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Calamine FERRIC OXIDE RED 80 mg/mL; 80 mg/mL Lotion, 177 mL — NDC 00904-2533-21 package photo

Calamine FERRIC OXIDE RED 80 mg/mL; 80 mg/mL Lotion, 177 mL

by Major Pharmaceuticals · 177 mL in 1 BOTTLE, PLASTIC (0904-2533-21)
NDC 00904-2533-21
🏷️ FDA NDC (as labeled) 0904-2533-21 billing pads the labeler segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 0904-2533-21
Product NDC 0904-2533
11-digit billing NDC 00904253321
NCPDP billing unit ML — per mL (volume)
RxCUI 617954
UNII 1K09F3G675, SOI2LOH54Z
Application # M016
SPL Set ID c25be68d-834a-4959-8d47-01ec789406ba
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-01-07
Route TOPICAL
Dosage form LOTION
Substance FERRIC OXIDE RED; ZINC OXIDE
GPI-14 90979902204100
GPI class 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 CALAMINE LOTION
FDB brand name Calamine
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0904-2533-21 — a 4-4-2 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 labeler segment → 00904-2533-21. 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.

🏭 Manufacturer & labeler

LabelerMajor Pharmaceuticals
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code00904
First marketedJan 2013
Product typeHuman Otc Drug
Portfolio629 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.

🩺 Clinical

Label name CALAMINE LOTION Ingredient Calamine/Zinc Oxide
🧪 What is this product?

This is an over-the-counter topical lotion marketed under FDA's OTC monograph rules for skin protectants and astringents. It contains ferric oxide red and zinc oxide, which are mineral ingredients commonly used in lotions applied to the skin to help soothe minor irritation, reduce oozing, and form a protective barrier. Products of this type are typically used for minor skin conditions such as rashes, insect bites, or localized inflammation.

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.

🧪 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.

💲 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 $0.011 $1.95 / 177 ml
Medicaid paysCMS SDUD · 12 mo $0.3908 $69.17 / 177 ml
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 Jul 2022 Dec 2025 Aug 2026 $0.011 $0.008
▲ Up 33% over the last 23 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Quality Choice Calamine 160 mg/mL 63868-0317-06 Chain 177 ml $0.009 — FDA listed save 18%
Calamine 80 mg/mL; 80 mg/mLthis 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/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

🏛️
2013
On the market since
Jan 2013
📍
2026
Currently FDA-listed
13 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00904-2533-21, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2.9K
Units reimbursed last 4 qtrs
521.1K
Gross reimbursed last 4 qtrs
$203.7K
Avg / prescription
$69.49
Avg / unit
$0.3908
Latest quarter Q4 2025
954Rx
Medicaid pays / mL
$0.3908
gross reimbursed
vs
NADAC / mL
$0.0110
acquisition cost
=
Spread
+$0.3798
+3453% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
32% FFS 68% MCO
Fee-for-service · 932 Rx Managed care · 1,999 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 59,061 units · 1,029 per 100k residents MN Wisconsin: 7,257 units · 123 per 100k residents WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 100,948 units · 857 per 100k residents OH Pennsylvania: 10,449 units · 80.6 per 100k residents PA New Jersey: 163,586 units · 1,761 per 100k residents NJ Massachusetts: 23,843 units · 341 per 100k residents MA California: 86,979 units · 223 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 20,886 units · 240 per 100k residents VA Maryland: 5,487 units · 88.8 per 100k residents MD Connecticut: no data reported CT Rhode Island: 14,868 units · 1,358 per 100k residents RI Arizona: 11,241 units · 151 per 100k residents AZ New Mexico: 1,997 units · 94.5 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 14,514 units · 1,011 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
80.61,761
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Jersey 1,761 /100k
2 Rhode Island 1,358 /100k
3 Minnesota 1,029 /100k
4 Hawaii 1,011 /100k
5 Ohio 857 /100k
6 Massachusetts 341 /100k
7 Virginia 240 /100k
8 California 223 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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 (this brand).

Top reported reactions

Rash72
Diarrhoea59
Fatigue53
Pruritus47
Constipation43
Nausea37
Dizziness35

Reporter sex

446 reports
Male · 40%
Female · 60%
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 44 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00904-2533-21 You're viewing this 177 mL in 1 BOTTLE, PLASTIC (0904-2533-21) 2013-01-07 Active

📄 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
🎯 Indications and Usage 11 words ▾

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

⏱️ Dosage and Administration 8 words ▾

Directions shake well before using apply as needed

⚠️ Warnings 5 words ▾

Warnings For external use only

🤒 Adverse Reactions 19 words ▾

Adverse reactions Distributed By: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Rev. 03/25 M-97 Re-order No. 014283

📦 Storage and Handling 8 words ▾

Other information store at 59⁰ - 86⁰ F

🧪 Active Ingredient 7 words ▾

Active ingredients Calamine 8% Zinc oxide 8%

🧪 Inactive Ingredients 9 words ▾

Inactive ingredients bentonite magma, calcium hydroxide, glycerin, purified water

🎯 Purpose 3 words ▾

Purpose Skin Protectant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00904-2500-91 · Major 00904-2725-61 · Major →
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.