Home › NDC Lookup › Ingredients › Zinc Oxide Lotion › 82645-0420-96
🧴image loading
(from DailyMed)

Freskaro Calamine Plus zinc oxide lotion 80 mg/mL; 10 mg/mL Lotion, 177 mL — NDC 82645-420-96 (Billing 82645-0420-96)

by Pharma Nobis, LLC · 177 mL in 1 BOTTLE, PLASTIC

This is a package of 177 mL of Freskaro Calamine Plus zinc oxide lotion 80 mg/mL; 10 mg/mL Lotion from Pharma Nobis, LLC, marketed since Apr 2026 and currently FDA-listed. It is this product's only package size.

NDC 82645-0420-96
🏷️ FDA NDC (as labeled) 82645-420-96 billing pads the product segment with a zero
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

NDC database record

One package, one record: these facts belong to NDC 82645-420-96 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
82645 labeler · 420 product · 96 package
Package marketed since
Apr 15, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0382645420963
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 82645-420-96
Product NDC 82645-420
11-digit billing NDC 82645042096
RxCUI 1234532
UNII SOI2LOH54Z, 88AYB867L5
UPC 0382645420963
Application # M016
SPL Set ID 4f85bdc7-8fed-f1f5-e063-6394a90a6358
Established class (EPC) Copper Absorption Inhibitor
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 2026-04-15
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1234532
Why two NDCs? The FDA registers this code as 82645-420-96 — 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 → 82645-0420-96. 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?

Freskaro Calamine Plus is a topical lotion marketed as an over-the-counter product under FDA's monograph rules for its category. It contains pramoxine hydrochloride, a local anesthetic commonly used to numb minor skin irritation, and zinc oxide, which typically functions as a skin protectant and mild astringent in topical products. This combination is commonly used in lotions intended to help soothe itching and minor skin discomfort from sources like insect bites, rashes, or sunburn.

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.
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
82645-0420-96 You're viewing this Main listing 177 mL in 1 BOTTLE, PLASTIC 2026-04-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sunmark Caldiphen 80 mg/mL; 10 mg/mL 49348-0337-36 Strategic 177 ml $0.014 — FDA listed —
GNP Caldyphen 80 mg/mL; 10 mg/mL 24385-0072-82 Amerisource 177 ml $0.017 — Availability likely —
Leader Calamine Plus 80 mg/mL; 10 mg/mL 70000-0400-01 Cardinal 177 ml $0.017 — Availability likely —
Foster and Thrive Caldyphen 80 mg/mL; 10 mg/mL 70677-1198-01 Strategic 177 ml $0.017 — Availability likely —
Calamine 80 mg/mL; 10 mg/mL 83324-0053-06 Chain 177 ml $0.017 — Availability likely —
Caladryl 1.36 mg/mL; 78.65 mg/mL; 10 mg/mL 00187-5465-06 Bausch 177 ml — — FDA listed —
calahist 10 mg/mL; 80 mg/mL 00363-9411-97 WALGREEN 177 ml — — FDA listed —
Humco Calagesic 80 mg/mL; 10 mg/mL 00395-0420-96 Humco 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 11344-0136-30 Nice-Pak 177 ml — — FDA listed —
TopCare Calagesic 80 mg/mL; 10 mg/mL 36800-0268-96 TOPCO 177 ml — — FDA listed —
Calamine, Pramoxind HCl 80 mg/mL; 10 mg/mL 37808-0616-30 H 177 ml — — FDA listed —
HEB Calagesic 80 mg/mL; 10 mg/mL 37808-0968-96 H 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 41163-0536-30 United 177 ml — — FDA listed —
Publix Calamine Medicated 80 mg/mL; 10 mg/mL 41415-0420-96 Publix 177 ml — — FDA listed —
Best Choice Medicated Calamine 80 mg/mL; 10 mg/mL 63941-0420-96 Valu 177 ml — — FDA listed —
CVS Calamine Plus 80 mg/mL; 10 mg/mL 69842-0420-96 CVS 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 72288-0436-30 Amazon.com 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 75981-0336-30 Perrigo 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 76162-0336-30 Topco 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 79481-0336-01 Meijer, 177 ml — — FDA listed —
Freskaro Calamine Plus 80 mg/mL; 10 mg/mLthis 82645-0420-96 Pharma 177 ml — — FDA listed —
Humco Calagesic 80 mg/mL; 10 mg/mL 82645-0922-96 Pharma 177 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

🏛️
2026
On the market since
Apr 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.

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 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.
  • UNII 5TJD82A1ET
    A cooling crystalline substance made synthetically that is added to medicines as a fragrance, flavoring agent, and mild local irritant to produce a cooling or warming sensation on the skin or mucous membranes.
  • UNII H5RIZ3MPW4
    A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • 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 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • 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.

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

The official label also statesSH Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hypromellose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparabaren and Purified water

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

LabelerPharma Nobis, LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code82645
First marketedApr 2026
Product typeHuman Otc Drug
Portfolio40 products on file

More NDCs from Pharma Nobis, LLC labeler code 82645

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 📄 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 24 words ▾

Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac or other minor skin irritations.

⏱️ Dosage and Administration 61 words ▾

Adults and children 2 years of age and older: Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort. Children under 2 years of age: do not use, consult a doctor.

⚠️ Warnings 15 words ▾

For external use only. Use only as directed. Avoid contact with eyes and mucous membranes,

🧪 Active Ingredient 5 words ▾

Calamine 8% Pramoxine HCl 1%

🧪 Inactive Ingredients 19 words ▾

SH Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hypromellose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparabaren and Purified water

🎯 Purpose 4 words ▾

Skin Protectant External Analgesic

📄 Stop Use and Ask a Doctor If 25 words ▾

Stop use and ask a doctor if condition worsens symptoms last more than 7 days, or clear up and occur again within a few days

📄 Keep Out of Reach of Children 23 words ▾

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) right away.

📄 Other Information 12 words ▾

Other information Store at room temperature 15 - 30C (59 - 86F)

📄 Questions or Comments 4 words ▾

Questions or Comments? 1-833-551-0932

📄 Package Label / Principal Display Panel 4 words ▾

Freskaro Calamine Plus 2026

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

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) ✓ 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 Pharma Nobis, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pharma Nobis, LLC 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.
← 82645-0418-96 · Pharma 82645-0515-96 · Pharma →
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.