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DycloPro Dyclonine Hydrochloride 5 mg/mL Solution — NDC 00362-3971-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

DycloPro Dyclonine Hydrochloride 5 mg/mL Solution — NDC 0362-3971-05 (Billing 00362-3971-05)

by Septodont Inc · 1 BOTTLE in 1 BOTTLE / 30 mL in 1 BOTTLE

This is a package of DycloPro Dyclonine Hydrochloride 5 mg/mL Solution from Septodont Inc, marketed since Sep 2019 and currently FDA-listed. It is this product's only package size.

NDC 00362-3971-05
🏷️ FDA NDC (as labeled) 0362-3971-05 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 0362-3971-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0362 labeler · 3971 product · 05 package
Package marketed since
Sep 1, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0362397105 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0362-3971-05
Product NDC 0362-3971
11-digit billing NDC 00362397105
NCPDP billing unit ML — per mL (volume)
RxCUI 1048281, 2199132
UNII ZEC193879Q
Application # ANDA200480
SPL Set ID bfd9a2dd-7b40-40c0-b256-52f613395760
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-09-01
Route TOPICAL
Dosage form SOLUTION
Substance DYCLONINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 007393
GCN 30450
HICL code 001521
Ingredient (HICL) Dyclonine Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5H
Therapeutic class — specific (HIC3) Topical Local Anesthetics
AHFS code 84:08.00.00
AHFS class Antipruritics And Local Anesthetics
FDB label name DYCLOPRO 0.5% SOLUTION
FDB brand name Dyclopro
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007393
  • GCN: 30450
  • HICL (First Databank): 001521
  • AHFS class code: 84:08.00.00
  • RxCUI (RxNorm): 1048281
Why two NDCs? The FDA registers this code as 0362-3971-05 — 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 → 00362-3971-05. 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.

RxNorm drug class

This medicine belongs to the Other local anesthetics class.

Drug family (ATC) Other local anesthetics, Anesthetics, local
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name DYCLOPRO 0.5% SOLUTION Ingredient Dyclonine Hcl

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 mLPer 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
00362-3971-05 You're viewing this Main listing 1 BOTTLE in 1 BOTTLE / 30 mL in 1 BOTTLE 2019-09-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
DycloPro 5 mg/mLthis 00362-3971-05 Septodont 1 bottle — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2019
On the market since
Sep 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerSeptodont Inc
Application holderSEPTODONT INC
FDA applicationANDA200480 (ANDA)
Labeler code00362
First marketedSep 2019
Product typeHuman Prescription Drug

More NDCs from Septodont Inc labeler code 00362

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 63 words ▾

INDICATIONS AND USAGE: Dyclonine HCl Topical Solution, USP is indicated for anesthetizing accessible mucous membranes (e.g., the mouth, pharynx, larynx, trachea, esophagus, and urethra) prior to various endoscopic procedures. Dyclonine HCl Topical Solution, USP, 0.5% topical anesthetic may also be used to block the gag reflex, to relieve the pain of oral ulcers or stomatitis and to relieve pain associated with ano-genital lesions.

⏱️ Dosage and Administration 156 words ▾

DOSAGE AND ADMINISTRATION: As with all local anesthetics, the dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. A maximum dose of 30 mL of Dyclonine HCl Topical Solution, USP 1% topical anesthetic (300 mg of dyclonine HCl) may be used, although satisfactory anesthesia is usually produced within the range of 4 to 20 mL.

For specific techniques and procedures refer to standard textbooks. Although as much as 300 mg of Dyclonine HCl Topical Solution USP (as a 1% solution) have been tolerated, this dosage as a 0.5% solution has not been administered primarily because satisfactory anesthesia in endoscopic procedures can usually be produced by lesser amounts. For specific techniques for endoscopic procedures refer to standard textbooks.

Dyclonine HCl Topical Solution, USP can be used for a period of 7 days after open.

⛔ Contraindications 30 words ▾

CONTRAINDICATIONS: Dyclonine HCl Topical Solution, USP is contraindicated in patients known to be hypersensitive (allergic) to the local anesthetic or to other components of Dyclonine HCl Topical Solution, USP .

⚠️ Warnings 89 words ▾

WARNINGS: IN ORDER TO MANAGE POSSIBLE ADVERSE REACTIONS, RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS SHOULD BE IMMEDIATELY AVAILABLE WHENEVER LOCAL ANESTHETIC AGENTS, SUCH AS DYCLONINE, ARE ADMINISTERED TO MUCOUS MEMBRANES. Dyclonine HCl Topical Solution, USP should not be injected into tissue or used in the eyes because of highly irritant properties. Dyclonine HCl Topical Solution, USP should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application since under such conditions there is the potential for rapid systemic absorption.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS: Adverse experiences following the administration of dyclonine are similar in nature to those observed with other local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature.

The following types are those most commonly reported: Central nervous system: CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.

Drowsiness following the administration of dyclonine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. Cardiovascular system: Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. Allergic: Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions.

Allergic reactions may occur as a result of sensitivity either to the local anesthetic agent or to the other ingredients used in this formulation. Allergic reactions, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

Local reactions include irritation, stinging, urethritis with and without bleeding.

