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Benzocaine 20% 200 mg/mL Solution, 25 pouches — NDC 0121-1077-25 (Billing 00121-1077-25)

by PAI Holdings, LLC dba PAI Pharma · 25 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / .5 mL in 1 APPLICATOR

This is a package of 25 pouches of Benzocaine 20% 200 mg/mL Solution from PAI Holdings, LLC dba PAI Pharma, marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 00121-1077-25
🏷️ FDA NDC (as labeled) 0121-1077-25 billing pads the labeler 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) 0121-1077-25
Product NDC 0121-1077
11-digit billing NDC 00121107725
NCPDP billing unit EA — each (per item)
RxCUI 308657
UNII U3RSY48JW5
Application # M022
SPL Set ID 7fbce9a5-00dc-4a4a-8709-ab752bdf2f59
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 2026-03-20
Route TOPICAL
Dosage form SOLUTION
Substance BENZOCAINE

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

GCN Seq No 066834
GCN 29244
HICL code 001516
Ingredient (HICL) Benzocaine
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 BENZOCAINE 20% SPRAY
FDB brand name Benzocaine
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 066834
  • GCN: 29244
  • HICL (First Databank): 001516
  • AHFS class code: 52:16.00.00
  • RxCUI (RxNorm): 308657
Why two NDCs? The FDA registers this code as 0121-1077-25 — 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 → 00121-1077-25. 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 BENZOCAINE 20% SPRAY Ingredient Benzocaine
🧪 What is this product?

This is an over-the-counter topical solution containing benzocaine 20% that is marketed under FDA's OTC monograph rules for local anesthetics. Benzocaine is a numbing agent commonly used in topical products applied directly to the skin or mucous membranes to temporarily reduce pain or itching from minor cuts, sores, insect bites, or other small irritations. The solution form allows for easy application to affected areas.

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
00121-1077-25 You're viewing this Main listing 25 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / .5 mL in 1 APPLICATOR 2026-03-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Benzocaine 20% 200 mg/mLthis 00121-1077-25 PAI 25 pouches — — FDA listed —
HurriCaine Topical Anesthetic Liquid 200 mg/g 00283-0569-02 Beutlich 2 g — — Discontinued —
HurriCaine Topical Anesthetic Liquid 200 mg/g 00283-1886-17 Beutlich 1 g — — FDA listed —
Walgreens Mouth Sore Relief 200 mg/mL 00363-5334-00 Walgreens 1 bottle — — FDA listed —
Walgreens Maximum Strength 20 g/100g 00363-5820-58 Walgreens 1 bottle — — FDA listed —
Kank-A Mouth Pain 200 mg/mL 10157-9477-01 Blistex 9.75 ml — — FDA listed —
Red Cross Oral Pain Relief 200 mg/mL 10742-8902-01 The 1 bottle — — FDA listed —
Rite Aid Maximum Strength 20 g/100g 11822-0345-09 Rite 1 bottle — — FDA listed —
Rite Aid Professional Strength 20 g/100g 11822-5340-08 Rite 1 bottle — — FDA listed —
Topcare Maximum Strength 20 g/100g 36800-0443-48 Topco 1 bottle — — FDA listed —
Dental Relief 200 mg/g 42961-0810-03 Cintas 10 packets — — FDA listed —
Rexall Maximum Strength 20 g/100mL 55910-0346-79 Rexall 1 bottle — — FDA listed —
CVS Pharmacy Maximum Strength 20 g/100g 59779-0743-89 CVS 1 bottle — — FDA listed —
Mouth Sore Relief Professional Strength 200 mg/g 59779-0830-38 CVS 1 bottle — — FDA listed —
DenTek Instant Pain Relief Maximum Strength 200 mg/mL 60630-0078-01 DenTek 1 vial — — FDA listed —
Dental Relief 200 mg/g 68421-8100-03 Cintas 10 packets — — FDA listed —
Anesgerm LA MUELA Fast Pain Relief 200 mg/mL 73635-7101-05 Germa 1 bottle — — Discontinued —
Oral Anesthetic Liquid 20 g/100g 79481-0118-09 Meijer, 1 bottle — — FDA listed —
Anbesol Maximum Strength 200 mg/mL 80070-0230-41 Foundation 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

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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.

