Home › NDC Lookup › Ingredients › Diphenhydramine, Zinc Acetate › 47682-0865-70
🧴image loading
(from DailyMed)

Medi First Extra Strength Itch Relief Diphenhydramine, Zinc Acetate .001 g/g; .2 g/g Cream — NDC 47682-865-70 (Billing 47682-0865-70)

by Unifirst First Aid Corporation · 4 TUBE in 1 BOX / 35 g in 1 TUBE

This is a package of Medi First Extra Strength Itch Relief Diphenhydramine, Zinc Acetate .001 g/g; .2 g/g Cream from Unifirst First Aid Corporation, marketed since Nov 2025 and currently FDA-listed.

NDC 47682-0865-70
🏷️ FDA NDC (as labeled) 47682-865-70 billing pads the product segment with a zero
This package
Contains35 g in 1 tube Pack sizes2 compare ↓
Product page 47682-0865-29 Also comes in: 35 tubes 47682-865-29
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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) 47682-865-70
Product NDC 47682-865
11-digit billing NDC 47682086570
UNII FM5526K07A, TC2D6JAD40
UPC 0347682584290
Application # M017
SPL Set ID 54614e5b-8c72-d308-e063-6294a90a405d
Established class (EPC) Copper Absorption Inhibitor; Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-01
Route TOPICAL
Dosage form CREAM
Substance ZINC ACETATE; DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 47682-865-70 — 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 → 47682-0865-70. 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.

Clinical

🧪 What is this product?

Medi First Extra Strength Itch Relief is a topical cream containing diphenhydramine hydrochloride and zinc acetate. Diphenhydramine is an antihistamine commonly used in over-the-counter products to help relieve itching and minor skin irritation. Zinc acetate functions as an astringent and is typically included to help soothe and protect the skin. This is an OTC monograph drug, meaning it is marketed under FDA's established guidelines for nonprescription itch-relief creams rather than as an individually reviewed product application.

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 gPer 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: 35 tubes
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
47682-0865-29 47682-865-29 Main listing 35.4 TUBE in 1 BOX / 35 g in 1 TUBE 2025-11-01 — Active
47682-0865-70 You're viewing this 4 TUBE in 1 BOX / 35 g in 1 TUBE 2025-11-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 4 tube in 1 box / 35 g in 1 tube.
What NDC number is used to bill for this package of Medi First Extra Strength Itch Relief Diphenhydramine, Zinc Acetate .001 g/g; .2 g/g Cream?
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
Medi First Extra Strength Itch Relief .001 g/g; .2 g/gthis 47682-0865-70 Unifirst 4 tubes — — 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerUnifirst First Aid Corporation
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code47682
First marketedNov 2025
Product typeHuman Otc Drug
Portfolio183 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 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 43 words ▾

Uses Uses Temporary relievies pain and itching associated with: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak and poison sumac Dries the oozing and weeping of poison ivy, poison oak, and poison sumac

⏱️ Dosage and Administration 42 words ▾

Directions Directions do not use more than directed adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily for children under 2 years of age: do not use, consult a doctor

⚠️ Warnings 6 words ▾

Warnings Warnings For external use only.

🧪 Active Ingredient 10 words ▾

Active Ingredient Active Ingredient Diphenhydramine Hydrochloride 2% Zinc Acetate 0.1%

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients Inactive ingredients Carbomer homopolymer type C, cetyl alcohol, glycerin, glyceryl monostearate, light mineral oil, methyparaben, polysorbate 60, proplyparaben, purified water, stearic acid

🎯 Purpose 6 words ▾

Purpose Purpose Topical Analgesic Skin Protectant

📄 Do Not Use 23 words ▾

Do not use 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 15 words ▾

Ask a doctor before use Ask a doctor before use on chicken pox on measles

📄 Stop Use and Ask a Doctor If 40 words ▾

Stop use and ask a doctor if Stop use and ask a doctor if condition worsens or does not improve withn 7 days symptoms persist for more than 7 days or clear up and occur again within a few days

📄 Keep Out of Reach of Children 24 words ▾

Keep our of reach of children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

📄 Other Information 19 words ▾

Other information Other information Store between 15°-30° *(59°-86°F) Lot No. & Exp Date: See box or crimp of tube.

📄 Questions or Comments 8 words ▾

Questions or comments? Questions or comments? Call 1-800-635-7680

📄 Package Label / Principal Display Panel 55 words ▾

Principal Display Panel Medi ♥ First Topical Solutions healing made easy NDC #47682-865-29 Histamine Blocker Extra Strength Itch Relief Temporary relief from pain and itching caused by insect bites, minoir burns, sunburn, rashes due to poison ivy, oak, sumac and more *Compare to the Active Ingredients in Extra Strength Benadryl® Cream 58429 Anti-Itch Cream 1-29-26

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Medi First Extra Strength Itch Relief (this brand).

Top reported reactions

Cytokine Release Syndrome1
Death1
Encephalopathy1
Petechiae1
Staphylococcal Sepsis1

Reporter sex

0 reports

Serious outcomes

Death2
Hospitalization1
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1 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 — 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.
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 Unifirst First Aid Corporation. 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 35 tubes (47682-0865-29). 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?
Unifirst First Aid Corporation 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.
← 47682-0864-28 · Unifirst 47682-0866-66 · Unifirst →
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.