Home › NDC Lookup › Ingredients › Pramoxine Hcl, Zinc Acetate › 11344-0812-30
Clear Anti-Itch Pramoxine HCl, Zinc acetate 10 mg/mL; 1 mg/mL Lotion, 177 mL — NDC 11344-0812-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clear Anti-Itch Pramoxine HCl, Zinc acetate 10 mg/mL; 1 mg/mL Lotion, 177 mL — NDC 11344-812-30 (Billing 11344-0812-30)

by Nice-Pak Products, LLC · 177 mL in 1 BOTTLE, PLASTIC

This is a package of 177 mL of Clear Anti-Itch Pramoxine HCl, Zinc acetate 10 mg/mL; 1 mg/mL Lotion from Nice-Pak Products, LLC, marketed since Jul 2024 and currently FDA-listed. It is this product's only package size.

NDC 11344-0812-30
🏷️ FDA NDC (as labeled) 11344-812-30 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 Oct 1, 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) 11344-812-30
Product NDC 11344-812
11-digit billing NDC 11344081230
Application # M016
SPL Set ID b5b810b8-97c0-4ed5-bd30-17dc01e08d61
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 2024-07-29
Route TOPICAL
Dosage form LOTION
Substance PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Why two NDCs? The FDA registers this code as 11344-812-30 — 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 → 11344-0812-30. 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

🧪 What is this product?

This is an over-the-counter topical lotion formulated under FDA's OTC monograph rules. It contains pramoxine hydrochloride, a local anesthetic, and zinc acetate, both commonly used to reduce itching and soothe irritated skin when applied directly to the affected area. The lotion is typically used for minor skin irritation, rashes, and itchy conditions.

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
11344-0812-30 You're viewing this Main listing 177 mL in 1 BOTTLE, PLASTIC 2024-07-29 — Active

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 —
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 —
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/mLthis 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

🏛️
2024
On the market since
Jul 2024
📍
2026
Currently FDA-listed
2 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 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 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII 5TJD82A1ET
    A cooling crystalline substance made synthetically that is added to medicines as a fragrance, flavoring agent, and mild local irritant to produce a cooling or warming sensation on the skin or mucous membranes.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII STI11B5A2X
    Polysorbate 40 is a synthetic emulsifier derived from sorbitol and fatty acids. It helps keep oils and water mixed together in liquid medications and also improves how the product flows.
  • UNII 8LGU7VM393
    Rosemary leaf oil is a natural aromatic oil extracted from rosemary plants. It's used in medicines as a flavoring agent and preservative to help protect the product from spoilage.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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.

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

The official label also statesalcohol, benzoic acid, camphor, citric acid, fragrance, glycerin, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, polysorbate 40, Rosmarinus officinalis (rosemary) leaf oil, sodium citrate, 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

LabelerNice-Pak Products, LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code11344
First marketedJul 2024
Product typeHuman Otc Drug
Portfolio45 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 🤒 Adverse Reactions 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 38 words ▾

Uses for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak or poison sumac dries the oozing and weeping of poison: - ivy - oak - sumac

⏱️ Dosage and Administration 40 words ▾

Directions shake well before applying wash affected area of skin 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 - ask a doctor

⚠️ Warnings 5 words ▾

Warnings For external use only

🤒 Adverse Reactions 13 words ▾

Adverse reaction Distributed by: Consumer Product Partners, LLC, St. Louis, MO 63114 1-888-593-0593

📦 Storage and Handling 9 words ▾

Other information store at room temperature (59° - 77°F)

🧪 Active Ingredient 8 words ▾

Active ingredients Pramoxine HCl 1% Zinc acetate 0.1%

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients alcohol, benzoic acid, camphor, citric acid, fragrance, glycerin, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, polysorbate 40, Rosmarinus officinalis (rosemary) leaf oil, sodium citrate, water

🎯 Purpose 5 words ▾

Purpose External analgesic Skin protectant

📄 When Using This Product 9 words ▾

When using this product do not get into eyes

📄 Stop Use and Ask a Doctor If 26 words ▾

Stop use section and ask a doctor if condition worsens symptoms last 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.

📄 Package Label / Principal Display Panel 49 words ▾

Principal Display Panel swan ® Clear Anti-Itch Lotion External Analgesic/Skin Protectant Drying action plus itch relief For relief from pain and itching due to: Poison Ivy Poison Suman Insect Bites Poison Oak Minor Skin Irritations Compare to Caladryl ® Clear ® Lotion* 6 FL OZ (177 mL) image description

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
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 Nice-Pak Products, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Nice-Pak Products, 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.
← 11344-0810-08 · Nice-Pak 11344-0822-43 · Nice-Pak →
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.