Calendula 1 [hp_X]/g Cream, 5 g — NDC 00220-1109-93 package photo

Calendula 1 [hp_X]/g Cream, 5 g

by Laboratoires Boiron · 5 g in 1 POUCH (0220-1109-93)
NDC 00220-1109-93
🏷️ FDA NDC (as labeled) 0220-1109-93 billing pads the labeler segment with a zero
This package
Contains5 g Pack sizes3 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) 0220-1109-93
Product NDC 0220-1109
11-digit billing NDC 00220110993
UNII 18E7415PXQ
SPL Set ID 2ed51803-5ec2-4163-ad12-2bf441551f07
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-03-21
Route TOPICAL
Dosage form CREAM
Substance CALENDULA OFFICINALIS FLOWERING TOP
GPI-14 99870010003700
GPI class Calendula
Why two NDCs? The FDA registers this code as 0220-1109-93 — 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 → 00220-1109-93. 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

LabelerLaboratoires Boiron
Labeler code00220
First marketedMar 2006
Product typeHuman Otc Drug
Portfolio40 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

🧪 What is this product?

This is an unapproved homeopathic cream applied to the skin containing calendula officinalis flowering top. In homeopathic practice, calendula is traditionally used for minor skin concerns. Homeopathic products are marketed based on traditional use rather than clinical testing, and the FDA does not evaluate homeopathic drugs for effectiveness or safety.

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 1QR1QRA9BU
    A fatty alcohol derived from peanut oil or made synthetically. It serves as an emollient and thickener in creams and ointments, helping create smooth texture and improve product consistency.
  • UNII 6JVW35JOOJ
    Arachidyl glucoside is a plant-derived emulsifier and skin-conditioning agent made from arachidyl alcohol and glucose. It helps mix oil and water-based ingredients together in formulations and improves product texture and spreadability.
  • UNII 0C9AC7D6XU
    A plant-derived fat from shea nut kernels that remains after soap-making. It acts as a moisturizer, emollient, and texture enhancer in topical formulations, helping soften skin and improve product spreadability.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII 9G1OE216XY
    Docosanol is a waxy, fatty alcohol derived from plant sources. It acts as an emollient and thickener in topical medicines, helping to soften the skin and improve product texture and stability.
  • 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.
  • UNII 2C1F12C6AP
    A beneficial live bacterium used as a probiotic ingredient. It's included to support the product's probiotic function by promoting beneficial microorganisms in the digestive system.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesarachidyl alcohol, arachidyl glucoside, behenyl alcohol, Butyrospermum parkii (Shea) butter, coconut oil, glycerin, lactobacillus ferment, purified water, xanthan gum

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 DailyMedingredient 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 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: 14 g 70 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
Calendula 1 [hp_X]/g 00220-1104-51 Laboratoires 30 g FDA listed
Calendula 1 [hp_X]/g 00220-1108-59 Laboratoires 75 g FDA listed
Calendula 1 [hp_X]/gthis 00220-1109-93 Laboratoires 5 g FDA listed
Calendula 1 [hp_X]/g 00220-1105-54 Laboratoires 45 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

🏛️
2006
On the market since
Mar 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.

🔬 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 CALENDULA OFFICINALIS FLOWERING TOP — the ingredient across all brands.

Top reported reactions

Diarrhoea40
Pain40
Fatigue38
Arthralgia35
Headache35
Dizziness33
Nausea33

Age at onset

Neonate1
Adolescent2
Adult21
Elderly44

Reporter sex

0 reports
Male · 31%
Female · 69%

Serious outcomes

Hospitalization141
Disabling44
Death33
Life-threatening25
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 53 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00220-1109-63 70 g in 1 TUBE (0220-1109-63) 2006-03-21 Active
00220-1109-68 1 TUBE in 1 BOX (0220-1109-68) / 14 g in 1 TUBE 2016-02-29 Active
00220-1109-93 You're viewing this 5 g in 1 POUCH (0220-1109-93) 2022-02-17 Active

Pack size FAQ

What quantity is in NDC 00220-1109-93?
NDC 00220-1109-93 contains 5 g — 5 g in 1 pouch.
What is the difference between NDC 00220-1109-93 and NDC 00220-1109-63?
Both are Calendula 1 [hp_X]/g Cream — the drug itself is identical. NDC 00220-1109-93 is the 5 g package, while NDC 00220-1109-63 is the 70 g package.
What NDC number is used to bill for this package of Calendula 1 [hp_X]/g Cream?
Bill NDC 00220-1109-93 — the 11-digit billing format is 00220110993. 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 Homeopathic listing

About homeopathic listings

Calendula 1 [hp_X]/g CREAM is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

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 "Unapproved Homeopathic". 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 0220-1109-93, 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: 00220-1109-93, written without dashes as 00220110993. 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 00220-1109-93, the first segment (00220) is the labeler code FDA assigned to Laboratoires Boiron; the middle segment (1109) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (93) 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 Laboratoires Boiron. 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 1 tube (00220-1109-68), 70 g (00220-1109-63). 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?
Laboratoires Boiron 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 12 words

helps promote healing of minor: cuts scrapes chafing burns sunburn protects skin

⏱️ Dosage and Administration 64 words

For minor burns, immediately run cool water on the burn for several minutes and pat dry. Then apply a thin layer of Calendula Cream to affected area 3 times a day. For cuts, scrapes, chafed skin, and sunburn, first cleanse the area with mild soap, rinse, and pat dry. Then apply a thin layer of Calendula Cream to affected area 3 times a day.

⚠️ Warnings 4 words

For external use only.

🧪 Active Ingredient 28 words

Active ingredient** Calendula officinalis 1X HPUS 10% The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

🧪 Inactive Ingredients 19 words

arachidyl alcohol, arachidyl glucoside, behenyl alcohol, Butyrospermum parkii (Shea) butter, coconut oil, glycerin, lactobacillus ferment, purified water, xanthan gum

🎯 Purpose 9 words

Purpose* Calendula officinalis 1X HPUS 10% ... Healing agent

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.