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Sunmark Caldyphen Clear Zinc Acetate and Pramoxine Hydrochloride 80 mg/mL; 10 mg/mL Lotion, 177 mL — NDC 49348-0610-36 package photo

Sunmark Caldyphen Clear Zinc Acetate and Pramoxine Hydrochloride 80 mg/mL; 10 mg/mL Lotion, 177 mL

by Strategic Sourcing Services LLC · 177 mL in 1 BOTTLE, PLASTIC (49348-610-36)
NDC 49348-0610-36
🏷️ FDA NDC (as labeled) 49348-610-36 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) 49348-610-36
Product NDC 49348-610
11-digit billing NDC 49348061036
NCPDP billing unit ML — per mL (volume)
UNII SOI2LOH54Z, 88AYB867L5
UPC 0010939146335
Application # M016
SPL Set ID 329cd4ef-b699-46ff-a5d6-907f7c327c03
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 90859902954120
GPI class SM Caldyphen Clear
GCN Seq No 022347
GCN 82940
HICL code 009173
Ingredient (HICL) Pramoxine Hcl/Camph/Zinc Acet
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 CLEAR LOTION
FDB brand name Caldyphen Clear
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 49348-610-36 — 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 → 49348-0610-36. 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 LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code49348
First marketedMar 1998
Product typeHuman Otc Drug
Portfolio316 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 SM CALDYPHEN CLEAR LOTION Ingredient Pramoxine Hcl/Camph/Zinc Acet
🧪 What is this product?

Sunmark Caldyphen Clear is an over-the-counter lotion applied to the skin to help relieve minor itching, burning, and discomfort. It contains pramoxine hydrochloride, a topical numbing agent that reduces skin sensation, and zinc oxide, which is commonly used in skin-care products for its protective and soothing properties. This is an OTC monograph product, meaning it is made according to FDA category rules rather than as an individually approved drug application.

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 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.

9 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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.015 $2.67 / 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
Jul 2021 $0.015 $0.015
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
Rugby Caldyphen Clear 10 mg/mL; 1 mg/mL 00536-1269-58 Rugby 177 ml $0.013 — Availability likely save 13%
Caldyphen Clear 10 mg/mL; 1 mg/mL 24385-0439-30 Amerisource 177 ml $0.013 — Availability likely save 13%
Calamine Clear 10 mg/mL; 1 mg/mL 70000-0397-01 Cardinal 177 ml $0.013 — Availability likely save 13%
Clear Anti-Itch 10 mg/mL; 1 mg/mL 83324-0245-06 Chain 177 ml $0.013 — Availability likely save 13%
Sunmark Caldyphen Clear 80 mg/mL; 10 mg/mLthis 49348-0610-36 Strategic 177 ml $0.015 — FDA listed —
Caladryl Clear 10 mg/mL; 1 mg/mL 00187-5466-06 Bausch 177 ml — — FDA listed —
calahist clear 10 mg/mL; 1 mg/mL 00363-9412-97 WALGREEN 177 ml — — FDA listed —
Humco Calaclear 10 mg/mL; 1 mg/mL 00395-0400-96 Humco 177 ml — — FDA listed —
Clear Anti-Itch 10 mg/mL; 1 mg/mL 11344-0812-30 Nice-Pak 177 ml — — FDA listed —
Clear Anti Itch 10 mg/mL; 1 mg/mL 21130-0952-30 Better 177 ml — — FDA listed —
Clear Anti Itch 10 mg/mL; 1 mg/mL 36800-0218-30 Topco 177 ml — — FDA listed —
TopCare Calaclear 10 mg/mL; 1 mg/mL 36800-0267-96 TOPCO 177 ml — — FDA listed —
Clear Anti Itch 10 mg/mL; 1 mg/mL 41163-0099-30 United 177 ml — — FDA listed —
Clear Anti-Itch 10 mg/mL; 1 mg/mL 41250-0218-30 Meijer, 177 ml — — FDA listed —
Calaclear 10 mg/mL; 1 mg/mL 49035-0402-96 Wal-Mart 177 ml — — FDA listed —
Clear Anti-Itch 10 mg/mL; 1 mg/mL 55910-0218-30 Old 177 ml — — FDA listed —
Clear Anti Itch 10 mg/mL; 1 mg/mL 59640-0218-30 H 177 ml — — FDA listed —
Quality Choice Anti-Itch Clear 80 mg/mL; 10 mg/mL 63868-0097-06 Chain 177 ml — — FDA listed —
CVS Itch Relief 10 mg/mL; 1 mg/mL 69842-0400-96 CVS 177 ml — — FDA listed —
Foster and Thrive Caldyphen Clear 10 mg/mL; 1 mg/mL 70677-1199-01 Strategic 177 ml — — FDA listed —
Clear Anti-Itch 10 mg/mL; 1 mg/mL 72476-0218-30 Retail 177 ml — — FDA listed —
Clear Anti-Itch 10 mg/mL; 1 mg/mL 75981-0218-30 Perrigo 177 ml — — FDA listed —
Calamine Clear 10 mg/mL; 1 mg/mL 82645-0400-96 Pharma 177 ml — — FDA listed —
Calaclear 10 mg/mL; 1 mg/mL 82645-0923-96 Pharma 177 ml — — FDA listed —
HEB Calaclear 80 mg/mL; 10 mg/mL 37808-0040-96 H 177 ml — — FDA listed —
HEB Calagesic 80 mg/mL; 10 mg/mL 37808-0968-96 H 177 ml — — FDA listed —
Publix Clear Anti-Itch 80 mg/mL; 10 mg/mL 41415-0400-96 Publix 177 ml — — FDA listed —
Publix Calamine Medicated 80 mg/mL; 10 mg/mL 41415-0420-96 Publix 177 ml — — FDA listed —
DDM Calaclear 80 mg/mL; 10 mg/mL 53943-0400-96 Discount 177 ml — — FDA listed —
DDM Calagesic 80 mg/mL; 10 mg/mL 53943-0420-96 Discount 177 ml — — FDA listed —
Best Choice Anti-Itch Clear 80 mg/mL; 10 mg/mL 63941-0400-96 Valu 177 ml — — FDA listed —
Best Choice Medicated Calamine 80 mg/mL; 10 mg/mL 63941-0420-96 Valu 177 ml — — FDA listed —
Premier Value Calaclear 80 mg/mL; 10 mg/mL 68016-0400-96 Chain 177 ml — — FDA listed —
Harris Teetter Calagesic 80 mg/mL; 10 mg/mL 69256-0400-96 Harris 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 Zinc Acetate and Pramoxine Hydrochloride — the ingredient across all brands.

Top reported reactions

Adverse Reaction1
Anaphylactic Reaction1
Condition Aggravated1
Dermatitis Contact1
Hypersensitivity1

Reporter sex

3 reports
Female · 100%

Serious outcomes

Hospitalization1
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
49348-0610-36 You're viewing this 177 mL in 1 BOTTLE, PLASTIC (49348-610-36) 2017-12-12 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 31 words ▾

Warnings For external use only. Use only as directed. When using this product. Avoid contact with eyes and moucous membranes. Ask a doctor before using on children 2 years of age.

🧪 Active Ingredient 8 words ▾

Active Ingredients Zinc Acetate 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 ↗
← 49348-0600-72 · Strategic 49348-0622-37 · Strategic →
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.