Home › NDC Lookup › Ingredients › Pramoxine Hcl, Zinc Oxide, Calamine › 54859-0120-04
🧴image loading
(from DailyMed)

Dermagesic Pramoxine HCl, Zinc Oxide, Calamine .4 mg/100mL; 1 mg/100mL; .4 mg/100mL Liquid, 118 mL — NDC 54859-120-04 (Billing 54859-0120-04)

by Llorens Pharmaceuticals International Division · 118 mL in 1 BOTTLE

This is a package of 118 mL of Dermagesic Pramoxine HCl, Zinc Oxide, Calamine .4 mg/100mL; 1 mg/100mL; .4 mg/100mL Liquid from Llorens Pharmaceuticals International Division, no longer marketed (first marketed Jan 2014), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 54859-0120-04
🏷️ FDA NDC (as labeled) 54859-120-04 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54859-120-04
Product NDC 54859-120
11-digit billing NDC 54859012004
NCPDP billing unit ML — per mL (volume)
UNII 88AYB867L5, SOI2LOH54Z, 1K09F3G675
Application # M016
SPL Set ID 8b3f8894-1ed7-4888-a42c-8510d6161edd
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2014-01-01
Route TOPICAL
Dosage form LIQUID
Substance PRAMOXINE HYDROCHLORIDE; ZINC OXIDE; FERRIC OXIDE RED

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

GPI-14 90859903970920
GPI class Dermagesic
GCN Seq No 076346
GCN 41815
HICL code 043598
Ingredient (HICL) Pramoxine/Zinc Oxide/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 DERMAGESIC LOTION
FDB brand name Dermagesic
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 076346
  • GCN: 41815
  • GPI-14 (Medi-Span): 90859903970920
  • HICL (First Databank): 043598
  • AHFS class code: 84:08.00.00
Why two NDCs? The FDA registers this code as 54859-120-04 — 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 → 54859-0120-04. 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 DERMAGESIC LOTION Ingredient Pramoxine/Zinc Oxide/Calamine
🧪 What is this product?

Dermagesic is a topical liquid sold as an over-the-counter monograph product. It contains pramoxine hydrochloride, a local anesthetic typically used to numb minor skin irritation, along with zinc oxide and calamine, which are commonly used in skin protectant and soothing products. Ferric oxide red is included as a colorant. This type of product is generally intended for minor topical discomfort, though the specific indications depend on how it is labeled and marketed.

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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
54859-0120-04 You're viewing this Main listing 118 mL in 1 BOTTLE 2014-01-01 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dermagesic .4 mg/100mL; 1 mg/100mL; .4 mg/100mLthis 54859-0120-04 Llorens 118 ml — — Discontinued —
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

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 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.

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.

Manufacturer & labeler

LabelerLlorens Pharmaceuticals International Division
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code54859
First marketedJan 2014
Product typeHuman Otc Drug
Portfolio11 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.

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 📄 Do Not Use 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 35 words ▾

Uses for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor irritations dries the oozing and weeping of poison ivy, poison oak and poison sumac.

⏱️ Dosage and Administration 40 words ▾

Directions SHAKE WELL Adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily Children under 2 years of age ask a doctor Do not use more often than directed

⚠️ Warnings 18 words ▾

Warnings For external use only. Avoid contact with the eyes Not for Pediatric use Hypersensitivity to "caine" anesthetics

🧪 Active Ingredient 20 words ▾

Active Ingredients Purpose Pramozine HCl .... 1% ............ Anesthetic/Analgesic Zinc Oxide .........0.4% ............ Skin Protectant Calamine ...........0.4% ............ Skin Protectant

🧪 Inactive Ingredients 29 words ▾

Inactive Ingredients: Glycerin, glyceryl stearate, PEG-100 Stearate, cetearyl alcohol, methylparaben, propylparaben, aloe barbadensis leaf juic (aloe vera), avena sativa (oat) kernel colloidal oatmeal, fregrance, hydroxypropyl methylcellulose, menthol, purified water

🎯 Purpose 4 words ▾

Purpose Anesthetic/Analgesic Skin Protectant

📄 Do Not Use 63 words ▾

Do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth Ask a doctor before use on chicken pox on measles Stop use and ask a doctor if condition worsens or does not improve within 7 days symptoms persist for more than 7 days or clear up and occur again within a few days

📄 Keep Out of Reach of Children 19 words ▾

KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 2 words ▾

Questions: 1-866-595-5598

📄 Package Label / Principal Display Panel 1 words ▾

DermagesicLabel

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

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
Llorens Pharmaceuticals International Division 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.
← 54859-0011-04 · Llorens 54859-0202-04 · Llorens →
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.