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(from DailyMed)

Nighttime Sleep Aid Diphenhydramine Hydrochloride 50 mg Capsule, Liquid Filled, 8-count

by Shield Pharmaceuticals Corp · 1 BLISTER PACK in 1 CARTON (83059-0109-8) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
NDC 83059-0109-08
🏷️ FDA NDC (as labeled) 83059-0109-8 billing pads the package segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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 →
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 83059-0109-8
Product NDC 83059-0109
11-digit billing NDC 83059010908
RxCUI 1020477
UNII TC2D6JAD40
Application # M010
SPL Set ID 60d62a23-d5e4-425c-8604-af8aabfb6ad4
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 Discontinued
FDA listing status Discontinued by firm (certified through Aug 2026)
Marketing start 2025-11-11
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 83059-0109-8 — 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 → 83059-0109-08. 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

LabelerShield Pharmaceuticals Corp
FDA applicationM010 (OTC MONOGRAPH DRUG)
Labeler code83059
First marketedNov 2025
Product typeHuman Otc Drug
Portfolio103 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...
📖 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
Diphenhydramine Hydrochloride 50 mg 00904-2056-61 Major 100 capsules $0.031 Availability likely
Banophen 50 mg 00904-5307-60 Major 100 capsules $0.031 Discontinued
Dimetane 50 mg 57237-0368-01 Rising 100 capsules $0.031 Availability likely
Diphenhydramine HCl 50 mg 82568-0005-01 AARNA 100 capsules $0.031 Availability likely
Nighttime Sleep Aid Maximum Strength 50 mg 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
Nighttime Sleep-Aid 50 mg 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
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 mgthis 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
Sleep Aid Nighttime 50 mg 36800-0784-96 TOPCO 96 capsules FDA listed
Nighttime Sleep Aid 50 mg 83059-0073-08 Shield 8 capsules FDA listed
HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL 50 mg 42507-0834-32 HyVee 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

🏛️
2025
On the market since
Nov 2025
📍
2026
Currently FDA-listed
1 year 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
83059-0109-08 You're viewing this 1 BLISTER PACK in 1 CARTON (83059-0109-8) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2025-11-11 Discontinued by firm

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 83059-0109-8, 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: 83059-0109-08, written without dashes as 83059010908. 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 83059-0109-08, the first segment (83059) is the labeler code FDA assigned to Shield Pharmaceuticals Corp; the middle segment (0109) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Shield Pharmaceuticals Corp 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 7 words

Uses • for relief of occasional sleeplessness

⏱️ Dosage and Administration 25 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 1 words

Warnings

🧪 Active Ingredient 9 words

Active ingredient (in each softgel) Diphenhydramine HCl 50 mg

🧪 Inactive Ingredients 17 words

Inactive ingredients FD&C Blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

🎯 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.