Home › NDC Lookup › Ingredients › Benzocaine, Menthol, Zinc Chloride › 65852-0015-01
Giltuss Bucalsep Benzocaine, Menthol, Zinc chloride .12 mg/100mL; 6.5 mg/100mL; .1 mg/100mL Spray — NDC 65852-0015-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Giltuss Bucalsep Benzocaine, Menthol, Zinc chloride .12 mg/100mL; 6.5 mg/100mL; .1 mg/100mL Spray — NDC 65852-015-01 (Billing 65852-0015-01)

by Dextrum Laboratories Inc. · 1 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC

This is a package of Giltuss Bucalsep Benzocaine, Menthol, Zinc chloride .12 mg/100mL; 6.5 mg/100mL; .1 mg/100mL Spray from Dextrum Laboratories Inc., marketed since Jul 2018 and currently FDA-listed. It is this product's only package size.

NDC 65852-0015-01
🏷️ FDA NDC (as labeled) 65852-015-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 65852-015-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
65852 labeler · 015 product · 01 package
Package marketed since
Jul 26, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6585201501 6
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65852-015-01
Product NDC 65852-015
11-digit billing NDC 65852001501
UNII 13S1S8SF37, U3RSY48JW5, L7T10EIP3A
Application # M022
SPL Set ID 3fa233dc-156c-1e95-e063-6294a90a8bbd
Established class (EPC) Copper Absorption Inhibitor; Standardized Chemical Allergen
Physiologic effect Decreased Copper Ion Absorption; Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-07-26
Route ORAL, TOPICAL
Dosage form SPRAY
Substance ZINC CATION; BENZOCAINE; MENTHOL
Why two NDCs? The FDA registers this code as 65852-015-01 — 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 → 65852-0015-01. 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?

Giltuss Bucalsep is an over-the-counter spray product applied to the mouth and throat. It contains benzocaine, a local anesthetic commonly used to numb pain and irritation in the mouth and throat, along with menthol, which produces a cooling sensation and is often used for similar comfort purposes. Zinc chloride is included as a mild astringent. This is an OTC monograph drug, meaning it is marketed under FDA's established rules for this category of product rather than as an individually approved application.

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
65852-0015-01 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC 2018-07-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Giltuss Bucalsep .12 mg/100mL; 6.5 mg/100mL; .1 mg/100mLthis 65852-0015-01 Dextrum 1 bottle — — 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

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 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.

What it looks like

FlavorSpearmint
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 D9OM4SK49P
    Cetylpyridinium chloride is a chemical compound that acts as a preservative and antimicrobial agent in medicines. It helps prevent bacterial growth and extends the shelf life of liquid formulations.
  • 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 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 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

The official label also statesInactive ingredients Cetylpyridinium chloride, glycerin, Methylparaben, Proylene Glycol, Propylparaben, Purified Water, Spearmint Flavor and Sucralose.

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

LabelerDextrum Laboratories Inc.
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code65852
First marketedJul 2018
Product typeHuman Otc Drug
Portfolio11 products on file

More NDCs from Dextrum Laboratories Inc. labeler code 65852

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 79 words ▾

Indication and usage section Indication and usage section Adults and children 2 years of age and older apply to affected area gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out use 4 times daily or as directed by dentist or doctor children under 12 years of age should be supervised in the use of the product Children under 2 years of age: do not use indication an user

⏱️ Dosage and Administration 71 words ▾

Directions Directions: Adults and children 2 years of age and older apply to affected area gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out use 4 times daily or as directed by dentist or doctor children under 12 years of age should be supervised in the use of the product Children under 2 years of age: do not use Directions

⚠️ Warnings 157 words ▾

Warnings Warnings Do not use IN OR NEAR THE EYES. In the event of accidental contact with the eyes, flush immediately and continuosly for 10 minutes. Seek immediate medical attention if pain or irritations persists. this product for more than 7 days unless directed by a doctor or a dentist Methemoglobinemia Warning: use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood.

This can occur even if you have used this product before.Stopo use and seek immediate medical attention if you or a child in your care develops: pale, gray or blue colored skin ( cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetic Allergy alert Warnings

🧪 Active Ingredient 20 words ▾

Active Ingredients Active ingredients Purpose Benzocaine, 6.5% ----------------- Anesthesic Menthol, 0.1% ----------------------- Anesthesic Zinc Chloride 0.12% --------------- Astringent Active ingredients

🧪 Inactive Ingredients 19 words ▾

Inactive Ingredients Inactive ingredients Cetylpyridinium chloride, glycerin, Methylparaben, Proylene Glycol, Propylparaben, Purified Water, Spearmint Flavor and Sucralose. Inactive ingredients

🎯 Purpose 27 words ▾

Uses Uses temporary relieves pain due to the following mouth and gum irritations sore mouth and throat canker sores minor dental procedures dentures or orthodontic appliance Uses

📄 Do Not Use 30 words ▾

Do not use Do not use for teething in children under 2 years of age for more than 7 days unless directed by a dentist or doctor Do not use

📄 When Using This Product 29 words ▾

When using this product When using this product do not exceed recommended dosage avoid contact with eyes. In case of eye contact, rinse with water When using this product

📄 Stop Use and Ask a Doctor If 63 words ▾

Stop use and ask a doctor if Stop use and ask a doctor if Sore throat is severe, persist for more than 2 days, is accompanied, or followed by fever, headache, rash,nausea or vomiting Symptoms do not improve in 7 days irritation, pain or redness persist or worsen swelling, rash or fever develops Stop use and ask a doctor Stop use and ask

🤰 If Pregnant or Breast-Feeding 16 words ▾

If pregnant or breastfeeding If pregnant or breastfeeding, ask a health professional before use If pregnant

📄 Keep Out of Reach of Children 33 words ▾

Keep out of reach of children Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away Keep out of reach of children

📄 Other Information 10 words ▾

Other information Other information Store at room temperature Other Information

📄 Questions or Comments 29 words ▾

Questions or comments? Questions or Comments? Questions or comments? Call 1-787-848-9114, Monday-Friday 9AM – 5PM EST Call your doctor for medical advice in the event of side effects. Questions

📄 Package Label / Principal Display Panel 26 words ▾

NDC: 58552-135-01 Alcohol free Oral Spray Giltuss Bucalsep Sore, Throat, Oral astringent 1 floz (30 mL) Alcohol free, sugar free, dye free Spearmint flavor Active ingredients

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

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 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 Dextrum Laboratories Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Dextrum Laboratories 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.
← 65852-0013-06 · Dextrum 65852-0016-04 · Dextrum →
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.