![H-Cold Sores Formula calendula officinalis, ranunculus bulbosus 12 [hp_C]/11mL; 12 [hp_C]/11mL Oil, 11 mL — NDC 61077-0127-11 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=425bc0e8-c884-40cc-90e9-490e50f733c3&name=HColdSoresLabel.jpg)
H-Cold Sores Formula calendula officinalis, ranunculus bulbosus 12 [hp_C]/11mL; 12 [hp_C]/11mL Oil, 11 mL
by Healing Natural Oils LLC · 11 mL in 1 BOTTLE, DROPPER (61077-127-11)
NDC 61077-0127-11
🏷️ FDA NDC (as labeled)
61077-127-11
billing pads the product segment with a zero
This package
Contains11 mL
Pack sizes2 compare ↓
Also comes in:
33 ml 61077-0127-33
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)
61077-127-11
Product NDC
61077-127
11-digit billing NDC
61077012711
UNII
18E7415PXQ, AEQ8NXJ0MB
SPL Set ID
425bc0e8-c884-40cc-90e9-490e50f733c3
DEA schedule
Non-controlled
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2013-11-06
Route
TOPICAL
Dosage form
OIL
Substance
CALENDULA OFFICINALIS FLOWERING TOP; RANUNCULUS BULBOSUS
Why two NDCs?
The FDA registers this code as 61077-127-11 — 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 → 61077-0127-11. 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
LabelerHealing Natural Oils LLC
Labeler code61077
First marketedNov 2013
Product typeHuman Otc Drug
Portfolio26 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?
H-Cold Sores Formula is an unapproved homeopathic oil product applied topically to the skin. It contains calendula officinalis (marigold) and ranunculus bulbosus (buttercup), which are used in homeopathic practice for their traditional properties related to skin irritation and sores. Homeopathic products are marketed based on homeopathic tradition rather than FDA evaluation for safety or effectiveness.
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 calendula officinalis, ranunculus bulbosus?
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 7K1N3UZ6DU
A plant-derived essential oil from cymbopogon martini grass, used primarily as a fragrance and flavoring agent to improve the taste and aroma of medications.
-
UNII 19AH1RAF4M
A plant extract from lavender flowers used as a flavoring and fragrance agent in medicines. It adds taste and aroma to make the product more pleasant to take.
-
UNII R3617MQA5Z
A natural oil extracted from litsea cubeba fruit, used as a fragrance and flavoring agent to improve the taste or aroma of the medication.
-
UNII G43C57162K
A natural plant extract from tea tree leaves used in topical formulations. It acts as a fragrance, preservative, and antimicrobial agent to help maintain product freshness and sensory appeal.
-
UNII 0E553RP62F
A plant extract from geranium that adds scent and flavor to the medicine. It serves as a natural flavoring and aromatic agent in oral formulations.
5 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesEssential Oil Blend (Cymbopogon martinii aerial parts, Lavandula officinalis flower bud, Litsea cubeba seed, Melaleuca alternifolia leaf-branch, Pelargonium graveolens whole plant)
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 each | 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
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:
33 ml
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 |
|---|---|---|---|---|---|---|
| H-Cold Sores Formula 12 [hp_C]/11mL; 12 [hp_C]/11mLthis 61077-0127-11 | Healing | 11 ml | — | — | 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
🏛️
2013
On the market since
Nov 2013
📍
2026
Currently FDA-listed
13 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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 61077-0127-11 You're viewing this | 11 mL in 1 BOTTLE, DROPPER (61077-127-11) | 2013-11-06 | Active |
| 61077-0127-33 | 33 mL in 1 BOTTLE, DROPPER (61077-127-33) | 2013-11-06 | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 61077-0127-11?
NDC 61077-0127-11 contains 11 mL — 11 ml in 1 bottle, dropper.
What is the difference between NDC 61077-0127-11 and NDC 61077-0127-33?
Both are H-Cold Sores Formula calendula officinalis, ranunculus bulbosus 12 [hp_C]/11mL; 12 [hp_C]/11mL Oil — the drug itself is identical. NDC 61077-0127-11 is the 11 mL package, while NDC 61077-0127-33 is the 33 ml package.
What NDC number is used to bill for this package of H-Cold Sores Formula calendula officinalis, ranunculus bulbosus 12 [hp_C]/11mL; 12 [hp_C]/11mL Oil?
Bill NDC 61077-0127-11 — the 11-digit billing format is 61077012711. 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
H-Cold Sores Formula calendula officinalis, ranunculus bulbosus 12 [hp_C]/11mL; 12 [hp_C]/11mL OIL 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 61077-127-11, 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: 61077-0127-11, written without dashes as 61077012711. 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 61077-0127-11, the first segment (61077) is the labeler code FDA assigned to Healing Natural Oils LLC; the middle segment (0127) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) 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 Healing Natural Oils LLC. 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 33 ml (61077-0127-33). 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?
Healing Natural Oils LLC 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
📋 Description
🎯 Indications and Usage ▾
Indications: For the treatment of cold sore symptoms, such as fever blisters, soreness at blister site.
⏱️ Dosage and Administration ▾
Directions: Adults and Children 4 yrs and over: Wash hands before and after use. Shake well and apply 1 or 2 drops to a cotton swab and apply directly to the affected area 3x per day. Do not oversaturate or exceed dosage.
⚠️ Warnings ▾
Warnings: For external use only. Perform skin test prior to initial use. Do not use if pregnant or breastfeeding. Keep out of reach of children. Keep away from eyes and mucous membranes. If swallowed get medical help or contact a Poison Control Center right away. Discontinue use if irritation occurs. Consult a doctor if symptoms worsen after 7 days.
🧪 Active Ingredient ▾
Active Ingredients: Calendula officinalis -12C HPUS, Ranunculus bulbosus- 12C HPUS
🧪 Inactive Ingredients ▾
Inactive Ingredients: Essential Oil Blend (Cymbopogon martinii aerial parts, Lavandula officinalis flower bud, Litsea cubeba seed, Melaleuca alternifolia leaf-branch, Pelargonium graveolens whole plant)
🎯 Purpose ▾
Purpose Calendula officinalis -12C HPUS (for herpes, healing agent), Ranunculus bulbosus -12C HPUS (herpetic eruptions) The letters ‘HPUS’ indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States
📋 Description ▾
Dist. by Healing Natural Oils 1042 N El Camino Real, #B-426, Encinitas, CA 92024 USA
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.