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Premiere Value Calamine Calamine 8% and Zinc Oxide 160 mg/mL Lotion, 177 mL — NDC 68016-0413-96 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Premiere Value Calamine Calamine 8% and Zinc Oxide 160 mg/mL Lotion, 177 mL — NDC 68016-413-96 (Billing 68016-0413-96)

by Chain Drug Consortium · 177 mL in 1 BOTTLE, PLASTIC

This is a package of 177 mL of Premiere Value Calamine Calamine 8% and Zinc Oxide 160 mg/mL Lotion from Chain Drug Consortium, marketed since Jan 2008 and currently FDA-listed. It is this product's only package size.

NDC 68016-0413-96
🏷️ FDA NDC (as labeled) 68016-413-96 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 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

NDC database record

One package, one record: these facts belong to NDC 68016-413-96 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68016 labeler · 413 product · 96 package
Package marketed since
Oct 27, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0840986012952
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68016-413-96
Product NDC 68016-413
11-digit billing NDC 68016041396
RxCUI 617954
UNII SOI2LOH54Z
UPC 0840986012952
Application # M016
SPL Set ID 5c8bde5a-591d-085f-e053-2991aa0a56af
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 2008-01-01
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Quick answers
  • RxCUI (RxNorm): 617954
Why two NDCs? The FDA registers this code as 68016-413-96 — 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 → 68016-0413-96. 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?

Premiere Value Calamine is a lotion applied to the skin, marketed as an over-the-counter product under FDA monograph rules. Its active ingredient, zinc oxide, is commonly used in topical products to help soothe and protect skin. This lotion is typically used for minor skin irritation, itching, and rashes.

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
68016-0413-96 You're viewing this Main listing 177 mL in 1 BOTTLE, PLASTIC 2017-10-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Quality Choice Calamine 160 mg/mL 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 —
GNP Calamine Topical Suspension 160 mg/mL 24385-0413-96 Amerisource 177 ml $0.011 — Availability likely —
Calamine 80 mg/100mL; 80 mg/100mL 46122-0809-29 AMERISOURCE 177 ml $0.011 — Availability likely —
Sunmark Calamine 160 mg/mL 49348-0011-34 Strategic 177 ml $0.011 — Availability likely —
Health Mart Calamine 160 mg/mL 62011-0114-01 Strategic 177 ml $0.011 — Availability likely —
Calamine 80 mg/mL; 80 mg/mL 70677-1196-01 Strategic 177 ml $0.011 — Availability likely —
calamine 160 mg/mL 70677-1316-01 STRATEGIC 177 ml $0.011 — Availability likely —
Calamine 80 mg/mL; 80 mg/mL 83324-0248-06 Chain 177 ml $0.011 — Availability likely —
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/mLthis 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

🏛️
2008
On the market since
Jan 2008
📍
2026
Currently FDA-listed
18 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.

  • UNII A3N5ZCN45C
    Bentonite is a naturally occurring clay mineral used in medicines as a binder and absorbent. It helps hold tablet ingredients together and can absorb moisture or unwanted substances in the formulation.
  • UNII WY779SQ0XW
    Calcium hydride is a white powder compound containing calcium and hydrogen. In medicines, it's used as a drying agent to remove moisture from formulations, helping maintain stability and prevent degradation of active ingredients.
  • 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 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.

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

The official label also statesBentonite Magma, Calcium Hydroxide, Glycerin, 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

LabelerChain Drug Consortium
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code68016
First marketedJan 2008
Product typeHuman Otc Drug
Portfolio33 products on file

More NDCs from Chain Drug Consortium labeler code 68016

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 📄 Ask a Doctor Before Use If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 18 words ▾

Uses Dries the oozing and weeping of poison ivy, poison oak, and poison sumac and other skin irritations.

⏱️ Dosage and Administration 54 words ▾

Directions Adults and children 6 mo. of age and older: Shake well before using. Cleanse the skin with soap and water. Let dry before each use. Apply lotion to the affected area using cotton or soft cloth, as often as needed for comfort. Children under 6 mo. of age: Consult a doctor before use.

⚠️ Warnings 16 words ▾

Warnings For external use only. Use only as directed. Avoid contat with eyes and moucous membranes.

🧪 Active Ingredient 7 words ▾

active Ingredients Calamine 8% Zinc Oxide 8%

🧪 Inactive Ingredients 10 words ▾

Inactive Ingredients Bentonite Magma, Calcium Hydroxide, Glycerin, and Purified Water.

🎯 Purpose 5 words ▾

Purpose Skin Protectant Skin Protectant

📄 Ask a Doctor Before Use If 38 words ▾

Ask a doctor before using on children under 6 years of age. Stop use and ask a doctor if Condition worsens Symptoms last for more than 7 days or clear up and occur again within a few days.

📄 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 15-30C (59-86F)

📄 Questions or Comments 3 words ▾

Questions or Comments?

📄 Package Label / Principal Display Panel 3 words ▾

Label PV Calamine

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

Reporter sex

0 reports
Male · 40%
Female · 60%

Serious outcomes

Hospitalization184
Life-threatening26
Disabling9
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 41 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 Chain Drug Consortium. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Chain Drug Consortium 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.
← 68016-0400-96 · Chain 68016-0415-00 · 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.