HomeNDC LookupIngredientsDiphenhydramine Hcl › 62011-0416-01
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Nighttime Sleep Aid Maximum Strength Diphenhydramine HCL 50 mg Capsule, 32-count

by Strategic Sourcing Services LLC · 1 BOTTLE, PLASTIC in 1 BOX (62011-0416-1) / 32 CAPSULE in 1 BOTTLE, PLASTIC
NDC 62011-0416-01
🏷️ FDA NDC (as labeled) 62011-0416-1 billing pads the package 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 →

🆔 Identity & classification

FDA NDC (as labeled) 62011-0416-1
Product NDC 62011-0416
11-digit billing NDC 62011041601
RxCUI 1020477
UNII TC2D6JAD40
UPC 0052569142837
Application # M012
SPL Set ID de2579f8-3838-476d-b587-f2f746286186
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 2019-09-30
Route ORAL
Dosage form CAPSULE
Substance DIPHENHYDRAMINE HYDROCHLORIDE
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 HM 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 62011-0416-1 — a 5-4-1 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 package segment → 62011-0416-01. 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

LabelerStrategic Sourcing Services LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code62011
First marketedSep 2019
Product typeHuman Otc Drug
Portfolio315 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 HM NIGHTTIME SLEEP AID 50 MG Ingredient Diphenhydramine Hcl
📗 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.

💡 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 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII N6K5787QVP
    Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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.

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

The official label also statesFD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol sorbitan, white ink

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 DailyMedingredient 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 $0.095 $3.05 / 32 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
Sep 2021 May 2022 Dec 2023 Feb 2026 $0.106 $0.080
▼ Down 3% over the last 13 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 79%
Diphenhydramine Hydrochloride 50 mg 00904-2056-61 Major 100 capsules $0.031 Availability likely save 67%
Banophen 50 mg 00904-5307-60 Major 100 capsules $0.031 Discontinued save 67%
Dimetane 50 mg 57237-0368-01 Rising 100 capsules $0.031 Availability likely save 67%
Diphenhydramine HCl 50 mg 82568-0005-01 AARNA 100 capsules $0.031 Availability likely save 67%
Nighttime Sleep Aid Maximum Strength 50 mgthis 62011-0416-01 Strategic 32 capsules $0.095 FDA listed
Nighttime Sleep Aid maximum strength 50 mg 70000-0527-01 Cardinal 32 capsules $0.104 Availability likely +10%
Nighttime Sleep-Aid 50 mg 46122-0775-64 AMERISOURCE 60 capsules $0.117 Availability likely +23%
Nighttime Sleep Aid 50 mg 70000-0616-01 Cardinal 100 capsules $0.117 Availability likely +23%
Sleep Aid 50 mg 70677-1151-01 Strategic 32 capsules $0.117 Availability likely +23%
Sleep Aid 50 mg 83324-0151-32 QUALITY 32 capsules $0.117 Availability likely +23%
Nighttime Sleep-Aid 50 mg 46122-0695-72 AMERISOURCE 60 capsules $0.117 Discontinued +23%
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

🏛️
2019
On the market since
Sep 2019
📍
2026
Currently FDA-listed
7 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
62011-0416-01 You're viewing this 1 BOTTLE, PLASTIC in 1 BOX (62011-0416-1) / 32 CAPSULE in 1 BOTTLE, PLASTIC 2019-09-30 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 6 words

Use for relief of occasional sleeplessness.

⏱️ Dosage and Administration 24 words

Directions adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

⚠️ 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 trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product avoid alcoholic drinks. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks.

Insomnia may be a symptom of a 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 (1-800-222-1222) right away.

📦 Storage and Handling 6 words

Other information store between 15-30°C (59-86°F)

🧪 Active Ingredient 9 words

Active ingredient (in each softgel) Diphenhydramine HCL 50 mg

🧪 Inactive Ingredients 20 words

Inactive ingredients FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol sorbitan, white ink

🎯 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.