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HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL Diphenhydramine hydrochloride 50 mg Capsule, Liquid Filled, 64-count — NDC 42507-0834-64 package photo

HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL Diphenhydramine hydrochloride 50 mg Capsule, Liquid Filled, 64-count

by HyVee Inc · 1 BOTTLE in 1 CARTON (42507-834-64) / 64 CAPSULE, LIQUID FILLED in 1 BOTTLE
NDC 42507-0834-64
🏷️ FDA NDC (as labeled) 42507-834-64 billing pads the product segment with a zero
This package
Contains64-count Pack sizes3 compare ↓
Also comes in: 32 capsules 42507-0834-32 96 capsules 42507-0834-96
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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) 42507-834-64
Product NDC 42507-834
11-digit billing NDC 42507083464
RxCUI 1020477
UNII TC2D6JAD40
UPC 0075450856828
Application # M010
SPL Set ID 496ce4ba-08a9-ee99-e063-6294a90ac9a7
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 2026-08-20
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 42507-834-64 — 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 → 42507-0834-64. 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

LabelerHyVee Inc
FDA applicationM010 (OTC MONOGRAPH DRUG)
Labeler code42507
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio136 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

📗 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
Imprint903
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 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

The official label also statesFD&C blue no.1, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol sorbitan solution, titanium dioxide

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 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.
Try another pack size: 32 capsules 96 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.

🔁 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 —
Diphenhydramine Hydrochloride 50 mg 17714-0021-01 Advance 100 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 54738-0116-01 Richmond 100 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 68210-5057-01 Prodose, 3000 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 83059-0109-08 Shield 8 capsules — — Discontinued —
Diphenhydramine Hydrochloride 50 mg 53345-0005-01 Humanwell 12000 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 68210-4160-08 Prodose, 8 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 35916-0470-01 Softgel 1000 capsules — — FDA listed —
Nighttime sleep aid Maximum Strength 50 mg 63941-0860-16 Best 1 capsule — — FDA listed —
SleepAid Softgels 50 mg 72090-0023-01 PIONEER 180 capsules — — FDA listed —
Nighttime sleep aid Maximum Strength 50 mg 63941-0916-16 Best 1 capsule — — FDA listed —
RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid Softgel 50 mg 70692-0834-71 Strive 275 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 83059-0028-08 Shield 8 capsules — — Discontinued —
Sleep Aid Nighttime 50 mg 36800-0784-96 TOPCO 96 capsules — — FDA listed —
TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid 50 mg 76162-0438-96 Topco 96 capsules — — FDA listed —
SleepAid Softgels 50 mg 84324-0011-01 NUVICARE 100 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 35916-0438-01 SOFTGEL 100 capsules — — FDA listed —
Diphenhydramine hydrochloride 50 mg 35916-0472-01 Softgel 1000 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 53345-0022-01 Humanwell 12000 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 70692-0785-61 Strive 16 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 83059-0073-08 Shield 8 capsules — — FDA listed —
HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL 50 mgthis 42507-0834-64 HyVee 64 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

🔬 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 Diphenhydramine hydrochloride — the ingredient across all brands.

Top reported reactions

Fatigue16,399
Nausea14,606
Headache14,003
Pain11,969
Dyspnoea11,085
Pruritus10,525
Infusion Related Reaction9,947

Age at onset

Neonate106
Infant195
Child1,828
Adolescent1,476
Adult20,867
Elderly9,044

Reporter sex

171,992 reports
Male · 33%
Female · 66%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 13,771 5,313
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
42507-0834-32 1 BOTTLE in 1 CARTON (42507-834-32) / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE 2026-08-20 Active
42507-0834-64 You're viewing this 1 BOTTLE in 1 CARTON (42507-834-64) / 64 CAPSULE, LIQUID FILLED in 1 BOTTLE 2026-08-20 Active
42507-0834-96 96 CAPSULE, LIQUID FILLED in 1 BOTTLE (42507-834-96) 2026-08-20 Active

Pack size FAQ

What quantity is in NDC 42507-0834-64?
NDC 42507-0834-64 is a 64-count package — 1 bottle in 1 carton / 64 capsule, liquid filled in 1 bottle.
What is the difference between NDC 42507-0834-64 and NDC 42507-0834-32?
Both are HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL Diphenhydramine hydrochloride 50 mg Capsule, Liquid Filled — the drug itself is identical. NDC 42507-0834-64 is the 64-count package, while NDC 42507-0834-32 is the 32 capsules package.
What NDC number is used to bill for this package of HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL Diphenhydramine hydrochloride 50 mg Capsule, Liquid Filled?
Bill NDC 42507-0834-64 — the 11-digit billing format is 42507083464. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 42507-834-64, 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: 42507-0834-64, written without dashes as 42507083464. 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 42507-0834-64, the first segment (42507) is the labeler code FDA assigned to HyVee Inc; the middle segment (0834) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (64) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by HyVee Inc. 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 2 other package presentations of this same product, including 32 capsules (42507-0834-32), 96 capsules (42507-0834-96). 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?
HyVee Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 7 words ▾

​Uses • for relief of occasional sleeplessness

⏱️ Dosage and Administration 26 words ▾

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

⚠️ Warnings 133 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 serious underlying medical illness. ​ ​If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 20 words ▾

​Other information • store at 20-25°C (68-77° F) • keep bottle tightly closed • protect from light, heat and moisture

🧪 Active Ingredient 9 words ▾

​Active ingredient (in each softgel) Diphenhydramine HCl 50 mg

🧪 Inactive Ingredients 16 words ▾

​Inactive ingredients FD&C blue no.1, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol sorbitan solution, 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 ↗
← 42507-0820-43 · Hy-Vee, 42507-0835-05 · HyVee →
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.