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Calamine Plus FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC .345 mg/mL; 2.72 mg/mL; 24.16 mg/mL Aerosol, Spray, 177 mL — NDC 49035-0030-01 package photo

Calamine Plus FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC .345 mg/mL; 2.72 mg/mL; 24.16 mg/mL Aerosol, Spray, 177 mL

by Wal-Mart Stores, Inc. · 177 mL in 1 CANISTER (49035-030-01)
NDC 49035-0030-01
🏷️ FDA NDC (as labeled) 49035-030-01 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 →

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) 49035-030-01
Product NDC 49035-030
11-digit billing NDC 49035003001
RxCUI 1544717
UNII 1K09F3G675, 88AYB867L5, SOI2LOH54Z
UPC 0681131052894
Application # M017
SPL Set ID eba4b13f-bc23-45d5-b01e-8ca10cdbb2cc
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-03-03
Marketing end 2026-09-30
Route TOPICAL
Dosage form AEROSOL, SPRAY
Substance FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 49035-030-01 — 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 → 49035-0030-01. 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.

🏭 Manufacturer & labeler

LabelerWal-Mart Stores, Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code49035
First marketedMar 2013
Product typeHuman Otc Drug
Portfolio83 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

🧪 What is this product?

Calamine Plus is a topical aerosol spray sold over the counter under FDA's OTC monograph rules. It contains pramoxine hydrochloride, a local anesthetic typically used to reduce itching and minor pain on skin, along with zinc oxide and ferric oxide red, which are commonly used in skin-care products for their protective and soothing properties. This product is meant for spraying onto affected skin areas to help relieve discomfort from minor irritation, itching, or similar conditions.

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 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 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.

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

The official label also statesInactive ingredients benzyl 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 mLPer 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Calamine Plus .345 mg/116g; 24.16 mg/116g; 2.72 mg/116g 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/mLthis 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

🏛️
2013
On the market since
Mar 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.

🔬 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
49035-0030-01 You're viewing this 177 mL in 1 CANISTER (49035-030-01) 2013-03-03 Active

🧭 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 FDA registers it as 49035-030-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 49035-0030-01, written without dashes as 49035003001. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 49035-0030-01, the first segment (49035) is the labeler code FDA assigned to Wal-Mart Stores, Inc.; the middle segment (0030) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but Wal-Mart Stores, Inc. has reported a marketing end date of 2026-09-30, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Wal-Mart Stores, 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.

📄 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 30 words ▾

Uses 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 42 words ▾

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

⚠️ Warnings 23 words ▾

Warnings Warnings For external use only. Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

🧪 Active Ingredient 7 words ▾

Active Ingredients Calamine 8% Pramoxine HCL 1%

🧪 Inactive Ingredients 20 words ▾

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

🎯 Purpose 6 words ▾

Purpose 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 ↗
← 49035-0029-29 · Wal-Mart 49035-0035-16 · EQUATE →
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.