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Calmol 4 Zinc Oxide and Cocoa Butter 270 mg; 2052 mg Suppository, 12 suppositories — NDC 67492-0104-12 package photo

Calmol 4 Zinc Oxide and Cocoa Butter 270 mg; 2052 mg Suppository, 12 suppositories

by Resical Inc. · 2 BLISTER PACK in 1 CARTON (67492-104-12) / 6 SUPPOSITORY in 1 BLISTER PACK
NDC 67492-0104-12
🏷️ FDA NDC (as labeled) 67492-104-12 billing pads the product segment with a zero
This package
Contains12 suppositories Pack sizes3 compare ↓
Also comes in: 2 suppositories 67492-0104-13 24 suppositories 67492-0104-11
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) 67492-104-12
Product NDC 67492-104
11-digit billing NDC 67492010412
NCPDP billing unit EA — each (per item)
RxCUI 1049137, 1113714
UNII SOI2LOH54Z, 512OYT1CRR
Application # M015
SPL Set ID 5516f800-d3fa-4b90-a3eb-c0bdf3183b9b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-05-13
Route RECTAL
Dosage form SUPPOSITORY
Substance ZINC OXIDE; COCOA BUTTER
GPI-14 89400000005200
GPI class Calmol-4
GCN Seq No 068458
GCN 31239
HICL code 038418
Ingredient (HICL) Cocoa Butter/Zinc Oxide
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q3
Therapeutic class — intermediate (HIC2) Anal-Rectal Preparations
HIC3 code Q3D
Therapeutic class — specific (HIC3) Hemorrhoidal Preparations
AHFS code 84:92.00.00
AHFS class Skin And Mucous Membrane Agents, Misc.
FDB label name CALMOL 4 SUPPOSITORY
FDB brand name Calmol 4
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 67492-104-12 — 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 → 67492-0104-12. 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

LabelerResical Inc.
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code67492
First marketedMay 2006
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 CALMOL 4 SUPPOSITORY Ingredient Cocoa Butter/Zinc Oxide
🧪 What is this product?

Calmol 4 is a rectal suppository containing zinc oxide and cocoa butter. Zinc oxide is commonly used in topical products for its mild protective and soothing properties on irritated skin. Cocoa butter functions as an emollient and lubricant base in suppository formulations. This is an over-the-counter monograph product, meaning it is marketed under FDA's established category rules for this type of medicine rather than through individual product approval.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII YIW503MI7V
    Bismuth subgallate is a mineral compound that works as an astringent and binding agent in medicines. It helps firm up formulations and is often used in products designed for digestive or skin applications.
  • UNII 8334LX7S21
    A solid fat derived from animal or vegetable sources, used as a coating agent and lubricant to help pills slide smoothly during manufacturing and protect the medicine from moisture and air.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.

5 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesBismuth subgallate, glyceryl stearate, hydrogenated vegetable oil, methylparaben, propylparaben

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 systemPer eachPer 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: 2 suppositories 24 suppositories
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
Calmol 4 270 mg/1; 2052 mgthis 67492-0104-12 Resical 12 suppositories — — 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

🏛️
2006
On the market since
May 2006
📍
2026
Currently FDA-listed
20 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
67492-0104-11 4 BLISTER PACK in 1 CARTON (67492-104-11) / 6 SUPPOSITORY in 1 BLISTER PACK 2006-05-13 Active
67492-0104-12 You're viewing this 2 BLISTER PACK in 1 CARTON (67492-104-12) / 6 SUPPOSITORY in 1 BLISTER PACK 2006-05-13 Active
67492-0104-13 1 BLISTER PACK in 1 CARTON (67492-104-13) / 2 SUPPOSITORY in 1 BLISTER PACK 2006-05-13 Active

Pack size FAQ

What quantity is in NDC 67492-0104-12?
NDC 67492-0104-12 contains 12 suppositories — 2 blister pack in 1 carton / 6 suppository in 1 blister pack.
What is the difference between NDC 67492-0104-12 and NDC 67492-0104-13?
Both are Calmol 4 Zinc Oxide and Cocoa Butter 270 mg; 2052 mg Suppository — the drug itself is identical. NDC 67492-0104-12 is the 12 suppositories package, while NDC 67492-0104-13 is the 2 suppositories package.
What NDC number is used to bill for this package of Calmol 4 Zinc Oxide and Cocoa Butter 270 mg; 2052 mg Suppository?
Bill NDC 67492-0104-12 — the 11-digit billing format is 67492010412. 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 67492-104-12, 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: 67492-0104-12, written without dashes as 67492010412. 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 67492-0104-12, the first segment (67492) is the labeler code FDA assigned to Resical Inc.; the middle segment (0104) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) 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 Resical 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 2 other package presentations of this same product, including 2 suppositories (67492-0104-13), 24 suppositories (67492-0104-11). 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?
Resical 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 35 words ▾

Uses gives temporary relief of burning, irritation, itching and discomfort associated with hemorrhoids temporarily provides a coating for for anorectal discomforts temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

⏱️ Dosage and Administration 92 words ▾

Directions adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product detach one suppository from the strip; remove wrapper before inserting into rectum as follows: slowly peel down film wrapper by pulling evenly and slowly on tabs to expose suppository insert 1 suppository bulb shape first into the rectum up to 6 times daily or after each bowl movement children under 12 years of age, consult a doctor

⚠️ Warnings 69 words ▾

Warnings For rectal use only When using this product do not exceed the recommended daily dosage unless directed by a doctor Stop use and ask doctor if bleeding occurs or if condition worsens or does not improve within 7 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 11 words ▾

Active Ingredients (in each suppository) Cocoa Butter 76% Zinc Oxide 10%

🧪 Inactive Ingredients 11 words ▾

Inactive ingredients Bismuth subgallate, glyceryl stearate, hydrogenated vegetable oil, methylparaben, propylparaben

🎯 Purpose 3 words ▾

Purpose Protectant Astringent

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 67480-0001-01 · Central 67492-0105-11 · ResiCal, →
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.