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Calamine 80 mg/100mL; 80 mg/100mL Lotion, 177 mL — NDC 46122-0809-29 package photo

Calamine 80 mg/100mL; 80 mg/100mL Lotion, 177 mL

by AMERISOURCE BERGEN · 177 mL in 1 BOTTLE, PLASTIC (46122-809-29)
NDC 46122-0809-29
🏷️ FDA NDC (as labeled) 46122-809-29 billing pads the product 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 →

🆔 Identity & classification

FDA NDC (as labeled) 46122-809-29
Product NDC 46122-809
11-digit billing NDC 46122080929
NCPDP billing unit ML — per mL (volume)
RxCUI 617954
UNII 1K09F3G675, SOI2LOH54Z
Application # M016
SPL Set ID 90d9d908-57ea-4062-ade0-8a4888939c91
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-23
Route TOPICAL
Dosage form LOTION
Substance FERRIC OXIDE RED; ZINC OXIDE
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 GNP 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 46122-809-29 — 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 → 46122-0809-29. 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

LabelerAMERISOURCE BERGEN
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code46122
First marketedApr 2025
Product typeHuman Otc Drug
Portfolio206 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 GNP CALAMINE LOTION Ingredient Calamine/Zinc Oxide
🧪 What is this product?

Calamine lotion is a topical over-the-counter product containing zinc oxide and ferric oxide red. Zinc oxide is commonly used as a skin protectant and mild astringent in topical preparations. Ferric oxide red is a colorant that gives the lotion its characteristic appearance. This lotion is typically applied to the skin surface to help soothe and dry minor skin irritations such as itching and minor rashes.

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 DailyMedingredient 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 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 Feb 2026 May 2026 Aug 2026 $0.011 $0.010
▲ Up 2% over the last 9 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/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/100mLthis 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

🏛️
2025
On the market since
Apr 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
46122-0809-29 You're viewing this 177 mL in 1 BOTTLE, PLASTIC (46122-809-29) 2025-04-23 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 11 words

Uses 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 23 words

ADVERSE REACTION Distributed By AmerisourceBergen 1 West First Avenue Conshohocken, PA 19428 Questions or Concerns? www.mygnp.com SATISFACTION GUARANTEED GOOD NEIGHBOR PHARMACY BRAND PRODUCTS

🧪 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 ↗
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.