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Sunmark Phenolated Calamine Calamine and Zinc Oxide and Phenol 160 mg/mL; 10 mg/mL Lotion, 177 mL — NDC 49348-0802-34 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sunmark Phenolated Calamine Calamine and Zinc Oxide and Phenol 160 mg/mL; 10 mg/mL Lotion, 177 mL — NDC 49348-802-34 (Billing 49348-0802-34)

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

This is a package of 177 mL of Sunmark Phenolated Calamine Calamine and Zinc Oxide and Phenol 160 mg/mL; 10 mg/mL Lotion from Strategic Sourcing Services LLC, marketed since Mar 1998 and currently FDA-listed. It is this product's only package size.

NDC 49348-0802-34
🏷️ FDA NDC (as labeled) 49348-802-34 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49348-802-34
Product NDC 49348-802
11-digit billing NDC 49348080234
NCPDP billing unit ML — per mL (volume)
RxCUI 991369
UNII SOI2LOH54Z, 339NCG44TV
UPC 0010939147332
Application # M016
SPL Set ID 8e68efc4-4c95-41c0-9fed-32297b1b2edc
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; PHENOL

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

GPI-14 90971010104100
GPI class SM Calamine Phenolated
GCN Seq No 005493
GCN 78190
HICL code 002306
Ingredient (HICL) Calamine/Phenol Liquid
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L3
Therapeutic class — intermediate (HIC2) Protectives
HIC3 code L3A
Therapeutic class — specific (HIC3) Protectives
AHFS code 84:24.04.00
AHFS class Basic Lotions And Liniments
FDB label name SM CALAMINE PHENOLATED LOTION
FDB brand name Calamine Phenolated
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 005493
  • GCN: 78190
  • GPI-14 (Medi-Span): 90971010104100
  • HICL (First Databank): 002306
  • AHFS class code: 84:24.04.00
  • RxCUI (RxNorm): 991369
Why two NDCs? The FDA registers this code as 49348-802-34 — 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 → 49348-0802-34. 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 CALAMINE PHENOLATED LOTION Ingredient Calamine/Phenol Liquid
🧪 What is this product?

Sunmark Phenolated Calamine is a topical lotion marketed as an over-the-counter monograph drug. It contains phenol and zinc oxide, ingredients typically used to help soothe and dry irritated skin. This type of product is commonly applied to areas of itching, minor skin irritation, or rashes to provide temporary relief and protect the affected skin.

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 gPer 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
49348-0802-34 You're viewing this Main listing 177 mL in 1 BOTTLE, PLASTIC 2017-12-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Calamine Phenolated Topical Suspension 160 mg/mL; 10 mg/mL 00395-0407-96 Humco 177 ml — — FDA listed —
Sunmark Phenolated Calamine 160 mg/mL; 10 mg/mLthis 49348-0802-34 Strategic 177 ml — — FDA listed —
Foster and Thrive Phenolated Calamine 160 mg/mL; 10 mg/mL 70677-1197-01 Strategic 177 ml — — FDA listed —
Calamine Phenolated Topical Suspension 160 mg/mL; 10 mg/mL 82645-0921-96 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

🏛️
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 A3N5ZCN45C
    Bentonite is a naturally occurring clay mineral used in medicines as a binder and absorbent. It helps hold tablet ingredients together and can absorb moisture or unwanted substances in the formulation.
  • UNII PF5DZW74VN
    Calcium hydroxide is a white powder made from limestone. It's used in medicines as a buffer to adjust acidity and as a disintegrant to help tablets break apart in the stomach.
  • 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 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.

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

The official label also statesBentonite Magma, Calcium Hydroxide, Glycerin, 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 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.

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 24 words ▾

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

⏱️ Dosage and Administration 56 words ▾

directions (Shake well before using) Adult and children 2 years of age and older: Cleanse the skin with soap and water and let dry before each use. Apply product to the affected area using cotton or soft cloth, as often as needed for comfort. Children under 2 years of age : Consult a doctor before use.

⚠️ Warnings 45 words ▾

Warnings For external use only . Use only as directed. Avoid contact with eyes and mucous membranes. Do not apply to large areas of the body or in large quantities, particularly over raw or blistered areas. If applied to fingers or toes do not bandage.

🧪 Active Ingredient 13 words ▾

Active Ingredient Calamine 8%

Active Ingredient Zinc Oxide 8%

Active Ingredient Liquefied Phenol

🧪 Inactive Ingredients 9 words ▾

Inactive Ingredients. Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water.

🎯 Purpose 9 words ▾

Purpose Skin Protectant

Purpose Skin Protectant

Purpose Topical Analgesic

📄 Ask a Doctor Before Use If 32 words ▾

Ask a doctor before using on children under 2 years of age. When using this product. Discontinue use if condition worsen or does not improve within 7 days and consult a doctor.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of accidental ingestion, seek professional 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 6 words ▾

Principal Display Panel Label image description

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 Zinc Oxide and Phenol — the ingredient across all brands.

Top reported reactions

Diabetes Mellitus1
Drug Reaction With Eosinophilia And Systemic Symptoms1
Drug-induced Liver Injury1
Gastroenteritis1
Hepatic Function Abnormal1
Herpes Zoster1
Injection Site Pruritus1

Age at onset

Adult3

Reporter sex

6 reports
Male · 60%
Female · 40%

Serious outcomes

Hospitalization3
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 3 0
Most recent year is provisional (FAERS lags ~3 months).
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.

About this NDC listing & data coverage

Over-the-counter (OTC) product
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 ✓ Available
Inactive ingredients (structured) ✓ 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.
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.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Strategic Sourcing Services LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Strategic Sourcing Services LLC 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.
← 49348-0793-76 · Strategic 49348-0833-61 · 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.