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Calamine Plus .345 mg/116g; 24.16 mg/116g; 2.72 mg/116g Aerosol, Spray, 116 g — NDC 46122-0745-31 package photo

Calamine Plus .345 mg/116g; 24.16 mg/116g; 2.72 mg/116g Aerosol, Spray, 116 g

by AmerisourceBergen Drug Corporation · 116 g in 1 CANISTER (46122-745-31)
NDC 46122-0745-31
🏷️ FDA NDC (as labeled) 46122-745-31 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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) 46122-745-31
Product NDC 46122-745
11-digit billing NDC 46122074531
NCPDP billing unit GM — per gram (weight)
RxCUI 1544717
UNII 1K09F3G675, SOI2LOH54Z, 88AYB867L5
Application # M017
SPL Set ID f161e151-4fab-2fbc-e053-2a95a90a5437
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-01-03
Route TOPICAL
Dosage form AEROSOL, SPRAY
Substance FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
GCN Seq No 084632
GCN 53981
HICL code 010079
Ingredient (HICL) Pramoxine Hcl/Calamine
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L3
Therapeutic class — intermediate (HIC2) Protectives
HIC3 code L3P
Therapeutic class — specific (HIC3) Antipruritics,Topical
AHFS code 84:08.00.00
AHFS class Antipruritics And Local Anesthetics
FDB label name GNP CALAMINE PLUS 8%-1% SPRAY
FDB brand name Calamine Plus
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 46122-745-31 — 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 → 46122-0745-31. 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

LabelerAmerisourceBergen Drug Corporation
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code46122
First marketedJan 2023
Product typeHuman Otc Drug
Portfolio37 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 PLUS 8%-1% SPRAY Ingredient Pramoxine Hcl/Calamine
🧪 What is this product?

Calamine Plus is an over-the-counter topical spray marketed under FDA's monograph rules for skin-care products. It contains calamine (ferric oxide red and zinc oxide), which are typically used to help soothe minor skin irritation, itching, and minor burns or insect bites. The spray also contains pramoxine hydrochloride, a local anesthetic commonly used to temporarily numb minor skin pain and itching. This product 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.

🧪 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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 5TJD82A1ET
    A cooling crystalline substance made synthetically that is added to medicines as a fragrance, flavoring agent, and mild local irritant to produce a cooling or warming sensation on the skin or mucous membranes.
  • UNII X687XDK09L
    A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
  • UNII Y6O7T4G8P9
    Hydrated silica is a fine powder form of silicon dioxide with absorbed water. It works as an anti-caking agent and absorbent in medicines, helping powders stay free-flowing and preventing clumping.
  • UNII BXR49TP611
    Isobutane is a liquefied gas used as a propellant in aerosol inhalers and sprays. It helps push the medicine out of the container so you can breathe or spray it as directed.
  • UNII 172F2WN8DV
    A fatty alcohol derived from animal or plant oils. It acts as an emollient and helps stabilize emulsions, allowing oil and water to mix evenly in the medication.
  • UNII QE6F49RPJ1
    A natural oil derived from sorbitol and oleic acid. It works as an emulsifier and solubilizer to help mix oil and water-based ingredients together and improve how the medicine dissolves or spreads in the body.

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

The official label also statesbenzyl alcohol, camphor, disteardimonium hectorite, fragrance, hydrated silica, isobutane, oleyl alcohol, SD alcohol 40-B, sorbitan trioleate

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 gPer package
Retail pharmacies payNADAC · weekly $0.043 $5.03 / 116 g
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 g) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.044 $0.043
Flat 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
Calamine Plus .345 mg/116g; 24.16 mg/116g; 2.72 mg/116gthis 46122-0745-31 AmerisourceBergen 116 g $0.043 — Availability likely —
Calamine Plus 5 mg/g; 10 mg/g; 79.5 mg/g 83324-0242-41 Chain 116 g $0.043 — Availability likely —
Calamine Plus Pramoxine HCl .345 mg/177mL; 24.16 mg/177mL; 2.72 mg/177mL 00363-8588-41 Walgreens 177 ml — — FDA listed —
Calamine Plus Pramoxine HCl .345 mg/116g; 24.16 mg/116g; 2.72 mg/116g 30142-0156-06 Kroger 116 g — — FDA listed —
Calamine Plus 79.6 mg/g; 10 mg/g; .4 mg/g 30142-0429-41 Kroger 116 g — — FDA listed —
Calamine Plus Pramoxine HCl .345 mg/116g; 24.16 mg/116g; 2.72 mg/116g 36800-0398-41 Topco 116 g — — FDA listed —
Calamine Plus Pramoxine HCL .345 mg/116g; 2.72 mg/116g; 24.16 mg/116g 41250-0235-41 Meijer 116 g — — Discontinued —
Calamine Plus Pramoxine HCl 5 mg/g; 75 mg/g; 10 mg/g 42507-0956-01 HY-VEE, 116 g — — FDA listed —
Calamine Plus .345 mg/mL; 2.72 mg/mL; 24.16 mg/mL 49035-0030-01 Wal-Mart 177 ml — — FDA listed —
Calamine Plus Pramoxine HCl 5 mg/g; 75 mg/g; 10 mg/g 56104-0100-10 Premier 116 g — — FDA listed —
Calamine Plus Pramoxine HCl .345 mg/116g; 24.16 mg/116g; 2.72 mg/116g 59779-0174-41 CVS 116 g — — FDA listed —
Calamine Plus Pramoxine HCl 5 mg/g; 75 mg/g; 10 mg/g 81522-0959-01 FSA 116 g — — FDA listed —
Calamine Plus Pramoxine HCl 5 mg/g; 75 mg/g; 10 mg/g 82442-0401-01 Target 116 g — — 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

🏛️
2023
On the market since
Jan 2023
📍
2026
Currently FDA-listed
3 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.

🔬 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 Plus (this brand).

Top reported reactions

Rash2
Application Site Irritation1
Bacterial Infection1
Chronic Obstructive Pulmonary Disease1
Discomfort1
Erythema1
Malignant Neoplasm Progression1

Reporter sex

4 reports
Male · 75%
Female · 25%

Serious outcomes

Death1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
46122-0745-31 You're viewing this 116 g in 1 CANISTER (46122-745-31) 2023-01-03 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 29 words ▾

Uses temporarily relieves pain and itching associated with: insect bites rashes minor skin irritations minor cuts dries the oozing and weeping of poison ivy, poison oak and poison sumac

⏱️ Dosage and Administration 49 words ▾

Directions shake well before using adults and children 2 years of age and older: apply as needed to the affected area, not more than 3 or 4 times daily cleanse the skin with soap and water let dry before use children under 2 years of age: consult a doctor

⚠️ Warnings 109 words ▾

​Warnings For external use only. ​Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure.

Do not store at temperatures above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal. ​When using this product do not get into eyes ask a doctor before using on children under 2 years of age Stop use and ask a doctor if conditions worsens symtomps last more than 7 days or clear up and occur again in a few days ​Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 7 words ▾

Active ingredient Calamine 8% Pramoxine HCl 1%

🧪 Inactive Ingredients 18 words ▾

​Inactive ingredients benzyl alcohol, camphor, disteardimonium hectorite, fragrance, hydrated silica, isobutane, oleyl alcohol, SD alcohol 40-B, sorbitan trioleate

🎯 Purpose 5 words ▾

Purpose Skin protectant External analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 46122-0744-04 · AMERISOURCEBERGEN 46122-0747-06 · AMERISOURCE →
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.