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Humco Calaclear Pramoxine Hydrochloride and Zinc Acetate 10 mg/mL; 1 mg/mL Lotion, 177 mL — NDC 00395-0400-96 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Humco Calaclear Pramoxine Hydrochloride and Zinc Acetate 10 mg/mL; 1 mg/mL Lotion, 177 mL — NDC 0395-0400-96 (Billing 00395-0400-96)

by Humco Holding Group, Inc. · 177 mL in 1 BOTTLE, PLASTIC

This is a package of 177 mL of Humco Calaclear Pramoxine Hydrochloride and Zinc Acetate 10 mg/mL; 1 mg/mL Lotion from Humco Holding Group, Inc., marketed since Mar 1998 and currently FDA-listed. It is this product's only package size.

NDC 00395-0400-96
🏷️ FDA NDC (as labeled) 0395-0400-96 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 0395-0400-96 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0395 labeler · 0400 product · 96 package
Package marketed since
Mar 25, 1998
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
177 mL per package
Barcode (UPC)
0303950400969
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0395-0400-96
Product NDC 0395-0400
11-digit billing NDC 00395040096
NCPDP billing unit ML — per mL (volume)
RxCUI 1234546, 1248193
UNII 88AYB867L5, FM5526K07A
UPC 0303950400969
Application # M016
SPL Set ID 5fca3a73-6d66-496b-bd33-6e044f9039bc
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 PRAMOXINE HYDROCHLORIDE; ZINC ACETATE

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

GPI-14 90859902954120
GPI class Calaclear
GCN Seq No 022347
GCN 82940
HICL code 009173
Ingredient (HICL) Pramoxine Hcl/Camph/Zinc Acet
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 CALACLEAR LOTION
FDB brand name Calaclear
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 022347
  • GCN: 82940
  • GPI-14 (Medi-Span): 90859902954120
  • HICL (First Databank): 009173
  • AHFS class code: 84:08.00.00
  • RxCUI (RxNorm): 1234546
Why two NDCs? The FDA registers this code as 0395-0400-96 — 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 → 00395-0400-96. 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.

Clinical

Label name CALACLEAR LOTION Ingredient Pramoxine Hcl/Camph/Zinc Acet
🧪 What is this product?

Humco Calaclear is an over-the-counter lotion applied to the skin. It contains pramoxine hydrochloride, a local anesthetic typically used to numb minor skin irritation, and zinc acetate, a mineral salt commonly included in skin-care products for its astringent and soothing properties. This lotion is marketed under FDA's established rules for topical anti-itch and skin-protectant products.

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
00395-0400-96 You're viewing this Main listing 177 mL in 1 BOTTLE, PLASTIC 1998-03-25 — 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/mLthis 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

🏛️
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.

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

LabelerHumco Holding Group, Inc.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code00395
First marketedMar 1998
Product typeHuman Otc Drug
Portfolio35 products on file

More NDCs from Humco Holding Group, Inc. labeler code 00395

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 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 25 words ▾

Use 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 61 words ▾

Directions 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 85 words ▾

Warnings 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 10 words ▾

Active Ingredient Pramoxine HCl 1%

Active Ingredient Zinc Acetate 0.1%

🧪 Inactive Ingredients 21 words ▾

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

🎯 Purpose 6 words ▾

Purpose External Analgesic

Purpose Skin Protectant

📄 Ask a Doctor Before Use If 12 words ▾

Ask a doctor before using on children under 2 years of age.

📄 When Using This Product 36 words ▾

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 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 18 words ▾

Other Information store at room temperature 15 o – 30 o C (50 o – 85 o F)

📄 Package Label / Principal Display Panel 14 words ▾

Label Calaclear.jpg PRINCIPAL DISPLAY PANEL NDC 0395-0400-96 CALACLEARTM Lotion 6 FL OZ (177 mL)

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) — 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.
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 Humco Holding Group, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Humco Holding Group, Inc. 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.
← 00395-0247-92 · Humco 00395-0407-96 · Humco →
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.