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Cirlutone Camphor .6 g/100g Ointment, 100 g — NDC 71917-0001-35 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cirlutone Camphor .6 g/100g Ointment, 100 g — NDC 71917-001-35 (Billing 71917-0001-35)

by Herbal Health LLC · 100 g in 1 BOTTLE

This is a package of 100 g of Cirlutone Camphor .6 g/100g Ointment from Herbal Health LLC, marketed since Dec 2017 and currently FDA-listed. It is this product's only package size.

NDC 71917-0001-35
🏷️ FDA NDC (as labeled) 71917-001-35 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 71917-001-35 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
71917 labeler · 001 product · 35 package
Package marketed since
Dec 6, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7191700135 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71917-001-35
Product NDC 71917-001
11-digit billing NDC 71917000135
RxCUI 1991259
UNII 5TJD82A1ET
Application # part348
SPL Set ID 5b114844-1cb8-4e2c-961c-d9b91b8589f4
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH NOT FINAL
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-12-06
Route TOPICAL
Dosage form OINTMENT
Substance CAMPHOR (SYNTHETIC)
Quick answers
  • RxCUI (RxNorm): 1991259
Why two NDCs? The FDA registers this code as 71917-001-35 — 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 → 71917-0001-35. 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?

Cirlutone Camphor is a topical ointment containing synthetic camphor, marketed as an over-the-counter product under FDA's monograph rules for its category. Camphor is typically used in topical products for its cooling and counterirritant properties, commonly applied to skin to create a sensation of cooling relief. This ointment is intended for external application only.

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
71917-0001-35 You're viewing this Main listing 100 g in 1 BOTTLE 2017-12-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cirlutone .6 g/100gthis 71917-0001-35 Herbal 100 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

🏛️
2017
On the market since
Dec 2017
📍
2026
Currently FDA-listed
9 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.

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 T1F4GB8MNL
    A plant extract derived from angelica anomala root, used as a flavoring agent and natural fragrance component to improve the taste and aroma of medicines.
  • UNII 67ZYA5T02K
    Frankincense oil is a natural aromatic extract from tree resin. In medicines, it's used as a fragrance and flavoring agent to improve taste and smell, and may also help preserve the product.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 8Y1N3NX2DW
    A plant extract derived from the Ligusticum wallichii herb. In medicines, it may serve as a natural flavoring agent, preservative, or active botanical ingredient depending on the formulation.
  • UNII GDO2997SZZ
    A plant extract from magnolia flowers used as a natural flavoring agent and botanical ingredient to add taste and aroma to the medicine.
  • 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 T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • 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.
  • UNII X8KX602M5L
    Sophora flavescens is a plant extract used in medicines as a natural thickening agent and skin-conditioning ingredient. It helps adjust the medicine's texture and may support formulation stability.
  • UNII EY9MMA0P6Y
    A spice derived from clove flower buds. It's used as a flavoring agent and natural preservative to add taste and help maintain product stability in medicines.
  • 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 7G1J5DA97F
    White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.

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

The official label also statesAngelica anemala, Emulsifying Wax NF, Fragrance, Frankincense Oil, Isopropyl alcohol, Ligusticum wallichii, Magnolia liliflora, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Purified Water, Sophora, Syzgium armaticum

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.

Manufacturer & labeler

LabelerHerbal Health LLC
FDA applicationpart348 (OTC MONOGRAPH NOT FINAL)
Labeler code71917
First marketedDec 2017
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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📋 Description 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

For the temporary relief of pain associated with: sunburn minor cuts scrapes

⏱️ Dosage and Administration 32 words ▾

Adults and children 2 years of age and older : apply to affected area not more than 3 to 4 times daily. Children under 2 yrs of age : consult a doctor.

⚠️ Warnings 82 words ▾

For External Use only. Flammable: keep away from fire or flame When using this product avoid contact with eyes or mucous membrane use only as directed Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days If pregnant or breastfeeding , ask a healthcare professional before use. Keep out of reach of children .

If swallowed, get medical help or contact a Poison Control Center immediately.

📦 Storage and Handling 18 words ▾

Store in a cool & dry place Do not use if tamper evident seal is broken or missing

🧪 Active Ingredient 2 words ▾

Camphor 0.6%

🧪 Inactive Ingredients 24 words ▾

Angelica anemala, Emulsifying Wax NF, Fragrance, Frankincense Oil, Isopropyl alcohol, Ligusticum wallichii, Magnolia liliflora, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Purified Water, Sophora, Syzgium armaticum

🎯 Purpose 3 words ▾

Camphor 0.6%...............Topical Analgesic

📋 Description 24 words ▾

Herbal Health L.L.C. Made in the U.S.A. www.cirlutone.com

Exp. Date: Lot No.: Manufactured by: Neutraderm, Inc. 20660 Nordhoff St. Chatsworth, CA. 91311 [email protected] www.cirlutone.com

📄 When Using This Product 71 words ▾

When using this product avoid contact with eyes or mucous membrane use only as directed Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days If pregnant or breastfeeding , ask a healthcare professional before use. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately.

📄 Stop Use and Ask a Doctor If 56 words ▾

Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days If pregnant or breastfeeding , ask a healthcare professional before use. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately.

🤰 If Pregnant or Breast-Feeding 30 words ▾

If pregnant or breastfeeding , ask a healthcare professional before use. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately.

📄 Questions or Comments 7 words ▾

Call 310-888-8878 Monday through Friday, 9am-5pm CST.

📄 Package Label / Principal Display Panel 8 words ▾

CIRLUTONE Ointment Topical Analgesic Net Wt. 3.53oz/100g. CirlutoneCarton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Cirlutone (this brand).

Top reported reactions

Fatigue30
Drug Hypersensitivity29
Pain29
Pruritus26
Headache24
Pneumonia24
Dyspnoea23

Age at onset

Neonate1
Infant1
Adolescent1
Adult19
Elderly16

Reporter sex

167 reports
Male · 39%
Female · 61%

Serious outcomes

Hospitalization76
Death14
Life-threatening9
Disabling4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 32 2
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.

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 Not Final". 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 Herbal Health LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Herbal Health 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.
← 71912-0521-42 · Advantage 71918-0001-05 · Timing →
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.