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Calamine FERRIC OXIDE RED 8 g/mL; 8 mg/mL Lotion, 177 mL — NDC 68788-0292-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Calamine FERRIC OXIDE RED 8 g/mL; 8 mg/mL Lotion, 177 mL — NDC 68788-0292-1 (Billing 68788-0292-01)

by Preferred Pharmaceuticals Inc. · 177 mL in 1 BOTTLE, PLASTIC

This is a package of 177 mL of Calamine FERRIC OXIDE RED 8 g/mL; 8 mg/mL Lotion from Preferred Pharmaceuticals Inc., marketed since Apr 2018 and currently FDA-listed. It is this product's only package size.

NDC 68788-0292-01
🏷️ FDA NDC (as labeled) 68788-0292-1 billing pads the package 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 →

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 68788-0292-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68788 labeler · 0292 product · 1 package
Package marketed since
Apr 19, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
177 mL per package
Barcode (UPC-A, from the NDC)
3 6878802921 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68788-0292-1
Product NDC 68788-0292
11-digit billing NDC 68788029201
NCPDP billing unit ML — per mL (volume)
RxCUI 617954
UNII 1K09F3G675, SOI2LOH54Z
Application # 347
SPL Set ID 326f3d80-c1bf-4cf0-a662-58e02ed7ee67
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-04-19
Route TOPICAL
Dosage form LOTION
Substance FERRIC OXIDE RED; ZINC OXIDE

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

GPI-14 90979902204100
GPI class Calamine
Quick answers
  • GPI-14 (Medi-Span): 90979902204100
  • RxCUI (RxNorm): 617954
Why two NDCs? The FDA registers this code as 68788-0292-1 — a 5-4-1 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 package segment → 68788-0292-01. 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?

This is an over-the-counter topical lotion containing zinc oxide and ferric oxide red. It is an OTC monograph product, meaning it is marketed under FDA's established rules for this category of product rather than through individual application review. Zinc oxide and ferric oxide red are commonly used together in skin-care lotions as protective and soothing agents for minor skin irritation and discomfort. The lotion is applied directly 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 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
68788-0292-01 You're viewing this Main listing 177 mL in 1 BOTTLE, PLASTIC 2018-04-19 — 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/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/mLthis 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

🏛️
2018
On the market since
Apr 2018
📍
2026
Currently FDA-listed
8 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 PF5DZW74VN
    Calcium hydroxide is a white powder made from limestone. It's used in medicines as a buffer to adjust acidity and as a disintegrant to help tablets break apart in the stomach.
  • 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, 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

LabelerPreferred Pharmaceuticals Inc.
FDA application347 (OTC MONOGRAPH DRUG)
Labeler code68788
First marketedApr 2018
Product typeHuman Otc Drug
Portfolio833 products on file

More NDCs from Preferred Pharmaceuticals Inc. labeler code 68788

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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

Use dries the oozing and weeping of poison:•ivy • oak • sumac

⏱️ Dosage and Administration 10 words ▾

Directions • shake well before using • apply as needed

⚠️ Warnings 5 words ▾

Warnings For external use only

🤒 Adverse Reactions 27 words ▾

Adverse reactions Distributed By: MAJOR PHARMACEUTICALS 17177 N LAUREL PARK DRIVE, SUITE 233 Livonia, MI 48152 Re-Order No 014282 M-97 Rev. 10/16 Relabeled By: Preferred Pharmaceuticals Inc.

📦 Storage and Handling 8 words ▾

Other information store at 59⁰ - 86⁰ F

🧪 Active Ingredient 7 words ▾

Active ingredents Calamine 8% 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 9 words ▾

When using this product Do not get into eyes

📄 Stop Use and Ask a Doctor If 27 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 19 words ▾

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

📄 Questions or Comments 5 words ▾

Questions or comments? (800) 616-2471

📄 Package Label / Principal Display Panel 31 words ▾

principal display panel NDC 68788-0292-1 MAJOR Calamine Lotion Calamine Topical Suspension USP Skin Protectant Poison Ivy, Oak, Sumac Drying Lotion Shake well before using 6 FL OZ (177 mL) Calamine Lotion

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 ✓ 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 Preferred Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Preferred Pharmaceuticals Inc. 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.
← 68788-0142-01 · Preferred 68788-0483-01 · Preferred →
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.