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calahist Calamine and Pramoxine Hydrochloride 10 mg/mL; 80 mg/mL Lotion, 177 mL

by WALGREEN COMPANY · 177 mL in 1 BOTTLE (0363-9411-97)
NDC 00363-9411-97
🏷️ FDA NDC (as labeled) 0363-9411-97 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) 0363-9411-97
Product NDC 0363-9411
11-digit billing NDC 00363941197
RxCUI 1234532
UNII 88AYB867L5, SOI2LOH54Z
Application # M016
SPL Set ID fed45e06-cc53-fbc5-e053-6294a90a1b19
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-16
Route TOPICAL
Dosage form LOTION
Substance PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 0363-9411-97 — 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 → 00363-9411-97. 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

LabelerWALGREEN COMPANY
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code00363
First marketedOct 2023
Product typeHuman Otc Drug
Portfolio468 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?

Calahist is a lotion applied to the skin. It contains pramoxine hydrochloride, a local anesthetic typically used to numb minor skin irritation and itching, and zinc oxide, which is commonly used in topical products for its soothing and protective properties. This is an over-the-counter monograph product, meaning it follows FDA's established rules for its product category rather than an individual drug review.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 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
Sunmark Caldiphen 80 mg/mL; 10 mg/mL 49348-0337-36 Strategic 177 ml $0.014 — FDA listed —
GNP Caldyphen 80 mg/mL; 10 mg/mL 24385-0072-82 Amerisource 177 ml $0.017 — Availability likely —
Leader Calamine Plus 80 mg/mL; 10 mg/mL 70000-0400-01 Cardinal 177 ml $0.017 — Availability likely —
Foster and Thrive Caldyphen 80 mg/mL; 10 mg/mL 70677-1198-01 Strategic 177 ml $0.017 — Availability likely —
Calamine 80 mg/mL; 10 mg/mL 83324-0053-06 Chain 177 ml $0.017 — Availability likely —
Caladryl 1.36 mg/mL; 78.65 mg/mL; 10 mg/mL 00187-5465-06 Bausch 177 ml — — FDA listed —
calahist 10 mg/mL; 80 mg/mLthis 00363-9411-97 WALGREEN 177 ml — — FDA listed —
Humco Calagesic 80 mg/mL; 10 mg/mL 00395-0420-96 Humco 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 11344-0136-30 Nice-Pak 177 ml — — FDA listed —
TopCare Calagesic 80 mg/mL; 10 mg/mL 36800-0268-96 TOPCO 177 ml — — FDA listed —
Calamine, Pramoxind HCl 80 mg/mL; 10 mg/mL 37808-0616-30 H 177 ml — — FDA listed —
HEB Calagesic 80 mg/mL; 10 mg/mL 37808-0968-96 H 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 41163-0536-30 United 177 ml — — FDA listed —
Publix Calamine Medicated 80 mg/mL; 10 mg/mL 41415-0420-96 Publix 177 ml — — FDA listed —
Best Choice Medicated Calamine 80 mg/mL; 10 mg/mL 63941-0420-96 Valu 177 ml — — FDA listed —
CVS Calamine Plus 80 mg/mL; 10 mg/mL 69842-0420-96 CVS 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 72288-0436-30 Amazon.com 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 75981-0336-30 Perrigo 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 76162-0336-30 Topco 177 ml — — FDA listed —
Calamine 80 mg/mL; 10 mg/mL 79481-0336-01 Meijer, 177 ml — — FDA listed —
Freskaro Calamine Plus 80 mg/mL; 10 mg/mL 82645-0420-96 Pharma 177 ml — — FDA listed —
Humco Calagesic 80 mg/mL; 10 mg/mL 82645-0922-96 Pharma 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

🏛️
2023
On the market since
Oct 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 and Pramoxine Hydrochloride — the ingredient across all brands.

Top reported reactions

Dermatitis Contact1
Product Quality Issue1

Reporter sex

1 reports
Male · 100%
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
00363-9411-97 You're viewing this 177 mL in 1 BOTTLE (0363-9411-97) 2023-10-16 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 0363-9411-97, 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: 00363-9411-97, written without dashes as 00363941197. 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 00363-9411-97, the first segment (00363) is the labeler code FDA assigned to WALGREEN COMPANY; the middle segment (9411) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (97) 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: this package is listed as actively marketed, with no marketing end date reported by WALGREEN COMPANY. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
WALGREEN COMPANY 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 54 words ▾

Uses ■ Dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac ■ For the temporary relief of pain and itching associated with ■ minor skin irritations ■ rashes due to poison ivy, poison oak, or poison sumac ■ minor burns ■ sunburn ■ minor cuts ■ scrapes ■ insect bites

⏱️ Dosage and Administration 60 words ▾

Directions ■ shake well before using ■ cleanse the skin with soap and water ■ let dry before each use ■ apply lotion to the affected area using cotton or soft cloth adults and children 2 years and older Not more than 3 to 4 times daily as needed for comfort children under 2 years Consult a doctor before use

⚠️ Warnings 11 words ▾

Warnings ■ For external use only ■ Use only as directed.

📦 Storage and Handling 11 words ▾

Other information Store at room temperature 15°- 30°C (59° - 86°F)

🧪 Active Ingredient 7 words ▾

Active ingredient Calamine 8% Pramoxine HCI 1%

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients SD alcohol 38B 2.5%, camphor, diazolidinyl urea, fragrances, glycerin, hydroxypropyl methylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben and purified water

🎯 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 ↗
← 00363-9410-97 · WALGREEN 00363-9412-97 · WALGREEN →
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.