIGHTTIME SLEEP AID 50 MG
FDB brand name Nighttime Sleep Aid
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 46122-775-64 — 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 → 46122-0775-64. 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

LabelerAMERISOURCE BERGEN
FDA applicationM010 (OTC MONOGRAPH DRUG)
Labeler code46122
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio206 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

Label name GNP NIGHTTIME SLEEP AID 50 MG Ingredient Diphenhydramine Hcl
📖 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 →

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.

💊 What it looks like

Color blue
ShapeOval
ImprintB50
Size13 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

  • 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 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII NL4J9F21N9
    Polyethylene glycol 600 is a synthetic liquid polymer used as a solvent and humectant in medicines. It helps dissolve active ingredients and keeps products from drying out.
  • 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 6O92ICV9RU
    A waxy substance derived from sorbitol that helps mix oil and water together in medicines. It's used as an emulsifier to keep ingredients evenly blended and stable.
  • 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 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.

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

The official label also statesFD&C blue #1, gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution

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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.117 $7.03 / 60 capsules
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.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.120 $0.095
▲ Up 13% over the last 9 months.
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
Diphenhydramine Hydrochloride 50 mg 42806-0649-10 Epic 1000 capsules $0.020 — FDA listed save 83%
Diphenhydramine Hydrochloride 50 mg 00904-2056-61 Major 100 capsules $0.031 — Availability likely save 73%
Banophen 50 mg 00904-5307-60 Major 100 capsules $0.031 — Discontinued save 73%
Dimetane 50 mg 57237-0368-01 Rising 100 capsules $0.031 — Availability likely save 73%
Diphenhydramine HCl 50 mg 82568-0005-01 AARNA 100 capsules $0.031 — Availability likely save 73%
Nighttime Sleep Aid Maximum Strength 50 mg 62011-0416-01 Strategic 32 capsules $0.095 — Discontinued save 19%
Nighttime Sleep Aid maximum strength 50 mg 70000-0527-01 Cardinal 32 capsules $0.104 — Availability likely save 11%
Nighttime Sleep-Aid 50 mgthis 46122-0775-64 AMERISOURCE 60 capsules $0.117 — Availability likely —
Nighttime Sleep Aid 50 mg 70000-0616-01 Cardinal 100 capsules $0.117 — Availability likely —
Sleep Aid 50 mg 70677-1151-01 Strategic 32 capsules $0.117 — Availability likely —
Sleep Aid 50 mg 83324-0151-32 QUALITY 32 capsules $0.117 — Availability likely —
Nighttime Sleep-Aid 50 mg 46122-0695-72 AMERISOURCE 60 capsules $0.117 — Discontinued —
Wal Som Nighttime Sleep Aid 50 mg 00363-0816-16 Walgreens 160 capsules — — FDA listed —
Wal Som Nighttime Sleep Aid Nighttime 50 mg 00363-0860-16 Walgreens 160 capsules — — FDA listed —
Allergy Relief 50 mg 00363-6123-20 WALGREEN 100 capsules — — FDA listed —
Sleep Aid 50 mg 11673-0360-32 TARGET 32 capsules — — FDA listed —
Pharbedryl 50 mg 16103-0347-08 Pharbest 100 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 17714-0021-01 Advance 100 capsules — — FDA listed —
Sleep Aid 50 mg 21130-0052-32 Better 32 capsules — — FDA listed —
Sleep Aid 50 mg 21130-0816-32 Safeway, 32 capsules — — FDA listed —
Sleep Aid 50 mg 21130-0860-32 Safeway, 32 capsules — — FDA listed —
SleepAid (Diphenhydramine HCL) 50 mg 24689-0154-01 APNAR 100 capsules — — FDA listed —
Kroger Nighttime Sleep-Aid 50 mg 30142-0558-64 THE 64 capsules — — FDA listed —
Nighttime Sleep-Aid 50 mg 30142-0681-18 KROGER 64 capsules — — FDA listed —
Sleep Aid 50 mg 30142-0715-32 The 32 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 35916-0438-01 SOFTGEL 100 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 35916-0470-01 Softgel 1000 capsules — — FDA listed —
Diphenhydramine hydrochloride 50 mg 35916-0472-01 Softgel 1000 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 36800-0116-32 TOP 32 capsules — — FDA listed —
Sleep Aid Maximum Strength 50 mg 37808-0860-12 H 120 capsules — — FDA listed —
Sleep Aid Nighttime 50 mg 41163-0860-32 United 32 capsules — — FDA listed —
Unisom SleepGels Nighttime Sleep-Aid 50 mg 41167-0061-00 Chattem, 8 capsules — — Discontinued —
Nighttime Sleep-Aid 50 mg 42681-0051-01 Whole 32 capsules — — FDA listed —
Nighttime sleep aid 50 mg 42829-0950-20 ASCENT 120 capsules — — Discontinued —
Sleep Aid 50 mg 49035-0736-10 EQUATE 100 capsules — — FDA listed —
Benadryl Allergy Extra Strength Liqui-Gels 50 mg 50580-0322-20 Kenvue 10 capsules — — FDA listed —
