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Quality Choice Calamine Calamine 8% and Zinc Oxide 160 mg/mL Lotion, 177 mL — NDC 63868-0317-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Quality Choice Calamine Calamine 8% and Zinc Oxide 160 mg/mL Lotion, 177 mL — NDC 63868-317-06 (Billing 63868-0317-06)

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

This is a package of 177 mL of Quality Choice Calamine Calamine 8% and Zinc Oxide 160 mg/mL Lotion from Chain Drug Market Association, marketed since Mar 1998 and currently FDA-listed; retail pharmacies pay about $0.0091 per mL (NADAC). It is this product's only package size.

NDC 63868-0317-06
🏷️ FDA NDC (as labeled) 63868-317-06 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 →

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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 63868-317-06 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63868 labeler · 317 product · 06 package
Package marketed since
Dec 12, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
177 mL per package
Barcode (UPC-A, from the NDC)
3 6386831706 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63868-317-06
Product NDC 63868-317
11-digit billing NDC 63868031706
NCPDP billing unit ML — per mL (volume)
RxCUI 617954
UNII SOI2LOH54Z
Application # M016
SPL Set ID 62fe653f-e861-472b-b193-4fdd9d25de8d
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 1998-03-25
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE

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

GPI-14 90971010004100
GPI class QC Calamine
GCN Seq No 061802
GCN 97587
HICL code 002304
Ingredient (HICL) Calamine/Zinc Oxide
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L3
Therapeutic class — intermediate (HIC2) Protectives
HIC3 code L3A
Therapeutic class — specific (HIC3) Protectives
AHFS code 84:24.04.00
AHFS class Basic Lotions And Liniments
FDB label name QC CALAMINE LOTION
FDB brand name Calamine
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 061802
  • GCN: 97587
  • GPI-14 (Medi-Span): 90971010004100
  • HICL (First Databank): 002304
  • AHFS class code: 84:24.04.00
  • RxCUI (RxNorm): 617954
Why two NDCs? The FDA registers this code as 63868-317-06 — 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 → 63868-0317-06. 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 LOTION Ingredient Calamine/Zinc Oxide
🧪 What is this product?

Quality Choice Calamine is a topical lotion that contains zinc oxide as its active ingredient. This product is an over-the-counter monograph drug, meaning it follows FDA's established safety and use guidelines for this category. Zinc oxide is commonly used in skin care lotions to help soothe and protect irritated skin, and it functions as a mild astringent and protectant. This lotion is applied directly to the skin surface.

