Home › NDC Lookup › Ingredients › Diphenhydramine Hcl › 44224-1114-01
Itch Eraser Diphenhydramine HCl .51 g/25.5g Spray, 1 bottle — NDC 44224-1114-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Itch Eraser Diphenhydramine HCl .51 g/25.5g Spray, 1 bottle — NDC 44224-1114-1 (Billing 44224-1114-01)

by Tender Corporation d/b/a Adventure Ready Brands · 1 BOTTLE, SPRAY in 1 BOX / 25.5 g in 1 BOTTLE, SPRAY

This is a package of 1 bottle of Itch Eraser Diphenhydramine HCl .51 g/25.5g Spray from Tender Corporation d/b/a Adventure Ready Brands, marketed since Nov 2024 and currently FDA-listed. It is this product's only package size.

NDC 44224-1114-01
🏷️ FDA NDC (as labeled) 44224-1114-1 billing pads the package segment with a zero
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) 44224-1114-1
Product NDC 44224-1114
11-digit billing NDC 44224111401
RxCUI 1050080, 1724486
UNII TC2D6JAD40
UPC 0044224624109
Application # M017
SPL Set ID 2204e135-6a23-68a2-e063-6394a90ac019
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 2024-11-11
Route TOPICAL
Dosage form SPRAY
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1050080
Why two NDCs? The FDA registers this code as 44224-1114-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 44224-1114-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Propionic acid derivatives, Antihistamines for topical use, Aminoalkyl ethers
How it works Histamine H1 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
44224-1114-01 You're viewing this Main listing 1 BOTTLE, SPRAY in 1 BOX / 25.5 g in 1 BOTTLE, SPRAY 2024-11-11 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Xpect Extra Strength Itch Relief 2 mg/100mL 42961-0218-01 Cintas 59.1 ml — — FDA listed —
Itch Eraser .51 g/25.5gthis 44224-1114-01 Tender 1 bottle — — FDA listed —
Itch Relief 20.3 g/L 61010-8300-01 Safetec 0591 l — — FDA listed —
Itch Relief 20 mg/mL 79903-0217-25 Wal-Mart 74 ml — — FDA listed —
Itch Relief 20 mg/mL 81522-0751-25 FSA 74 ml — — 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

🏛️
2024
On the market since
Nov 2024
📍
2026
Currently FDA-listed
2 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.

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.

  • 0.128 g / 25.5 g UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • 18.48 g / 25.5 g UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 0.77 g / 25.5 g 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.
  • 0.51 g / 25.5 g UNII Z6J799EAJK
    Oat is a cereal grain used in medicines as a filler and binder. It helps give the medication its shape and structure while adding bulk to the formulation.
  • 0.77 g / 25.5 g UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • 0.128 g / 25.5 g UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • 0.128 g / 25.5 g UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • 4.05 g / 25.5 g 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.
  • 0.026 g / 25.5 g UNII FM5526K07A
    Zinc acetate is a salt compound containing zinc. It acts as a buffer and pH stabilizer in formulations, helping maintain the medicine's chemical stability and shelf life.

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

The official label also statesglycerinm oat beta glucanm povidone, purified water, sd alcohol 40-2, sodium bicarbonate (baking soda), tea tree oil, vitamine e acetate, zinc acetate

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

LabelerTender Corporation d/b/a Adventure Ready Brands
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code44224
First marketedNov 2024
Product typeHuman Otc Drug
Portfolio10 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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 words ▾

Uses For the temporary relief of pain and itching associated with, minor burns, sunburn,minor cuts, insects bites, minor skin irritations, rashes due to poison ivy, poison oak, and poison sumac

⏱️ Dosage and Administration 40 words ▾

Directions Shake before use remove safety tab from spray head adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. children under 2 years of age: consult a doctor

⚠️ Warnings 87 words ▾

Warnings For external use only Do not use on large areas of the body, with any other product containing diphenhydramine, even one taken by mouth Ask a doctor before use on chicken ox, measles when using this product avoid contact with eyes. Stop use and ask a doctor if condition worses, if symptoms persist for more than 7 days or clear up and occur again within a few days. Keep out of reach of children if swallowed, get medical help or contact poison control center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredient Diphenhydramine HCl 2%

🧪 Inactive Ingredients 24 words ▾

Inactive Ingredients glycerinm oat beta glucanm povidone, purified water, sd alcohol 40-2, sodium bicarbonate (baking soda), tea tree oil, vitamine e acetate, zinc acetate

🎯 Purpose 3 words ▾

Purpose Topical Analgesic

📄 Do Not Use 20 words ▾

Do not use on large areas of the body, with any other product containing diphenhydramine, even one taken by mouth

📄 Ask a Doctor Before Use If 9 words ▾

Ask a doctor before use on chicken ox, measles

📄 When Using This Product 8 words ▾

when using this product avoid contact with eyes.

📄 Stop Use and Ask a Doctor If 27 words ▾

Stop use and ask a doctor if condition worses, if symptoms persist for more than 7 days or clear up and occur again within a few days.

📄 Keep Out of Reach of Children 18 words ▾

Keep out of reach of children if swallowed, get medical help or contact poison control center right away.

📄 Package Label / Principal Display Panel 12 words ▾

Itch Eraser Spray Label Primary Packaging

Itch Eraser Spray Box Secondary Packaging

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 Itch Eraser (this brand).

Top reported reactions

Completed Suicide760
Death530
Nausea456
Infusion Related Reaction450
Fatigue443
Dyspnoea408
Pain404

Age at onset

Neonate1
Infant1
Child9
Adolescent8
Adult130
Elderly43

Reporter sex

8,288 reports
Male · 41%
Female · 57%
Unknown · 1%

Serious outcomes

Hospitalization2,703
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 501 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 Tender Corporation d/b/a Adventure Ready Brands. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Tender Corporation d/b/a Adventure Ready Brands 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.
← 44224-1103-02 · Tender 44224-1116-01 · Tender →
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.