Sleep Aid 50 mg 50804-0410-38 Good 32 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 50804-0860-32 Good 32 capsules — — FDA listed —
Nighttime SLEEP AID 50 mg 51013-0817-01 PuraCap 100 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 53345-0005-01 Humanwell 12000 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 53345-0022-01 Humanwell 12000 capsules — — FDA listed —
Nighttime Sleep-Aid 50 mg 53943-0485-18 DISCOUNT 64 capsules — — FDA listed —
Discount Drugmart Nighttime Sleep-Aid 50 mg 53943-0822-64 Discount 64 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 54738-0116-01 Richmond 100 capsules — — FDA listed —
Diphenhydramine HCl 50 mg 55154-0661-00 Cardinal 10 capsules — — FDA listed —
Sleep Aid 50 mg 55319-0564-32 Family 32 capsules — — FDA listed —
Sleep Aid 50 mg 55910-0798-16 Dolgencorp, 16 capsules — — FDA listed —
Sleep Aid 50 mg 55910-0894-16 Dolgencorp, 16 capsules — — FDA listed —
Sleep Aid Nighttime 50 mg 55910-0916-16 Dolgencorp, 16 capsules — — FDA listed —
Sleep Aid Maximum Strength 50 mg 59726-0760-64 P 64 capsules — — FDA listed —
Sleep Aid Maximum Strength 50 mg 59726-0816-64 P 64 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 59726-0916-32 P 32 capsules — — FDA listed —
Diphenhydramine HCL 50 mg 63187-0866-10 Proficient 10 capsules — — FDA listed —
Banophen 50 mg 63629-9451-01 Bryant 30 capsules — — FDA listed —
Sleep Aid Maximum Strength 50 mg 63868-0415-32 QUALITY 32 capsules — — FDA listed —
Sleep Aid Maximum Strength 50 mg 63868-0900-32 QUALITY 32 capsules — — FDA listed —
Nighttime Sleep-Aid 50 mg 63941-0604-17 VALU 60 capsules — — FDA listed —
Nighttime Sleep-Aid 50 mg 63941-0683-17 VALU 60 capsules — — FDA listed —
Nighttime sleep aid Maximum Strength 50 mg 63941-0860-16 Best 1 capsule — — FDA listed —
Nighttime sleep aid Maximum Strength 50 mg 63941-0916-16 Best 1 capsule — — FDA listed —
Diphenhydramine HCL 50 mg 66267-0081-30 NuCare 30 capsules — — FDA listed —
Diphenhydramine HCL 50 mg 66267-0779-06 NuCare 6 capsules — — FDA listed —
Diphenhydramine HCL 50 mg 66424-0021-01 SDA 100 capsules — — FDA listed —
Sleep Aid Maximum Strength 50 mg 67091-0413-32 WinCo 32 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 68210-4160-08 Prodose, 8 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 68210-5057-01 Prodose, 3000 capsules — — FDA listed —
Banophen 50 mg 68788-7830-01 Preferred 15 capsules — — FDA listed —
Diphenhydramine HCL 50 mg 68788-9688-01 Preferred 15 capsules — — FDA listed —
Sleep Aid 50 mg 69168-0410-03 Allegiant 250 capsules — — FDA listed —
Sleep Aid 50 mg 69168-0917-40 Allegiant 32 capsules — — FDA listed —
Sleep Aid Maximum Strength 50 mg 69256-0860-32 Harris 32 capsules — — FDA listed —
Nighttime Sleep Aid Maximum Strength 50 mg 69256-0916-32 Harris 32 capsules — — FDA listed —
nighttime sleep-aid 50 mg 69452-0322-79 Bionpharma 160 capsules — — FDA listed —
Nighttime Sleep-Aid 50 mg 69452-0427-10 BIONPHARMA 32 capsules — — FDA listed —
Nighttime Sleep-Aid 50 mg 69452-0451-22 BIONPHARMA 120 capsules — — FDA listed —
Allergy Relief 50 mg 69452-0452-20 BIONPHARMA 100 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 69607-0916-06 WR 96 capsules — — FDA listed —
Sleep Aid Nighttime 50 mg 69842-0860-32 CVS 32 capsules — — FDA listed —
Sleep Aid Nighttime 50 mg 69842-0916-32 CVS 32 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 70692-0785-61 Strive 16 capsules — — FDA listed —
RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid Softgel 50 mg 70692-0834-71 Strive 275 capsules — — FDA listed —
Banophen 50 mg 71335-0081-00 Bryant 12 capsules — — FDA listed —
Diphenhydramine HCl 50 mg 71399-1028-01 Akron 100 capsules — — FDA listed —
SleepAid Softgels 50 mg 72090-0023-01 PIONEER 180 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 72476-0860-32 Care 32 capsules — — FDA listed —
Nighttime Sleep Aid Maximum Strength 50 mg 72476-0916-32 Care 32 capsules — — FDA listed —
Diphenhydramine HCL 50 mg 72789-0532-20 PD-Rx 20 capsules — — FDA listed —
Pharbedryl 50 mg 73057-0347-08 Ulai 100 capsules — — FDA listed —
Allergy Relief Diphenhydramine HCL 50 MG 73581-0020-10 YYBA 1000 capsules — — FDA listed —
DIPHENHYDRAMINE HYDROCHLORIDE 50mg 50 mg 73629-0001-22 AMZ789 220 capsules — — FDA listed —
TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid 50 mg 76162-0438-96 Topco 96 capsules — — FDA listed —
Nightime Sleep Aid 50 mg 76168-0065-37 Velocity 1 capsule — — FDA listed —
Antihistamine 50 mg 77333-0231-10 Gendose 100 capsules — — FDA listed —
Sleep Aid 50 mg 81522-0916-32 FSA 32 capsules — — FDA listed —
Sleep Aid 50 mg 82442-0530-32 TARGET 32 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 83059-0028-08 Shield 8 capsules — — Discontinued —
Nighttime Sleep Aid 50 mg 83059-0109-08 Shield 8 capsules — — Discontinued —
SleepAid Softgels 50 mg 84324-0011-01 NUVICARE 100 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 85828-0410-38 Grocery 32 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
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.

