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Sunmark Caldiphen Calamine and Pramoxine Hydrochloride 80 mg/mL; 10 mg/mL Lotion, 177 mL — NDC 49348-0337-36 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sunmark Caldiphen Calamine and Pramoxine Hydrochloride 80 mg/mL; 10 mg/mL Lotion, 177 mL — NDC 49348-337-36 (Billing 49348-0337-36)

by Strategic Sourcing Services · 177 mL in 1 BOTTLE, PLASTIC

This is a package of 177 mL of Sunmark Caldiphen Calamine and Pramoxine Hydrochloride 80 mg/mL; 10 mg/mL Lotion from Strategic Sourcing Services, marketed since Mar 1998 and currently FDA-listed; retail pharmacies pay about $0.0139 per mL (NADAC). It is this product's only package size.

NDC 49348-0337-36
🏷️ FDA NDC (as labeled) 49348-337-36 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 49348-337-36 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
49348 labeler · 337 product · 36 package
Package marketed since
Apr 2, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
177 mL per package
Barcode (UPC)
0010939145338
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

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
Quick answers
  • GSN (GCN sequence number): 022061
  • GCN: 65328
  • GPI-14 (Medi-Span): 90859902934120
  • HICL (First Databank): 010079
  • AHFS class code: 84:08.00.00
  • RxCUI (RxNorm): 1234532
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.

Clinical

Label name SM CALDYPHEN LOTION Ingredient Pramoxine Hcl/Calamine
🧪 What is this product?

Sunmark Caldiphen is a topical lotion containing zinc oxide and pramoxine hydrochloride. Zinc oxide is typically used as a protective barrier and mild astringent on skin, while pramoxine hydrochloride is a local anesthetic commonly used to numb minor skin irritation and itching. This product is marketed as an over-the-counter monograph drug, meaning it follows established FDA guidelines for its category rather than undergoing individual product 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.

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 $0.014 $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
Dec 2021 Mar 2022 Oct 2022 Jan 2024 $0.014 $0.013
▲ 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
49348-0337-36 You're viewing this Main listing 177 mL in 1 BOTTLE, PLASTIC 2014-04-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 +20%
Leader Calamine Plus 80 mg/mL; 10 mg/mL 70000-0400-01 Cardinal 177 ml $0.017 — Availability likely +20%
Foster and Thrive Caldyphen 80 mg/mL; 10 mg/mL 70677-1198-01 Strategic 177 ml $0.017 — Availability likely +20%
Calamine 80 mg/mL; 10 mg/mL 83324-0053-06 Chain 177 ml $0.017 — Availability likely +20%
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.

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.

Manufacturer & labeler

LabelerStrategic Sourcing Services
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code49348
First marketedMar 1998
Product typeHuman Otc Drug
Portfolio23 products on file

More NDCs from Strategic Sourcing Services labeler code 49348

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.

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 📄 Ask a Doctor Before Use If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 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

📄 Ask a Doctor Before Use If 25 words ▾

Stop ue and ask a doctor if condition worsens. Symptoms last for more than 7days or clear up and occur again whitin a few days.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center immediately.

📄 Other Information 8 words ▾

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

📄 Package Label / Principal Display Panel 5 words ▾

Principal Display Panel Label Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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.
← 49348-0274-72 · Strategic 49348-0379-54 · 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.