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Sleep Aid Nighttime Diphenhydramine HCL 50 mg Capsule, 96-count — NDC 41163-0860-96 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sleep Aid Nighttime Diphenhydramine HCL 50 mg Capsule, 96-count — NDC 41163-860-96 (Billing 41163-0860-96)

by United Natural Foods, Inc. dba UNFI · 96 CAPSULE in 1 BOTTLE, PLASTIC

This is a package of 96 capsules of Sleep Aid Nighttime Diphenhydramine HCL 50 mg Capsule from United Natural Foods, Inc. dba UNFI, marketed since Dec 2019 and currently FDA-listed.

NDC 41163-0860-96
🏷️ FDA NDC (as labeled) 41163-860-96 billing pads the product segment with a zero
This package
Contains96-count Pack sizes2 compare ↓
Product page 41163-0860-32 Also comes in: 32 capsules 41163-860-32
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 41163-860-96
Product NDC 41163-860
11-digit billing NDC 41163086096
RxCUI 1020477
UNII TC2D6JAD40
UPC 0041163488304
Application # M010
SPL Set ID 217a211e-b8bf-4119-a094-0e5e733d0b18
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 2019-12-27
Route ORAL
Dosage form CAPSULE
Substance DIPHENHYDRAMINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

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 EQL SLEEP AID 50 MG SOFTGEL
FDB brand name Sleep Aid
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 003703
  • GCN: 27482
  • HICL (First Databank): 004480
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 1020477
Why two NDCs? The FDA registers this code as 41163-860-96 — 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 → 41163-0860-96. 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

Label name EQL SLEEP AID 50 MG SOFTGEL 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
  • 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 eachPer 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: 32 capsules
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
41163-0860-32 41163-860-32 Main listing 1 BOTTLE, PLASTIC in 1 BOX / 32 CAPSULE in 1 BOTTLE, PLASTIC 2019-12-27 — Active
41163-0860-96 You're viewing this 96 CAPSULE in 1 BOTTLE, PLASTIC 2019-12-27 — Active

Pack size FAQ

What quantity is in this package?
This is a 96-count package — 96 capsule in 1 bottle, plastic.
How does this package differ from NDC 41163-0860-32?
Both are Sleep Aid Nighttime Diphenhydramine HCL 50 mg Capsule — the drug itself is identical. This page's package is the 96-count one, while NDC 41163-0860-32 is the 32 capsules package.
What NDC number is used to bill for this package of Sleep Aid Nighttime Diphenhydramine HCL 50 mg Capsule?
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
Diphenhydramine Hydrochloride 50 mg 42806-0649-10 Epic 1000 capsules $0.020 — FDA listed —
Diphenhydramine Hydrochloride 50 mg 00904-2056-61 Major 100 capsules $0.030 — Availability likely —
Banophen 50 mg 00904-5307-60 Major 100 capsules $0.030 — Discontinued —
Dimetane 50 mg 57237-0368-01 Rising 100 capsules $0.030 — Availability likely —
Diphenhydramine HCl 50 mg 82568-0005-01 AARNA 100 capsules $0.030 — Availability likely —
Nighttime Sleep Aid Maximum Strength 50 mg 62011-0416-01 Strategic 32 capsules $0.095 — Discontinued —
Nighttime Sleep Aid maximum strength 50 mg 70000-0527-01 Cardinal 32 capsules $0.104 — FDA listed —
Nighttime Sleep-Aid 50 mg 46122-0775-64 AMERISOURCE 60 capsules $0.111 — Availability likely —
Nighttime Sleep Aid 50 mg 70000-0616-01 Cardinal 100 capsules $0.111 — Availability likely —
Sleep Aid 50 mg 70677-1151-01 Strategic 32 capsules $0.111 — Availability likely —
Sleep Aid 50 mg 83324-0151-32 QUALITY 32 capsules $0.111 — Availability likely —
Nighttime Sleep-Aid 50 mg 46122-0695-72 AMERISOURCE 60 capsules $0.111 — 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 mgthis 41163-0860-96 United 96 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
Dec 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.

What it looks like

Color blue
ShapeCapsule
ImprintP50
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 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.

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

The official label also statesFD&C blue #1, gelatin, glycerin, 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 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

LabelerUnited Natural Foods, Inc. dba UNFI
FDA applicationM010 (OTC MONOGRAPH DRUG)
Labeler code41163
First marketedDec 2019
Product typeHuman Otc Drug
Portfolio211 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.

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 🧪 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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 6 words ▾

Uses For relief of occasional sleeplessness.

⏱️ Dosage and Administration 24 words ▾

Directions adults and children 12 years of age and older: 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.

🧪 Active Ingredient 9 words ▾

Active ingredient (in each softgel) Diphenhydramine HCl 50 mg

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol, sorbitan, white ink

🎯 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 26 words ▾

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 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 drinks

📄 Stop Use and Ask a Doctor If 26 words ▾

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 10 words ▾

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

📄 Keep Out of Reach of Children 22 words ▾

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.

📄 Other Information 6 words ▾

Other information store between 15-30ºC (59-86ºF)

📄 Questions or Comments 7 words ▾

Questions or comments? Call toll free 1-855-423-2630

📄 Package Label / Principal Display Panel 82 words ▾

Principal Display Panel Compare to Unisom® SleepGels® active ingredient** maximum strength Sleep-Aid softgels diphenhydramine HCl, 50 mg (nighttime Sleep-Aid) Fall asleep fast sleep soundly and wake up refreshed liquid filled softgels one softgel per dose **This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Unisom® SleepGels®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA

Product Label EQUALINE Nighttime Sleep-Aid Diphenhydramine HCl 50 mg

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.

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 Sleep Aid Nighttime (this brand).

Top reported reactions

Fatigue4,007
Pain3,567
Headache3,546
Infusion Related Reaction3,250
Nausea3,217
Arthralgia3,145
Pneumonia2,660

Age at onset

Neonate41
Infant17
Child163
Adolescent247
Adult3,374
Elderly1,356

Reporter sex

29,797 reports
Male · 33%
Female · 67%
Unknown · 0%

Serious outcomes

Hospitalization10,395
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 3,957 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 United Natural Foods, Inc. dba UNFI. 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 32 capsules (41163-0860-32). 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?
United Natural Foods, Inc. dba UNFI 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.
← 41163-0855-12 · United 41163-0862-25 · United →
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.