🔄 Drug / Laboratory Test Interactions 27 words ▾

Drug/Laboratory Test Interactions: Dyclonine HCl Topical Solution, USP should not be used in cystoscopic procedures following intravenous pyelography because an iodine precipitate occurs which interferes with visualization.

🤰 Pregnancy 51 words ▾

Pregnancy: Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with dyclonine hydrochloride. It is also not known whether dyclonine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dyclonine hydrochloride should be given to pregnant women only if clearly needed.

🧒 Pediatric Use 16 words ▾

Pediatric Use: Safety and effectiveness in children under the age of 12 have not been established.

🆘 Overdosage ~1 min read ▾

OVERDOSAGE: Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics. (See ADVERSE REACTIONS, WARNINGS and PRECAUTIONS ). Management of local anesthetic emergencies: The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic administration.

The first step in the management of convulsions consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously.

The clinician should be familiar, prior to use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (e.g., ephedrine). If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest.

If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted. The median lethal dose (LD 50 ) of Dyclonine HCl Topical Solution, USP administered orally to female rats is 176 mg/kg and 90 mg/kg in female mice. Intraperitoneally the LD 50 in female rats is 31 mg/kg and 43 mg/kg in female mice.

🧬 Clinical Pharmacology 38 words ▾

CLINICAL PHARMACOLOGY: Dyclonine HCl Topical Solution, USP effects surface anesthesia when applied topically to mucous membranes. Effective anesthesia varies with different patients, but usually occurs from 2 to 10 minutes after application and persists for approximately 30 minutes.

📦 How Supplied / Storage and Handling 62 words ▾

HOW SUPPLIED: Clear and colorless sterile solution, in one fluid ounce bottles. Multi dose Dyclonine HCl Topical Solution 0.5% (NDC 0362-3971-05) Dyclonine HCl Topical Solution 1% (NDC 0362-3918-10). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep upright and preserve in tight and light-resistant container. Avoid excessive heat (temperatures above 40ºC [104ºF]). Subject to damage by freezing.

📋 Description 66 words ▾

Description: DycloPro (Dyclonine Hydrochloride Topical Solution, USP, 0.5% and 1%) topical anesthetics contain a local anesthetic agent and are administered topically. See INDICATIONS for specific uses. DycloPro (Dyclonine Hydrochloride Topical Solution, USP, 0.5% and 1%) contain dyclonine HCl, which is chemically designated as 4’-butoxy-3-piperidinopropiophenone HCl.

Dyclonine HCl is a white crystalline powder that is sparingly soluble in water and has the following structural formula: Structural Formula

💬 Information for Patients 150 words ▾

Information for Patients: When topical anesthetics are used in the mouth or throat, the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, food should not be ingested for 60 minutes following use of local anesthetic preparations in the mouth or throat area. This is particularly important in children because of their frequency of eating.

Numbness of the tongue or buccal mucosa may increase the danger of biting trauma. When Dyclonine HCl Topical Solution, USP is used to relieve the pain of oral ulcers or stomatitis which interferes with eating, patients should be warned about the risk of biting trauma before they accept this treatment; caution should be exercised in selecting food and eating. Following other uses in the mouth and throat area, food and/or chewing gum should not be used while the area is anesthetized.

⚠️ Precautions 135 words ▾

PRECAUTIONS: General: The safety and effectiveness of dyclonine depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies (see WARNINGS and ADVERSE REACTIONS ). The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Repeated doses of dyclonine may cause significant increases in blood levels with each repeated dose because of slow accumulation of the drug or its metabolites.

Tolerance to elevated blood levels varies with the status of the patient. Debilitated, elderly patients, acutely ill patients and children should be given reduced doses commensurate with their age, weight and physical condition. Dyclonine should also be used with caution in patients with severe shock or heart block.

Dyclonine HCl Topical Solution, USP should be used with caution in persons with known drug sensitivities.

🍼 Nursing Mothers 34 words ▾

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dyclonine is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 40 words ▾

Carcinogenesis, mutagenesis, impairment of fertility: Long-term animal studies have not been performed to evaluate the potential mutagenic or carcinogenic potential of dyclonine hydrochloride. Likewise, animal studies to characterize the potential effects of dyclonine hydrochloride on fertility have not been completed.

📄 Package Label / Principal Display Panel 61 words ▾

Principal Display Panel - Carton - 0.5% NDC 0362-3971-05 DycloPro (Dyclonine Hydrochloride Topical Solution, USP, 0.5%) Topical Anesthetic 1FL.OZ. (30mL) NOT FOR INJECTION NOT FOR USE IN THE EYES. Rx only Multi dose Manufactured for SEPTODONT, Inc. 205 Granite Run Dr., Suite 150, Lancaster, PA, USA 17601 by Novocol Pharmaceutical of Canada, Inc. Ontario, Canada N1R 6X3 DycloPro_Dyclonine 0.5 (US) box

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

About this NDC listing & data coverage

Finished prescription 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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

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 Septodont Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Septodont 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 00362-1200-50 · Septodont, 00362-9011-50 · Septodont, →
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.