Humco Calamine Calamine 8% and Zinc Oxide 160 mg/mL Lotion, 177 mL
by Humco holding Group, Inc. · 177 mL in 1 BOTTLE, PLASTIC (0395-0413-96)
NDC 00395-0413-96
🏷️ FDA NDC (as labeled)
0395-0413-96
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 →
🆔 Identity & classification
FDA NDC (as labeled)
0395-0413-96
Product NDC
0395-0413
11-digit billing NDC
00395041396
NCPDP billing unit
ML — per mL (volume)
RxCUI
617954
UNII
SOI2LOH54Z
UPC
0303950413969
Application #
M016
SPL Set ID
f7dcd959-fb98-43bb-8dd3-a662bf8a053c
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
GPI-14
90979902204100
GPI class
Calamine-Zinc Oxide
GCN Seq No
061802
GCN
97587
HICL code
002304
Ingredient (HICL)
Calamine/Zinc Oxide
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
CALAMINE LOTION
FDB brand name
Calamine
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0395-0413-96 — 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 → 00395-0413-96. 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.
🏭 Manufacturer & labeler
LabelerHumco holding Group, Inc.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code00395
First marketedMar 1998
Product typeHuman Otc Drug
Portfolio35 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 CALAMINE LOTION Ingredient Calamine/Zinc Oxide
🧪 What is this product?
This is a topical lotion containing calamine and zinc oxide, marketed as an over-the-counter monograph product. Calamine and zinc oxide are typically used in lotions applied to the skin to help relieve itching and irritation from minor skin conditions such as insect bites, poison ivy, and eczema. The lotion is meant for external use on affected areas of skin.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Calamine 8% and Zinc Oxide 8%?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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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 5C69YCD2YJ
Carrageenan is a natural thickener and stabilizer extracted from red seaweed. It's used in medicines to create gel-like textures, improve consistency, and help keep ingredients from separating during storage.
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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.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
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.
-
UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
7 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesBentonite magma, calcium hydroxide, carrageenan, glycerin, microcrystalline cellulose, purified water, and xanthan gum.
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 system | Per g | Per 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Quality Choice Calamine 160 mg/mL 63868-0317-06 | Chain | 177 ml | $0.009 | — | FDA listed | — |
| Calamine 80 mg/mL; 80 mg/mL 00904-2533-21 | Major | 177 ml | $0.011 | — | Availability likely | — |
| GNP Calamine Topical Suspension 160 mg/mL 24385-0413-96 | Amerisource | 177 ml | $0.011 | — | Availability likely | — |
| Calamine 80 mg/100mL; 80 mg/100mL 46122-0809-29 | AMERISOURCE | 177 ml | $0.011 | — | Availability likely | — |
| Sunmark Calamine 160 mg/mL 49348-0011-34 | Strategic | 177 ml | $0.011 | — | Availability likely | — |
| Health Mart Calamine 160 mg/mL 62011-0114-01 | Strategic | 177 ml | $0.011 | — | Availability likely | — |
| Calamine 80 mg/mL; 80 mg/mL 70677-1196-01 | Strategic | 177 ml | $0.011 | — | Availability likely | — |
| calamine 160 mg/mL 70677-1316-01 | STRATEGIC | 177 ml | $0.011 | — | Availability likely | — |
| Calamine 80 mg/mL; 80 mg/mL 83324-0248-06 | Chain | 177 ml | $0.011 | — | Availability likely | — |
| calamine 160 mg/mL 00363-9410-97 | WALGREEN | 177 ml | — | — | FDA listed | — |
| Humco Calamine 160 mg/mLthis 00395-0413-96 | Humco | 177 ml | — | — | FDA listed | — |
| Calamine 80 mg/mL; 80 mg/mL 11344-0063-30 | Nice-Pak | 177 ml | — | — | FDA listed | — |
