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Rugby Caldyphen Clear pramoxine hydrochloride and zinc acetate lotion 10 mg/mL; 1 mg/mL Lotion, 177 mL — NDC 00536-1269-58 package photo

Rugby Caldyphen Clear pramoxine hydrochloride and zinc acetate lotion 10 mg/mL; 1 mg/mL Lotion, 177 mL

by Rugby Laboratories · 177 mL in 1 CONTAINER (0536-1269-58)
NDC 00536-1269-58
🏷️ FDA NDC (as labeled) 0536-1269-58 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) 0536-1269-58
Product NDC 0536-1269
11-digit billing NDC 00536126958
NCPDP billing unit ML — per mL (volume)
RxCUI 1234546
UNII 88AYB867L5, FM5526K07A
Application # M016
SPL Set ID 9af3a740-ef97-26ce-e053-2a95a90a0ee1
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 2019-12-30
Marketing end 2027-09-30
Route TOPICAL
Dosage form LOTION
Substance PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
GPI-14 90859902954120
GPI class Caldyphen Clear
GCN Seq No 035594
GCN 96616
HICL code 013244
Ingredient (HICL) Pramoxine Hcl/Zinc Acetate
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 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 0536-1269-58 — 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 → 00536-1269-58. 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.

🏷️ RxNorm drug class

This medicine belongs to the Local anesthetics class.

Drug family (ATC) Local anesthetics, Anesthetics for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerRugby Laboratories
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedDec 2019
Product typeHuman Otc Drug
Portfolio149 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 CALDYPHEN CLEAR LOTION Ingredient Pramoxine Hcl/Zinc Acetate
🧪 What is this product?

Rugby Caldyphen Clear is an over-the-counter lotion applied to the skin. It contains pramoxine hydrochloride, a topical anesthetic that is typically used to numb minor skin irritation and itching, and zinc acetate, which is commonly included in skin-care products for its astringent properties. This product is marketed as an OTC 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.

🧪 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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.

10 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 Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, 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 $0.013 $2.35 / 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 Sep 2022 Jan 2026 Aug 2026 $0.014 $0.013
▼ Down 3% over the last 20 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rugby Caldyphen Clear 10 mg/mL; 1 mg/mLthis 00536-1269-58 Rugby 177 ml $0.013 — Availability likely —
Caldyphen Clear 10 mg/mL; 1 mg/mL 24385-0439-30 Amerisource 177 ml $0.013 — Availability likely —
Calamine Clear 10 mg/mL; 1 mg/mL 70000-0397-01 Cardinal 177 ml $0.013 — Availability likely —
Clear Anti-Itch 10 mg/mL; 1 mg/mL 83324-0245-06 Chain 177 ml $0.013 — Availability likely —
Sunmark Caldyphen Clear 80 mg/mL; 10 mg/mL 49348-0610-36 Strategic 177 ml $0.015 — FDA listed +14%
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 —
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

🏛️
2019
On the market since
Dec 2019
📍
2026
Currently FDA-listed
7 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00536-1269-58 You're viewing this 177 mL in 1 CONTAINER (0536-1269-58) 2019-12-30 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 24 words ▾

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

⏱️ Dosage and Administration 60 words ▾

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

⚠️ Warnings 83 words ▾

For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.

Ask a doctor before using on children under 2 years of age. When using this product. Discontinue use if condition worsens, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few days. and consult a doctor.

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

🧪 Active Ingredient 6 words ▾

Pramoxine HCl 1% Zing Acetate 0.1%

🧪 Inactive Ingredients 19 words ▾

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water.

🎯 Purpose 4 words ▾

External Analgesic Skin Protectant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00536-1268-12 · RUGBY 00536-1271-80 · Rugby →
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.