📊 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 Nighttime Sleep-Aid (this brand).

Top reported reactions

Fatigue4,086
Headache3,587
Pain3,581
Infusion Related Reaction3,252
Nausea3,244
Arthralgia3,151
Pneumonia2,700

Age at onset

Neonate56
Infant19
Child170
Adolescent258
Adult4,329
Elderly1,413

Reporter sex

31,676 reports
Male · 33%
Female · 67%
Unknown · 0%

Serious outcomes

Hospitalization10,720
Death6,735
Life-threatening1,770
Disabling1,002
Reports over time (by year) — tap or hover for the count & year
2025 2026 2,669 1,289
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
46122-0775-64 You're viewing this 1 BOTTLE in 1 CARTON (46122-775-64) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE 2024-04-11 Active

📄 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 19 words ▾

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

⏱️ Dosage and Administration 34 words ▾

Directions ■ Adults and children 12 years of age and over: One softgel (50 mg) at bedtime if needed, or as directed by a doctor. ■ swallow whole; do not crush, chew, or dissolve

⚠️ Warnings 24 words ▾

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

📦 Storage and Handling 25 words ▾

Other information ■ store at 20°C to 25°C (68°F to 77°F) ■ avoid high humidity and excessive heat above 40°C (104°F). ■ protect from light

🧪 Active Ingredient 9 words ▾

Active ingredient (in each capsule) Diphenhydramine HCl 50 mg

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution

🎯 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 ↗
← 46122-0774-51 · Amerisource 46122-0776-37 · Amerisourcebergen →
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.