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Zinc Oxide and Menthol .44 g/100g; 20.6 g/100g Ointment, 113 g — NDC 87455-0001-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Zinc Oxide and Menthol .44 g/100g; 20.6 g/100g Ointment, 113 g — NDC 87455-0001-1 (Billing 87455-0001-01)

by Akron Formulations India Private Limited · 113 g in 1 TUBE

This is a package of 113 g of Zinc Oxide and Menthol .44 g/100g; 20.6 g/100g Ointment from Akron Formulations India Private Limited, marketed since Jan 2026 and currently FDA-listed. It is this product's only package size.

NDC 87455-0001-01
🏷️ FDA NDC (as labeled) 87455-0001-1 billing pads the package segment with a zero
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 87455-0001-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
87455 labeler · 0001 product · 1 package
Package marketed since
Jan 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8745500011 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 87455-0001-1
Product NDC 87455-0001
11-digit billing NDC 87455000101
RxCUI 2123045
UNII L7T10EIP3A, SOI2LOH54Z
Application # M015
SPL Set ID 4b84556c-521f-eebd-e063-6394a90a8e1e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-01
Route TOPICAL
Dosage form OINTMENT
Substance MENTHOL; ZINC OXIDE
Quick answers
  • RxCUI (RxNorm): 2123045
Why two NDCs? The FDA registers this code as 87455-0001-1 — a 5-4-1 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 package segment → 87455-0001-01. 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 a topical ointment containing zinc oxide and menthol, marketed as an over-the-counter product under FDA's monograph rules for its category. Zinc oxide is commonly used in skin protectant products to help shield and soothe irritated skin. Menthol is typically included for its mild cooling sensation, which may provide temporary comfort to affected areas. The ointment is applied directly to the skin.

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
87455-0001-01 You're viewing this Main listing 113 g in 1 TUBE 2026-01-01 — Active

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/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/100gthis 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

🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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

LabelerAkron Formulations India Private Limited
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code87455
First marketedJan 2026
Product typeHuman Otc Drug
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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 words ▾

Uses A moisture barrier that prevents and heals skin irritations from urine diarrhea prespiration fistula drainage feeding tube site leakage wound drainage (peri-wound skin) minor burns cuts scrapes itching

⏱️ Dosage and Administration 45 words ▾

Directions Cleanse skin gently with mid skin cleanser. Pat dry or allow to air dry. apply a thin layer of Hydroseptine 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 19 words ▾

Warnings For external use only When using this product not for deep or punctured wounds avoid contact with eyes

🧪 Active Ingredient 19 words ▾

Active Ingredients Menthol 0.44% Zinc Oxide 20.6% Purpose Active Ingredients Purpose Menthol 0.44%...........................External analgesic/anti-itch Zinc Oxide 20.6%......Skin protectant/anorectal astringent

🧪 Inactive Ingredients 64 words ▾

Inactive Ingredients: Other information store at room temperature 15-30 C (59-86 F) Inactive ingredients calamine, chlorothymol, glycerin, lanoline,phenol, sodium bicarbonate, and thymol,white petrolatum Questions or Comments? Call toll-free +91 9708777888 Manufactured By: Akron Formulations India Private Limited 134B, Block-B, Bollaram, Jinnaram Mandal, Medak, Hyderabad, Telangana 502325, India (IND) This product is not manufactured or distributed by Calmoseptine Inc., owner of the registered trademark Calmoseptine.

🎯 Purpose 12 words ▾

Purpose Active Ingredients Purpose Menthol 0.44%...........................External analgesic/anti-itch Zinc Oxide 20.6%......Skin protectant/anorectal astringent

📄 Ask a Doctor Before Use If 33 words ▾

Stop use and ask doctor if In case of accidental ingestion contact a physician or Poison Control Center right away if condition worsens or does not improve within 7 days, consult a doctor

📄 When Using This Product 14 words ▾

When using this product not for deep or punctured wounds avoid contact with eyes

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Package Label / Principal Display Panel 1 words ▾

1

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 Akron Formulations India Private Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Akron Formulations India Private Limited 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.
← 87454-0425-01 · Velovita 87456-0001-01 · Brichem →
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.