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Calamine 80 mg/mL; 10 mg/mL Lotion, 177 mL — NDC 83324-0053-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Calamine 80 mg/mL; 10 mg/mL Lotion, 177 mL — NDC 83324-053-06 (Billing 83324-0053-06)

by Chain Drug Marketing Association · 177 mL in 1 BOTTLE, PLASTIC

This is a package of 177 mL of Calamine 80 mg/mL; 10 mg/mL Lotion from Chain Drug Marketing Association, marketed since Feb 2025 and currently FDA-listed; retail pharmacies pay about $0.0167 per mL (NADAC). It is this product's only package size.

NDC 83324-0053-06
🏷️ FDA NDC (as labeled) 83324-053-06 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 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) 83324-053-06
Product NDC 83324-053
11-digit billing NDC 83324005306
NCPDP billing unit ML — per mL (volume)
RxCUI 1234532
UNII 1K09F3G675, 88AYB867L5
Application # M016
SPL Set ID 6c848b98-f01c-40f2-a9aa-2af76cb370c8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-26
Route TOPICAL
Dosage form LOTION
Substance FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 022061
GCN 65328
HICL code 010079
Ingredient (HICL) Pramoxine Hcl/Calamine
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L3
Therapeutic class — intermediate (HIC2) Protectives
HIC3 code L3P
Therapeutic class — specific (HIC3) Antipruritics,Topical
AHFS code 84:08.00.00
AHFS class Antipruritics And Local Anesthetics
FDB label name QC CALAMINE MEDICATED LOTION
FDB brand name Calamine Medicated
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 022061
  • GCN: 65328
  • HICL (First Databank): 010079
  • AHFS class code: 84:08.00.00
  • RxCUI (RxNorm): 1234532
Why two NDCs? The FDA registers this code as 83324-053-06 — 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 → 83324-0053-06. 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

Label name QC CALAMINE MEDICATED LOTION Ingredient Pramoxine Hcl/Calamine
🧪 What is this product?

Calamine 80 mg/mL; 10 mg/mL Lotion is an over-the-counter topical product marketed under FDA's monograph rules for skin-soothing lotions. The ferric oxide red (calamine) functions as a skin protectant and is commonly used to help relieve minor itching and irritation from insect bites, poison ivy, or dry skin. Pramoxine hydrochloride is a topical anesthetic numbing agent typically included to provide temporary relief from itching and minor pain when applied to the skin.

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 $0.017 $2.96 / 177 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.017 $0.015
▲ Up 8% over the last 10 months.
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
83324-0053-06 You're viewing this Main listing 177 mL in 1 BOTTLE, PLASTIC 2025-02-26 — 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 save 17%
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/mLthis 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/mL 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

🏛️
2025
On the market since
Feb 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.

💡 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII N20HL7Q941
    Camphor is a waxy, aromatic substance derived from camphor tree wood or made synthetically. In medicines, it typically serves as a preservative, flavoring agent, or mild skin irritant in topical products.
  • 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 ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • 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 8LGU7VM393
    Rosemary leaf oil is a natural aromatic oil extracted from rosemary plants. It's used in medicines as a flavoring agent and preservative to help protect the product from spoilage.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesalcohol, benzyl alcohol, camphor, fragrance, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, phenoxyethanol, polysorbate 80, propylene glycol, Rosmarinus officinalis (rosemary) leaf oil, water, xanthan gum

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

LabelerChain Drug Marketing Association
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code83324
First marketedFeb 2025
Product typeHuman Otc Drug
Portfolio128 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 🤒 Adverse Reactions 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 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 35 words ▾

Uses for the temporary relief of pain and itching associated with minot skin irritations and rashes due to poison ivy, poison oak, or poison sumac dries the oozing and weeping of poison: ivy oak sumac

⏱️ Dosage and Administration 45 words ▾

Directions shake well before applying was affected are of skin 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 - do not use, ask a doctor

⚠️ Warnings 5 words ▾

Warnings For external use only

🤒 Adverse Reactions 16 words ▾

ADVERSE REACTION Distributed by CDMA, Inc. Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 SATISFACTION GUARANTEED 100% QC

📦 Storage and Handling 7 words ▾

Other information store at room temperature (59°-77°F)

🧪 Active Ingredient 7 words ▾

Active ingredients Calamine 8% Pramoxine HCl 1%

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients alcohol, benzyl alcohol, camphor, fragrance, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, phenoxyethanol, polysorbate 80, propylene glycol, Rosmarinus officinalis (rosemary) leaf oil, water, xanthan gum

🎯 Purpose 5 words ▾

Purpose Skin protectant External analgesic

📄 When Using This Product 9 words ▾

When using this product do not get into eyes

📄 Stop Use and Ask a Doctor If 24 words ▾

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

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Package Label / Principal Display Panel 44 words ▾

PRINCIPAL DISPLAY PANEL NDC 83324-053-06 QC QUALITY CHOICE *Compare to CALADRYL Medicated Calamine Lotion External Analgesic/Skin Protectant For relief from pain and itching due to: Poison Ivy, Poison Sumac, Insect Bites, Poison Oak & Minor Skin Irritations 6 FL OZ (177 mL) image description

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 83324-0052-01 · Chain 83324-0054-24 · Chain →
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.