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Allergy Relief Diphenhydramine HCl 50 mg Tablet, 48-count — NDC 69452-0445-77 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Allergy Relief Diphenhydramine HCl 50 mg Tablet, 48-count — NDC 69452-445-77 (Billing 69452-0445-77)

by BIONPHARMA INC. · 4 BLISTER PACK in 1 CARTON / 12 TABLET in 1 BLISTER PACK

This is a package of 48 tablets of Allergy Relief Diphenhydramine HCl 50 mg Tablet from BIONPHARMA INC., marketed since Aug 2025 and currently FDA-listed.

NDC 69452-0445-77
🏷️ FDA NDC (as labeled) 69452-445-77 billing pads the product segment with a zero
This package
Contains48-count Pack sizes2 compare ↓
Product page 69452-0445-24 Also comes in: 150 tablets 69452-445-24
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

NDC database record

One package, one record: these facts belong to NDC 69452-445-77 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69452 labeler · 445 product · 77 package
Package marketed since
Aug 11, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6945244577 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69452-445-77
Product NDC 69452-445
11-digit billing NDC 69452044577
RxCUI 1085945
UNII TC2D6JAD40
Application # M012
SPL Set ID 3c1953a1-32e9-6c81-e063-6294a90a9fa2
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 2025-08-11
Route ORAL
Dosage form TABLET
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1085945
Why two NDCs? The FDA registers this code as 69452-445-77 — 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 → 69452-0445-77. 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

📖 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: 150 tablets
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
69452-0445-24 69452-445-24 Main listing 1 BOTTLE in 1 CARTON / 150 TABLET in 1 BOTTLE 2025-08-11 — Active
69452-0445-77 You're viewing this 4 BLISTER PACK in 1 CARTON / 12 TABLET in 1 BLISTER PACK 2025-08-11 — Active

Pack size FAQ

What quantity is in this package?
This is a 48-count package — 4 blister pack in 1 carton / 12 tablet in 1 blister pack.
How does this package differ from NDC 69452-0445-24?
Both are Allergy Relief Diphenhydramine HCl 50 mg Tablet — the drug itself is identical. This page's package is the 48-count one, while NDC 69452-0445-24 is the 150 tablets package.
What NDC number is used to bill for this package of Allergy Relief Diphenhydramine HCl 50 mg Tablet?
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
Allergy Relief 50 mg 00363-1799-08 Walgreen 12 tablets — — FDA listed —
Jet-Asleep Double Strength Night Time Sleep Aid 50 mg 15579-0828-17 Bell 100 tablets — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 17714-0023-50 Advance 50 tablets — — FDA listed —
Diphenhydramine HCl Maximum Strength 50 mg 37835-0852-50 Bi-Mart 50 tablets — — FDA listed —
Allergy Relief 50 mg 46122-0829-51 AMERISOURCE 24 tablets — — FDA listed —
Benadryl Allergy EXTRA STRENGTH 50 mg 50580-0533-24 Kenvue 12 tablets — — FDA listed —
Diphenhydramine HCl 50 mg 51316-0221-08 CVS 12 tablets — — FDA listed —
Allergy Relief Extra Strength 50 mg 51316-0799-08 CVS 12 tablets — — FDA listed —
Allergy Relief 50 mg 55910-0450-12 DOLGENCORP 24 tablets — — FDA listed —
Sominex Max 50 mg 63029-0505-16 Medtech 16 tablets — — FDA listed —
Allergy Relief 50 mgthis 69452-0445-77 BIONPHARMA 48 tablets — — FDA listed —
Somnapure Clinical Strength 50 mg 69721-0005-30 Force 30 tablets — — 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
Aug 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.

What it looks like

Color white
ShapeCapsule
ImprintDH50
Size14 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 L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 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 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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 statescroscarmellose sodium, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, 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.

Manufacturer & labeler

LabelerBIONPHARMA INC.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code69452
First marketedAug 2025
Product typeHuman Otc Drug
Portfolio163 products on file

More NDCs from BIONPHARMA INC. labeler code 69452

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 📦 Storage and Handling 🧪 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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 32 words ▾

Uses ■ temporarily relieves these symptoms due to hay fever or the other upper respiratory allergies: ■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat

⏱️ Dosage and Administration 41 words ▾

Directions adults and children 12 years and over ■ take 1 tablet every 4 to 6 hours, or as directed by the doctor ■ do not take more than 6 tablets in 24 hours children under 12 years do not use

⚠️ Warnings 21 words ▾

Warnings ■ May cause excitability especially in children. ■ May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.

📦 Storage and Handling 17 words ▾

Other information ■ each tablet contains: calcium 35 mg ■ store between 20-25°C (68-77°F). Protect from light.

🧪 Active Ingredient 9 words ▾

Active ingredient (in each capsule) Diphenhydramine HCl 50 mg

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients croscarmellose sodium, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

🎯 Purpose 2 words ▾

Purpose Antihistamine

📄 Do Not Use 23 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 31 words ▾

Ask a doctor before use if you have ■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ difficulty in urination due to enlargement of the 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 19 words ▾

When using this product ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery

📄 Stop Use and Ask a Doctor If 15 words ▾

Stop use and ask a doctor if sleeplessness persisits continuously for more than 2 weeks

🤰 If Pregnant or Breast-Feeding 11 words ▾

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

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Centre right away.

📄 Questions or Comments 13 words ▾

Questions or comments? call toll-free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

📄 Package Label / Principal Display Panel 46 words ▾

150''s count †Compare to the active ingredient in Benadryl® Allergy Extra Strength a+ health TM extra strength allergy relief diphenhydramine HCl tablets, 50 mg antihistamine dye free 150 tablets • sneezing • runny nose • itchy, watery eyes • itching of the nose or throat carton

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.

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 BIONPHARMA 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 1 other package presentation of this same product, including 150 tablets (69452-0445-24). 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?
BIONPHARMA 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.
← 69452-0444-31 · BIONPHARMA 69452-0446-23 · Bionpharma →
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.