Home › NDC Lookup › Ingredients › Menthol And Zinc Oxide › 67777-0234-03
🧴image loading
(from DailyMed)

Menthol and Zinc Oxide .44 g/100g; 21 g/100g Ointment — NDC 67777-234-03 (Billing 67777-0234-03)

by Dynarex Corporation · 24 TUBE in 1 CASE / 113 g in 1 TUBE

This is a package of Menthol and Zinc Oxide .44 g/100g; 21 g/100g Ointment from Dynarex Corporation, marketed since May 2010 and currently FDA-listed.

NDC 67777-0234-03
🏷️ FDA NDC (as labeled) 67777-234-03 billing pads the product segment with a zero
This package
Contains113 g in 1 tube Pack sizes2 compare ↓
Product page 67777-0234-01 Also comes in: 144 pouches 67777-234-01
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 67777-234-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
67777 labeler · 234 product · 03 package
Package marketed since
May 11, 2010
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0616784127514
FDA record last changed
Jul 24, 2026
🚨
Active recall for this product.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0213-2026
Lots / codes: Lot #: A482305 · reported Dec 10, 2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 67777-234-03
Product NDC 67777-234
11-digit billing NDC 67777023403
NCPDP billing unit GM — per gram (weight)
RxCUI 2123045
UNII L7T10EIP3A, SOI2LOH54Z
UPC 0616784127514
Application # M017
SPL Set ID d0e43651-4215-465b-9ace-1bc23126b109
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-05-11
Route TOPICAL
Dosage form OINTMENT
Substance MENTHOL; ZINC OXIDE

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

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 CALASOOTHE 0.44%-20.6% OINT
FDB brand name Calasoothe
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 065841
  • GCN: 27937
  • HICL (First Databank): 002350
  • AHFS class code: 84:24.12.00
  • RxCUI (RxNorm): 2123045
Why two NDCs? The FDA registers this code as 67777-234-03 — 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 → 67777-0234-03. 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 CALASOOTHE 0.44%-20.6% OINT Ingredient Menthol/Zinc Oxide
🧪 What is this product?

This is a topical ointment containing menthol and zinc oxide, marketed as an over-the-counter monograph drug. Menthol is commonly used in skin products for its cooling sensation and mild soothing properties, while zinc oxide functions as a barrier and is typically included in products for skin protection and moisture management. The combination is often used in formulations intended for minor skin irritation or chafing.

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.
Try another pack size: 144 pouches
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
67777-0234-01 67777-234-01 Main listing 2 BOX in 1 CASE / 144 POUCH in 1 BOX / 3.5 g in 1 POUCH 2010-05-11 — Active
67777-0234-03 You're viewing this 24 TUBE in 1 CASE / 113 g in 1 TUBE 2010-05-11 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 24 tube in 1 case / 113 g in 1 tube.
What NDC number is used to bill for this package of Menthol and Zinc Oxide .44 g/100g; 21 g/100g Ointment?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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/100gthis 67777-0234-03 Dynarex 24 tubes — — FDA listed —
Calprotect 20.6 g/100g; .44 g/100g 69618-0067-71 Reliable 71 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

🏛️
2010
On the market since
May 2010
📍
2026
Currently FDA-listed
16 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

LabelerDynarex Corporation
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code67777
First marketedMay 2010
Product typeHuman Otc Drug
Portfolio60 products on file

More NDCs from Dynarex Corporation labeler code 67777

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 41 words ▾

Uses • A moisture barrier that prevents and helps heal skin irritations from: • Urine • Diarrhea • Perspiration • Fistula drainage • Feeding tube site leakage • Wound drainage (peri-wound skin) • Minor burns • Cuts • Scrapes • Itching

⏱️ Dosage and Administration 46 words ▾

Directions • Cleanse skin with mild skin cleanser. • Pat dry or allow to air dry. • Apply a thin layer of Calasoothe 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 71 words ▾

Warnings For external use only When using this product • Avoid contact with eyes Do not use section • On deep or puncture wounds Stop use 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 If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 7 words ▾

Active Ingredient Menthol 0.44% Zinc Oxide 20.625%

🧪 Inactive Ingredients 14 words ▾

Inactive Ingredients Calamine, Glycerine, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol, White Soft Paraffin

🎯 Purpose 5 words ▾

Purpose External Analgesic Skin Protectant

📄 Do Not Use 10 words ▾

Do not use section • On deep or puncture wounds

📄 When Using This Product 9 words ▾

When using this product • Avoid contact with eyes

📄 Stop Use and Ask a Doctor If 27 words ▾

Stop use 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 20 words ▾

Keep Out Of Reach Of Children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Other Information 30 words ▾

Other Information • Store at room temperature 15º-30º C (59º-86º F) • Tamper evident. Do not use if packet is torn or cut. Do not use if seal is damaged.

📄 Questions or Comments 9 words ▾

Questions? 1-888-DYNAREX Monday - Friday, 9AM - 5PM EST

📄 Package Label / Principal Display Panel 20 words ▾

Label Calasoothe 4 oz. tube 1275 IN MASTER

Label 1271 Calasoothe 1271 BX MASTER

Label 1271 Calasoothe 1271 BX STIS010

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 Menthol and Zinc Oxide — the ingredient across all brands.

Top reported reactions

Urinary Tract Infection1

Reporter sex

1 reports
Male · 100%

Serious outcomes

Hospitalization1
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 1 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 — Not published for this NDC No photo available yet for this listing.
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 Dynarex Corporation. 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 144 pouches (67777-0234-01). 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?
Dynarex Corporation 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.
← 67777-0231-11 · Dynarex 67777-0236-02 · Dynarex →
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.