Calmoseptine anorectal ointment 15.7 g/100g; .44 g/100g; 24 g/100g; 20.6 g/100g Ointment, 71 g
by Calmoseptine Inc. · 71 g in 1 TUBE (0799-0001-02)
NDC 00799-0001-02
🏷️ FDA NDC (as labeled)
0799-0001-02
billing pads the labeler segment with a zero
This package
Contains71 g
Pack sizes5 compare ↓
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)
0799-0001-02
Product NDC
0799-0001
11-digit billing NDC
00799000102
NCPDP billing unit
GM — per gram (weight)
UNII
7EV65EAW6H, L7T10EIP3A, 4T6H12BN9U, SOI2LOH54Z
UPC
0746876000460
Application #
M015
SPL Set ID
ff9539ed-d9ae-401d-adbc-df8f1d751431
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
1950-08-01
Route
TOPICAL
Dosage form
OINTMENT
Substance
LANOLIN; MENTHOL; PETROLATUM; ZINC OXIDE
GPI-14
90979902454219
GPI class
Calmoseptine
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
CALMOSEPTINE OINTMENT
FDB brand name
Calmoseptine
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0799-0001-02 — 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 → 00799-0001-02. 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
LabelerCalmoseptine Inc.
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code00799
First marketedAug 1950
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.
🩺 Clinical
Label name CALMOSEPTINE OINTMENT Ingredient Menthol/Zinc Oxide
🧪 What is this product?
Calmoseptine is an over-the-counter ointment applied to the skin around the anus. It contains lanolin and petrolatum, which function as moisturizers and protective barriers, along with zinc oxide, commonly used in ointments to protect skin and reduce moisture. Menthol is included for a cooling, soothing sensation. This product is marketed under FDA's monograph rules for anorectal ointments, rather than as an individually reviewed drug application.
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 anorectal ointment?
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 LJ25TI0CVT
Chlorothymol is a synthetic antimicrobial compound used as a preservative in medicines. It helps prevent bacterial and fungal growth to keep the product stable and safe during storage.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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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 339NCG44TV
Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
-
UNII 8MDF5V39QO
A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
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UNII 3J50XA376E
Thymol is a natural compound derived from thyme and other plants. It acts as a preservative and flavoring agent in medicines, helping prevent microbial growth and add taste.
6 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescalamine, chlorothymol, glycerin, phenol, sodium bicarbonate, and thymol in a suitable ointment base
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
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 |
|---|---|---|---|---|---|---|
| Calmoseptine 15.7 g/100g; .44 g/100g; 24 g/100g; 20.6 g/100gthis 00799-0001-02 | Calmoseptine | 71 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
🏛️
1950
On the market since
Aug 1950
📍
2026
Currently FDA-listed
76 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 Calmoseptine (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 39%
Female · 61%
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 |
|---|---|---|---|
| 00799-0001-02 You're viewing this | 71 g in 1 TUBE (0799-0001-02) | 1999-01-04 | Active |
| 00799-0001-03 | 71 g in 1 JAR (0799-0001-03) | 1950-08-01 | Active |
| 00799-0001-04 | 113 g in 1 TUBE (0799-0001-04) | 1988-08-01 | Active |
| 00799-0001-05 | 3.5 g in 1 PACKET (0799-0001-05) | 2001-06-01 | Active |
| 00799-0001-06 | 20 g in 1 TUBE (0799-0001-06) | 2017-07-03 | Active |
Pack size FAQ
What quantity is in NDC 00799-0001-02?
NDC 00799-0001-02 contains 71 g — 71 g in 1 tube.
What is the difference between NDC 00799-0001-02 and NDC 00799-0001-05?
Both are Calmoseptine anorectal ointment 15.7 g/100g; .44 g/100g; 24 g/100g; 20.6 g/100g Ointment — the drug itself is identical. NDC 00799-0001-02 is the 71 g package, while NDC 00799-0001-05 is the 3.5 g package.
What NDC number is used to bill for this package of Calmoseptine anorectal ointment 15.7 g/100g; .44 g/100g; 24 g/100g; 20.6 g/100g Ointment?
Bill NDC 00799-0001-02 — the 11-digit billing format is 00799000102. 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) | ✓ 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 0799-0001-02, 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: 00799-0001-02, written without dashes as 00799000102. 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 00799-0001-02, the first segment (00799) is the labeler code FDA assigned to Calmoseptine Inc.; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Calmoseptine Inc.. 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 4 other package presentations of this same product, including 3.5 g (00799-0001-05), 20 g (00799-0001-06), 71 g (00799-0001-03). 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?
Calmoseptine 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 Temporarily protects irritated areas. For the temporary relief of: local itching and discomfort in the perianal area pain or burning skin irritations
⏱️ Dosage and Administration ▾
Directions Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth or air dry before application of this product. Apply externally to the affected area up to 6 times daily or after each bowel movement. Children under 12 years of age: consult a doctor.
⚠️ Warnings ▾
Warnings For external use only When using this product * Certain persons can develop allergic reactions to ingredients in this product. * Do not put this product into the rectum by using fingers or any mechanical device or applicator. * Do not exceed the recommended daily dosage unless directed by a doctor. * Avoid contact with eyes.
🧪 Active Ingredient ▾
Active Ingredients Lanolin 15.7% Menthol 0.44% Petrolatum 24% Zinc Oxide 20.6% Purpose Active Ingredients Purpose Lanolin 15.7%...........................Anorectal Protectant Menthol 0.44%...........................Anorectal Analgesic Petrolatum 24%........................Anorectal Protectant Zinc Oxide 20.6%......Anorectal Protectant, Astringent
🧪 Inactive Ingredients ▾
Inactive Ingredients: calamine, chlorothymol, glycerin, phenol, sodium bicarbonate, and thymol in a suitable ointment base
🎯 Purpose ▾
Purpose Active Ingredients Purpose Lanolin 15.7%...........................Anorectal Protectant Menthol 0.44%...........................Anorectal Analgesic Petrolatum 24%........................Anorectal Protectant Zinc Oxide 20.6%......Anorectal Protectant, Astringent
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.