Home › NDC Lookup › Ingredients › Benzocaine, Menthol, Zinc Chloride › 58552-0135-01
Giltuss Bucalsep Benzocaine, Menthol, Zinc chloride 6.5 g/100mL; .1 g/100mL; .12 g/100mL Spray — NDC 58552-0135-01 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 6.5 g/100mL; .1 g/100mL; .12 g/100mL Spray — NDC 58552-135-01 (Billing 58552-0135-01)

by Gil Pharmaceutical Corp · 1 BOTTLE, SPRAY in 1 CARTON / 30 mL in 1 BOTTLE, SPRAY

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

NDC 58552-0135-01
🏷️ FDA NDC (as labeled) 58552-135-01 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 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58552-135-01
Product NDC 58552-135
11-digit billing NDC 58552013501
NCPDP billing unit ML — per mL (volume)
RxCUI 2170427
UNII U3RSY48JW5, L7T10EIP3A, 86Q357L16B
Application # M022
SPL Set ID 85053391-8d71-ab4f-e053-2991aa0a7e08
Established class (EPC) Standardized Chemical Allergen
Physiologic effect 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 BENZOCAINE; MENTHOL; ZINC CHLORIDE

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

GPI-14 88359903230920
GPI class Giltuss Bucalsep
GCN Seq No 080924
GCN 47912
HICL code 046243
Ingredient (HICL) Benzocaine/Menthol/Zinc Chlor
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H0
Therapeutic class — intermediate (HIC2) Act On Non-Autonomic Nervous System
HIC3 code H0A
Therapeutic class — specific (HIC3) Local Anesthetics
AHFS code 52:16.00.00
AHFS class Local Anesthetics (Eent)
FDB label name GILTUSS BUCALSEP SPRAY
FDB brand name Giltuss Bucalsep
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 080924
  • GCN: 47912
  • GPI-14 (Medi-Span): 88359903230920
  • HICL (First Databank): 046243
  • AHFS class code: 52:16.00.00
  • RxCUI (RxNorm): 2170427
Why two NDCs? The FDA registers this code as 58552-135-01 — 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 → 58552-0135-01. 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.

RxNorm drug class

This medicine belongs to the Standardized Chemical Allergen class.

Pharmacologic class Standardized Chemical Allergen
Drug family (ATC) Local anesthetics, Anesthetics for topical use, Esters of aminobenzoic acid
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 GILTUSS BUCALSEP SPRAY Ingredient Benzocaine/Menthol/Zinc Chlor
🧪 What is this product?

Giltuss Bucalsep is an over-the-counter oral spray marketed under FDA's monograph rules for oral and topical use. It contains benzocaine, a local anesthetic, and menthol, a cooling agent, both commonly used to numb and soothe minor mouth and throat discomfort. Zinc chloride is included as an astringent to help reduce irritation in the oral cavity. This product is intended for temporary relief of minor sore throat or mouth pain.

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
58552-0135-01 You're viewing this Main listing 1 BOTTLE, SPRAY in 1 CARTON / 30 mL in 1 BOTTLE, SPRAY 2018-07-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Giltuss Bucalsep 6.5 g/100mL; .1 g/100mL; .12 g/100mLthis 58552-0135-01 Gil 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

Color yellow
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 J7I2T6IV1N
    Spearmint is a plant-derived flavoring agent added to medicines to improve taste. It helps mask bitter or unpleasant flavors, making the medication easier to take.
  • 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.

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

The official label also statesInactive ingredients: Cetylpyridinium chloride, Spearmint Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, 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

LabelerGil Pharmaceutical Corp
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code58552
First marketedJul 2018
Product typeHuman Otc Drug
Portfolio31 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.

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 📄 Do Not Use 📄 Ask a Doctor or Pharmacist Before Use If 📄 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 49 words ▾

Uses for the temporary relief of occasional minor irritations, pain, sore mouth, sore throat, pain associated with canker sores, pain due to minor irritation or injury of the mouth and gums, pain due to dental procedures, pain due to minor irritations caused by dentures or orthodontic appliances, sore gums

⏱️ Dosage and Administration 97 words ▾

Directions Adults and children 2 years of age and older: Spray Giltuss Bucalsep several times to affected areas in the mouth or lips or as directed by a doctor or dentist use as a gargle or mouthwash gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out use up to 4 times daily or as directed by a doctor or dentist Children under 12 years of age: should be supervised in the use of this product Children under 2 years of age: consult a dentist or doctor

⚠️ Warnings 167 words ▾

Warnings Do not use IN OR NEAR THE EYES. In the event of accidental contact with the eyes, flush immediately and continuously for 10 minutes. Seek immediate medical attention if pain or irritation persists this product for more than 7 days unless directed by a doctor or a dentist Ask a doctor or pharmacist before use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics When using this product, do not exceed recommended dosage Stop use and ask a doctor or dentist if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea, or vomiting symptoms do not improve in 7 days irritation, pain or redness persists or increases, or a rash appears on the skin If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

📦 Storage and Handling 18 words ▾

Other information Tamper evident: Do not use if safety seal is broken or missing Store at room temperature

🧪 Active Ingredient 19 words ▾

Active ingredients (in each 30 mL) Benzocaine, 6.5% (1950 mg) Zinc Chloride, 0.12% (36 mg) Menthol, 0.1% (30 mg)

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients: Cetylpyridinium chloride, Spearmint Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sucralose

🎯 Purpose 4 words ▾

Purposes Anesthetic Astringent Anesthetic

📄 Do Not Use 48 words ▾

Do not use IN OR NEAR THE EYES. In the event of accidental contact with the eyes, flush immediately and continuously for 10 minutes. Seek immediate medical attention if pain or irritation persists this product for more than 7 days unless directed by a doctor or a dentist

📄 Ask a Doctor or Pharmacist Before Use If 26 words ▾

Ask a doctor or pharmacist before use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

📄 When Using This Product 9 words ▾

When using this product, do not exceed recommended dosage

📄 Stop Use and Ask a Doctor If 52 words ▾

Stop use and ask a doctor or dentist if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea, or vomiting symptoms do not improve in 7 days irritation, pain or redness persists or increases, or a rash appears on the skin

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

📄 Questions or Comments 27 words ▾

Questions or Comments? Call 1-800-848-9114 , Mon. - Fri. 9:00 a.m. thru 5:00 p.m. EST. Call your doctor for medical advice in the event of side effects.

📄 Package Label / Principal Display Panel 37 words ▾

MAXIMUM STRENGTH Oral Spray Giltuss BUCALSEP® SORE THROAT AND ORAL INFECTIONS ALCOHOL FREE. SUGAR FREE. DYE FREE RELIEVES SORE THROAT THROAT INFECTION CANKER SORES OTHER ORAL PAINS AND INJURIES SPEARMINT FLAVOR 1FL OZ (30 mL) 58552-135 Bucalsep

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 Gil Pharmaceutical Corp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Gil Pharmaceutical Corp 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.
← 58552-0134-04 · Gil 58552-0136-04 · Giltuss →
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.