| Calamine 80 mg/mL; 80 mg/mL 11673-0063-30 | Target | 177 ml | — | — | FDA listed | — |
| Rite Aid Calamine 160 mg/mL 11822-4352-09 | Rite | 177 ml | — | — | FDA listed | — |
| Calamine 80 mg/mL; 80 mg/mL 21130-0941-30 | Better | 177 ml | — | — | FDA listed | — |
| Calamine 8 g/mL; 8 g/mL 30142-0063-30 | The | 177 ml | — | — | FDA listed | — |
| Assured Calamine 160 mg/mL 33992-4130-06 | Greenbriar | 177 ml | — | — | FDA listed | — |
| Calamine 80 mg/mL; 80 mg/mL 36800-0063-30 | Topco | 177 ml | — | — | FDA listed | — |
| TopCare Calamine 160 mg/mL 36800-0702-96 | TOPCO | 177 ml | — | — | FDA listed | — |
| Calamine, Zinc Oxide 80 mg/mL; 80 mg/mL 37808-0621-30 | H | 177 ml | — | — | FDA listed | — |
| Calamine 160 mg/mL 49035-0413-96 | Wal-Mart | 177 ml | — | — | FDA listed | — |
| DDM Calamine 160 mg/mL 53943-0413-96 | Discount | 177 ml | — | — | FDA listed | — |
| Calamine 80 mg/mL; 80 mg/mL 55301-0063-30 | Your | 177 ml | — | — | FDA listed | — |
| Calamine 80 mg/mL; 80 mg/mL 55319-0063-30 | Family | 177 ml | — | — | FDA listed | — |
| Calamine 80 mg/mL; 80 mg/mL 55910-0063-30 | Old | 177 ml | — | — | FDA listed | — |
| Health Care Calamine 160 mg/mL 64092-0413-96 | Great | 177 ml | — | — | FDA listed | — |
| Premiere Value Calamine 160 mg/mL 68016-0413-96 | Chain | 177 ml | — | — | FDA listed | — |
| Calamine 8 g/mL; 8 mg/mL 68071-4322-06 | NuCare | 177 ml | — | — | FDA listed | — |
| Calamine 8 g/mL; 8 mg/mL 68788-0292-01 | Preferred | 177 ml | — | — | FDA listed | — |
| Harris Teeter Calamine 160 mg/mL 69256-0413-96 | Harris | 177 ml | — | — | FDA listed | — |
| Calamine 80 mg/mL; 80 mg/mL 72476-0063-30 | Retail | 177 ml | — | — | FDA listed | — |
| Calamine 8 mg/mL; 8 mg/mL 75981-0063-30 | Perrigo | 177 ml | — | — | FDA listed | — |
| RID Poison Ivy Rash Relief 80 mg/mL; 80 mg/mL 82392-0300-01 | Oystershell | 177 ml | — | — | FDA listed | — |
| Calamine 80 mg/mL; 80 mg/mL 82645-0418-96 | Pharma | 177 ml | — | — | FDA listed | — |
| Calamine 160 mg/mL 82645-0900-96 | Pharma | 177 ml | — | — | FDA listed | — |
| Calamine 80 mg/mL; 80 mg/mL 85786-0703-06 | Farmacias | 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.
🔬 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 8% and Zinc Oxide 8% — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 40%
Female · 60%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00395-0413-96 You're viewing this | 177 mL in 1 BOTTLE, PLASTIC (0395-0413-96) | 2017-11-13 | Active |
🧭 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 FDA registers it as 0395-0413-96, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00395-0413-96, written without dashes as 00395041396. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00395-0413-96, the first segment (00395) is the labeler code FDA assigned to Humco holding Group, Inc.; the middle segment (0413) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (96) identifies this exact package size and type. Together they name one specific package of one specific product.
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.
📄 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 ▾
Uses dries the oozing and weeping o poison ivy, poison oak, and poison sumac.
⏱️ Dosage and Administration ▾
Directions Adults and children 2 years of age and older: shake well before using. Cleanse the skin with soap and water and dry the area before application. Apply lotion 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 ▾
Warnings For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.
🧪 Active Ingredient ▾
Active Ingredients Calamine 8% and Zinc Oxide 8%
🧪 Inactive Ingredients ▾
Inactive ingredients Bentonite magma, calcium hydroxide, carrageenan, glycerin, microcrystalline cellulose, purified water, and xanthan gum.
🎯 Purpose ▾
Purpose Skin protectant
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.