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Calprotect Menthol, Zinc Oxide 20.6 g/100g; .44 g/100g Ointment, 113 g — NDC 69618-0067-82 package photo

Calprotect Menthol, Zinc Oxide 20.6 g/100g; .44 g/100g Ointment, 113 g

by Reliable 1 Laboratories LLC · 113 g in 1 TUBE (69618-067-82)
NDC 69618-0067-82
🏷️ FDA NDC (as labeled) 69618-067-82 billing pads the product segment with a zero
This package
Contains113 g Pack sizes2 compare ↓
Also comes in: 71 g 69618-0067-71
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 69618-067-82
Product NDC 69618-067
11-digit billing NDC 69618006782
NCPDP billing unit GM — per gram (weight)
RxCUI 2123045, 2702497
UNII SOI2LOH54Z, L7T10EIP3A
UPC 0369618067820
Application # M015
SPL Set ID 09fb2810-0cc1-b2e2-e063-6294a90a4576
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-01-01
Route TOPICAL
Dosage form OINTMENT
Substance ZINC OXIDE; MENTHOL
GPI-14 90979902454219
GPI class CalProtect
GCN Seq No 065841
GCN 27937
HICL code 002350
Ingredient (HICL) Menthol/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 84:24.12.00
AHFS class Basic Ointments And Protectants
FDB label name CALPROTECT 0.44%-20.6% OINT
FDB brand name Calprotect
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 69618-067-82 — 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 → 69618-0067-82. 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

LabelerReliable 1 Laboratories LLC
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code69618
First marketedJan 2021
Product typeHuman Otc Drug
Portfolio26 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 CALPROTECT 0.44%-20.6% OINT Ingredient Menthol/Zinc Oxide
🧪 What is this product?

Calprotect Menthol is a topical ointment marketed as an over-the-counter product under FDA's monograph rules for its category. It contains menthol and zinc oxide, ingredients commonly used in skin care products for topical application. Menthol is typically included for a cooling or soothing sensation, while zinc oxide functions as a barrier ingredient and is often used in products designed to protect and soothe skin. This product is applied directly to the skin surface.

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.

🧪 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.

💲 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.
Try another pack size: 71 g
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Walgreens Moisture Barrier .44 g/100g; 20.6 g/100g 00363-2792-01 Walgreens 24 tubes — — FDA listed —
Walgreens Moisture Barrier .44 g/100g; 20.6 g/100g 00363-3680-04 Walgreen 1 tube — — FDA listed —
Moisture Barrier 20.6 g/100g; .44 g/100g 00363-6254-07 Walgreen 113 g — — FDA listed —
Menthol and Zinc Oxide .44 g/100g; 20.625 g/100g 10135-0701-04 Marlex 113 g — — FDA listed —
Menthol and Zinc Oxide .44 g/100g; 21 g/100g 67777-0234-01 Dynarex 144 pouches — — FDA listed —
Calprotect 20.6 g/100g; .44 g/100gthis 69618-0067-82 Reliable 113 g — — FDA listed —
Menthol and Zinc Oxide .44 g/100g; 20.625 g/100g 69771-0013-23 GERI-GENTLE 113 g — — FDA listed —
Hydroseptine .44 g/100g; 20.6 g/100g 71399-6743-01 AKRON 100 g — — FDA listed —
Pharmacy Choice .44 g/100g; 20.6 g/100g 87228-3010-01 PHARMACY 113 g — — FDA listed —
Zinc Oxide and Menthol .44 g/100g; 20.6 g/100g 87455-0001-01 Akron 113 g — — 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

🏛️
2021
On the market since
Jan 2021
📍
2026
Currently FDA-listed
5 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69618-0067-71 71 g in 1 JAR (69618-067-71) 2021-01-01 Active
69618-0067-82 You're viewing this 113 g in 1 TUBE (69618-067-82) 2021-01-01 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 69618-0067-82?
NDC 69618-0067-82 contains 113 g — 113 g in 1 tube.
What is the difference between NDC 69618-0067-82 and NDC 69618-0067-71?
Both are Calprotect Menthol, Zinc Oxide 20.6 g/100g; .44 g/100g Ointment — the drug itself is identical. NDC 69618-0067-82 is the 113 g package, while NDC 69618-0067-71 is the 71 g package.
What NDC number is used to bill for this package of Calprotect Menthol, Zinc Oxide 20.6 g/100g; .44 g/100g Ointment?
Bill NDC 69618-0067-82 — the 11-digit billing format is 69618006782. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 69618-067-82, 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: 69618-0067-82, written without dashes as 69618006782. 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 69618-0067-82, the first segment (69618) is the labeler code FDA assigned to Reliable 1 Laboratories LLC; the middle segment (0067) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (82) 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 Reliable 1 Laboratories LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 71 g (69618-0067-71). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Reliable 1 Laboratories 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.

📄 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 30 words ▾

Uses A moisture barrier that prevents and helps heal skin irritations from urine diarrhea perspiration fistula drainage feeding tube site leakage wound drainage (per-wound skin) minor burns cuts scrapes itching

⏱️ Dosage and Administration 45 words ▾

Directions Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Calprotect Ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

⚠️ Warnings 65 words ▾

Warnings For external use only Not for deep or puncture wounds Avoid contact with eyes Incase of accidental ingestion, contact a physician or posion contril immediately If condition worsens or does not improve in 7 days, consult a doctor Do not put this product into the rectum by using fingers or any machanical device or applicator Children under 12 years of age: consult a doctor

📦 Storage and Handling 6 words ▾

Other information Store between 15-30°C (59-86°F)

🧪 Active Ingredient 7 words ▾

Active ingredients Menthol 0.44% Zinc Oxide 20.6%

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients calamine, chlorothymol, glycerin, lanolin, phenol, sodium bicarbonate, and thymol in a suitable ointment base

🎯 Purpose 10 words ▾

Purpose External analgesic / Anti-itch Skin protectant / Anorectal astrigent

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69618-0066-02 · Reliable 69618-0068-54 · RELIABLE →
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.