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 $0.009 $1.61 / 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 2021 Mar 2022 Jul 2022 Nov 2022 $0.009 $0.008
▲ Up 10% over the last 12 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
63868-0317-06 You're viewing this Main listing 177 mL in 1 BOTTLE, PLASTIC 2017-12-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Quality Choice Calamine 160 mg/mLthis 63868-0317-06 Chain 177 ml $0.009 — FDA listed —
Calamine 80 mg/mL; 80 mg/mL 00904-2533-21 Major 177 ml $0.011 — Availability likely +21%
GNP Calamine Topical Suspension 160 mg/mL 24385-0413-96 Amerisource 177 ml $0.011 — Availability likely +21%
Calamine 80 mg/100mL; 80 mg/100mL 46122-0809-29 AMERISOURCE 177 ml $0.011 — Availability likely +21%
Sunmark Calamine 160 mg/mL 49348-0011-34 Strategic 177 ml $0.011 — Availability likely +21%
Health Mart Calamine 160 mg/mL 62011-0114-01 Strategic 177 ml $0.011 — Availability likely +21%
Calamine 80 mg/mL; 80 mg/mL 70677-1196-01 Strategic 177 ml $0.011 — Availability likely +21%
calamine 160 mg/mL 70677-1316-01 STRATEGIC 177 ml $0.011 — Availability likely +21%
Calamine 80 mg/mL; 80 mg/mL 83324-0248-06 Chain 177 ml $0.011 — Availability likely +21%
calamine 160 mg/mL 00363-9410-97 WALGREEN 177 ml — — FDA listed —
Humco Calamine 160 mg/mL 00395-0413-96 Humco 177 ml — — FDA listed —
Calamine 80 mg/mL; 80 mg/mL 11344-0063-30 Nice-Pak 177 ml — — FDA listed —
Calamine 80 mg/mL; 80 mg/mL 11673-0063-30 Target 177 ml — — FDA listed —
Rite Aid Calamine 160 mg/mL 11822-4352-09 Rite 177 ml — — FDA listed —
Calamine 80 mg/mL; 80 mg/mL 21130-0941-30 Better 177 ml — — FDA listed —
Calamine 8 g/mL; 8 g/mL 30142-0063-30 The 177 ml — — FDA listed —
Assured Calamine 160 mg/mL 33992-4130-06 Greenbriar 177 ml — — FDA listed —
Calamine 80 mg/mL; 80 mg/mL 36800-0063-30 Topco 177 ml — — FDA listed —
TopCare Calamine 160 mg/mL 36800-0702-96 TOPCO 177 ml — — FDA listed —
Calamine, Zinc Oxide 80 mg/mL; 80 mg/mL 37808-0621-30 H 177 ml — — FDA listed —
Calamine 160 mg/mL 49035-0413-96 Wal-Mart 177 ml — — FDA listed —
DDM Calamine 160 mg/mL 53943-0413-96 Discount 177 ml — — FDA listed —
Calamine 80 mg/mL; 80 mg/mL 55301-0063-30 Your 177 ml — — FDA listed —
Calamine 80 mg/mL; 80 mg/mL 55319-0063-30 Family 177 ml — — FDA listed —
Calamine 80 mg/mL; 80 mg/mL 55910-0063-30 Old 177 ml — — FDA listed —
Health Care Calamine 160 mg/mL 64092-0413-96 Great 177 ml — — FDA listed —
Premiere Value Calamine 160 mg/mL 68016-0413-96 Chain 177 ml — — FDA listed —
Calamine 8 g/mL; 8 mg/mL 68071-4322-06 NuCare 177 ml — — FDA listed —
Calamine 8 g/mL; 8 mg/mL 68788-0292-01 Preferred 177 ml — — FDA listed —
Harris Teeter Calamine 160 mg/mL 69256-0413-96 Harris 177 ml — — FDA listed —
Calamine 80 mg/mL; 80 mg/mL 72476-0063-30 Retail 177 ml — — FDA listed —
Calamine 8 mg/mL; 8 mg/mL 75981-0063-30 Perrigo 177 ml — — FDA listed —
RID Poison Ivy Rash Relief 80 mg/mL; 80 mg/mL 82392-0300-01 Oystershell 177 ml — — FDA listed —
Calamine 80 mg/mL; 80 mg/mL 82645-0418-96 Pharma 177 ml — — FDA listed —
Calamine 160 mg/mL 82645-0900-96 Pharma 177 ml — — FDA listed —
Calamine 80 mg/mL; 80 mg/mL 85786-0703-06 Farmacias 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

🏛️
1998
On the market since
Mar 1998
📍
2026
Currently FDA-listed
28 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.

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

LabelerChain Drug Market Association
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code63868
First marketedMar 1998
Product typeHuman Otc Drug
Portfolio9 products on file

More NDCs from Chain Drug Market Association labeler code 63868

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 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

Uses dries the oozing and weeping o poison ivy, poison oak, and poison sumac.

⏱️ Dosage and Administration 57 words ▾

Directions Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort. Children under 6 months of age: Consult a doctor before use.

⚠️ Warnings 27 words ▾

Warnings For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Ask a doctor before using on chilren 6 months of age.

🧪 Active Ingredient 8 words ▾

Active Ingredients Calamine 8% and Zinc Oxide 8%

🧪 Inactive Ingredients 9 words ▾

Inactive ingredients Bentonite magma, calcium hydroxide, glycerin, purified water.

🎯 Purpose 3 words ▾

Purpose Skin protectant

📄 When Using This Product 20 words ▾

When using this product Discontinue use if condition worsens or does not improve within 7 days and consult a doctor.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately.

📄 Other Information 8 words ▾

Other information Store at room temperature 13-30C (50-86F)

📄 Package Label / Principal Display Panel 5 words ▾

Package Principal Display Panel Capture

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 Calamine 8% and Zinc Oxide 8% — the ingredient across all brands.

Top reported reactions

Rash72
Diarrhoea59
Fatigue53
Pruritus47
Constipation42
Nausea36
Dizziness35

Age at onset

Neonate1
Infant1
Child3
Adolescent1
Adult55
Elderly40

Reporter sex

439 reports
Male · 40%
Female · 60%

Serious outcomes

Hospitalization184
Life-threatening26
Disabling9
Reports over time (by year) — tap or hover for the count & year
2025 2026 40 18
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.
← 63868-0310-12 · Chain 63868-0322-06 · 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.