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

The official label also statesflavor, polyethylene glycol, 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

LabelerPAI Holdings, LLC dba PAI Pharma
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code00121
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio142 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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

Uses for the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat.

⏱️ Dosage and Administration 83 words ▾

Directions Read Directions on side panel for how to use adults and children 2 years of age and older apply to the affected area, Gargle, swish around in the mouth, or allow to remain in place for at least 15 seconds and then spit out. Use up to 4 times daily or as directed by a 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

⚠️ Warnings ~1 min read ▾

Warnings 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. Stop 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 if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentist or doctor promptly. Do not use for teething in children under 2 years of age When using this product avoid contact with eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a doctor or dentist Stop using and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops Keep out of reach of children.

If more than used for pain is accidently swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

📦 Storage and Handling 16 words ▾

Other information do not use if foil pouch is torn or open store at 15-30°C (59-86°F)

🧪 Active Ingredient 4 words ▾

Active Ingredient Benzocaine 20%

🧪 Inactive Ingredients 6 words ▾

Inactive ingredients flavor, polyethylene glycol, sucralose

🎯 Purpose 3 words ▾

Purpose Oral Anesthetic

📄 Do Not Use 12 words ▾

Do not use for teething in children under 2 years of age

📄 When Using This Product 28 words ▾

When using this product avoid contact with eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a doctor or dentist

📄 Stop Use and Ask a Doctor If 28 words ▾

Stop using and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops

📄 Keep Out of Reach of Children 26 words ▾

Keep out of reach of children. If more than used for pain is accidently swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

📄 Questions or Comments 39 words ▾

Questions or comments? call 1-800-845-8210 *This product is not manufactured or distributed by Beutlich Pharmaceuticals. LLC, the distributor of HurriCaine ONE®, and owner of the registered trademark HurriCaine ONE®, [Beutlich Pharmaceuticals, LLC does not make or license PAI's product.]

📄 Package Label / Principal Display Panel 214 words ▾

Principal Display Panel - pouch NDC 0121- 1077 -01 BENZOCAINE 20% SOLUTION Individually Wrapped Single-Unit Dose Applicator 20% Benzocaine Oral Anesthetic CHERRY FLAVOR Store at 15° - 30°C (59 - 86°F) Warnings 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 the blood. This can occur even if you have used this product before. stop use and seek immediate medical attention if you or your 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" anesthetics.

Please refer to Drug Facts for complete product information. 1 Single-Unit Dose Applicator 0.017 fl oz (0.5 mL) Benzocaine pouch

Principal Display Panel - carton NDC 0121- 1077 -25 PAI Pharma Compare to the active ingredient in HurriCaine ONE® BENZOCAINE 20% SOLUTION Individually Wrapped Single-Unit Dose Applicator 20% Benzocaine Oral Anesthetic CHERRY FLAVOR 25 Single-Unit Dose Applicators 0.017 fl. oz. (0.5 mL) EACH 0.425 fl. oz (12.5 mL) TOTAL Benzocaine carton

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 Benzocaine 20% — the ingredient across all brands.

Top reported reactions

Dyspnoea5
Oxygen Saturation Decreased4
Application Site Erythema3
Cyanosis3
Injection Site Swelling3
Injection Site Ulcer3
Methaemoglobinaemia3

Reporter sex

0 reports

Serious outcomes

Life-threatening3
Disabling1
Reports over time (by year) — tap or hover for the count & year
2025 2026 6 0
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 — Not published for this NDC No photo available yet for this listing.
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 PAI Holdings, LLC dba PAI Pharma. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PAI Holdings, LLC dba PAI Pharma 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.
← 00121-1076-00 · PAI 00121-1091-55 · PAI →
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.