🆔 Identity & classification

FDA NDC (as labeled) 49348-337-36

Product NDC 49348-337

11-digit billing NDC 49348033736

NCPDP billing unit ML — per mL (volume)

RxCUI 1234532

UNII SOI2LOH54Z, 88AYB867L5

UPC 0010939145338

Application # M016

SPL Set ID 4f4d4c54-64b5-4e20-bed0-c7fb470b8434

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 1998-03-25

Route TOPICAL

Dosage form LOTION

Substance ZINC OXIDE; PRAMOXINE HYDROCHLORIDE

GPI-14 90859902934120

GPI class SM Caldyphen

GCN Seq No 022061

GCN 65328

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 SM CALDYPHEN LOTION

FDB brand name Caldyphen

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 49348-337-36 — 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 → 49348-0337-36. 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

LabelerStrategic Sourcing Services

FDA applicationM016 (OTC MONOGRAPH DRUG)

Labeler code49348

First marketedMar 1998

Product typeHuman Otc Drug

Portfolio23 products on file

🔎 All NDCs from Strategic Sourcing Services

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 SM CALDYPHEN LOTION Ingredient Pramoxine Hcl/Calamine

🧪 What is this product?

Sunmark Caldiphen is a topical lotion sold as an over-the-counter monograph product. It contains pramoxine hydrochloride, a local anesthetic commonly used to numb skin temporarily, and zinc oxide, which is often used in topical products for its protective and soothing properties. This lotion is typically applied directly to affected skin areas to help relieve itching and minor skin irritation.

Patient education

📘 MedlinePlus patient leaflet ↗

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 N20HL7Q941
Camphor is a waxy, aromatic substance derived from camphor tree wood or made synthetically. In medicines, it typically serves as a preservative, flavoring agent, or mild skin irritant in topical products.
UNII H5RIZ3MPW4
A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
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 A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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.

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

The official label also statesSD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methycelulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben and 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 system	Per mL	Per package
Retail pharmacies payNADAC · weekly	$0.014	$2.46 / 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

▲ Up 5% over the last 10 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Sunmark Caldiphen 80 mg/mL; 10 mg/mLthis 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	+22%
Leader Calamine Plus 80 mg/mL; 10 mg/mL 70000-0400-01	Cardinal	177 ml	$0.017	—	Availability likely	+22%
Foster and Thrive Caldyphen 80 mg/mL; 10 mg/mL 70677-1198-01	Strategic	177 ml	$0.017	—	Availability likely	+22%
Calamine 80 mg/mL; 10 mg/mL 83324-0053-06	Chain	177 ml	$0.017	—	Availability likely	+22%
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/mL 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	—
Quality Choice Anti-itch Medicated 80 mg/mL; 10 mg/mL 63868-0420-96	CHAIN	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

🏛️

1998

On the market since

Mar 1998

📍

2026

Currently FDA-listed

28 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

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 NDC	Description	Marketing start	Status
49348-0337-36 You're viewing this	177 mL in 1 BOTTLE, PLASTIC (49348-337-36)	2014-04-02	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 22 words ▾

Uses Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other skin irritations.

⏱️ Dosage and Administration 57 words ▾

Directions Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort. Children under 2 yrs. of age. Consult a doctor before use.

⚠️ Warnings 20 words ▾

Warnings For external use only. Use only as directed. When using this product. Avoid contact with eyes and moucous membranes.

🧪 Active Ingredient 7 words ▾

Active Ingredients Calamine 8% Pramoxine HCl 1%

🧪 Inactive Ingredients 22 words ▾

Inactive Ingredients SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methycelulose, 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 ↗

🔗 Related NDC lookups

🧪 All Calamine And Pramoxine Hydrochloride NDCsSame ingredient 🏭 All Strategic labeler NDCsLabeler code 49348 📚 All Copper Absorption Inhibitor NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Antipruritics,Topical.

Doxepin Hcl 00093-9609-95 Diphenhydramine Hcl/Zinc Acet 00113-0622-64 Pramoxine Hcl/Zinc Acetate 00187-5466-06 Pramoxine Hcl/Benzyl Alcohol 00225-0495-33 Pramoxine Hcl/Menthol 00316-0234-12 Pramoxine Hcl/Camph/Zinc Acet 00395-0400-96 Pramoxine Hcl/Diphenhydramine 11383-0192-01 Diphenhydramine Hcl 37205-0338-16 Pramoxine/Zinc Oxide/Calamine 54859-0120-04

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

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

🆔 Identity & classification

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🔬 Reported adverse events (FAERS)

Top reported reactions

Reporter sex

📦 Packaging — all sizes for this product

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups

💊 Related drugs in this class