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Sore Throat Logenzes Sore Throat Benzocaine and Menthol 15 mg; 3.6 mg Lozenge, 324-count

by Major Pharmaceuticals · 18 BLISTER PACK in 1 CARTON (0904-6255-49) / 18 LOZENGE in 1 BLISTER PACK
NDC 00904-6255-49
🏷️ FDA NDC (as labeled) 0904-6255-49 billing pads the labeler segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 0904-6255-49
Product NDC 0904-6255
11-digit billing NDC 00904625549
NCPDP billing unit EA — each (per item)
RxCUI 824574
UNII U3RSY48JW5, L7T10EIP3A
UPC 0309046255499
Application # M012
SPL Set ID 11416620-4892-44ba-9780-db27efff6743
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 2012-12-28
Route ORAL
Dosage form LOZENGE
Substance BENZOCAINE; MENTHOL
GPI-14 88359902154795
GPI class Sore Throat
GCN Seq No 067735
GCN 30354
HICL code 001675
Ingredient (HICL) Benzocaine/Menthol
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 SORE THROAT 15-3.6 MG LOZENGE
FDB brand name Sore Throat Lozenge
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0904-6255-49 — 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 → 00904-6255-49. 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.

🏭 Manufacturer & labeler

LabelerMajor Pharmaceuticals
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00904
First marketedDec 2012
Product typeHuman Otc Drug
Portfolio629 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.

🩺 Clinical

Label name SORE THROAT 15-3.6 MG LOZENGE Ingredient Benzocaine/Menthol
🧪 What is this product?

This is an over-the-counter lozenge containing benzocaine and menthol, marketed under FDA's monograph rules for sore throat products. Benzocaine is a local anesthetic typically used to numb pain and irritation in the mouth and throat. Menthol is a cooling agent commonly included to provide a soothing sensation and freshen breath. The lozenge is dissolved in the mouth to deliver these ingredients directly to the affected area.

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.

🧪 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 VI3D59RW0U
    Allyl sucrose is a modified sugar derivative used as a sweetener and flavoring agent in medicines. It makes the medication taste better to improve patient acceptance, particularly in liquid formulations or chewable tablets.
  • UNII 9G5L16BK6N
    A thick, sweet liquid made from corn starch. It acts as a sweetener, thickener, and binder in medicines, helping create the right texture and taste while holding ingredients together.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII A2M91M918C
    A plant-based oil derived from soybeans that has been chemically hardened to make it solid or semi-solid at room temperature. It acts as a binder, filler, and lubricant to help hold the tablet together and allow it to move smoothly during manufacturing and packaging.
  • 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 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.

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

The official label also statesGlucose syrup, N&A flavoring, propylene glycol, red #40, sucrose, and water. Soybean oil used as processing aid.

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.

💲 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 eaPer package
Retail pharmacies payNADAC · weekly $0.146 $47.17 / 324 lozenges
Medicaid paysCMS SDUD · 12 mo $0.4135 $133.97 / 324 lozenges
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jun 2022 Mar 2026 Aug 2026 $0.156 $0.085
▲ Up 63% over the last 16 months.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sore Throat Logenzes Sore Throat 15 mg/1; 3.6 mgthis 00904-6255-49 Major 324 lozenges $0.146 — Availability likely —
Cherry Sore Throat Lozenge 15 mg/1; 3.6 mg 00363-1079-18 Walgreens 18 lozenges — — FDA listed —
Sore Throat Logenzes Sore Throat 15 mg/1; 3.6 mg 17856-6255-01 ATLANTIC 50 lozenges — — FDA listed —
cherry throat relief lozenges 15 mg/1; 3.6 mg 35418-0010-18 Zee 18 lozenges — — FDA listed —
Cherry Sore Throat Lozenge 3.6 mg/1; 15 mg 36800-0832-18 TopCo 18 lozenges — — FDA listed —
Cherry Sore Throat Lozenges 15 mg/1; 3.6 mg 41250-0068-18 Meijer 18 lozenges — — FDA listed —
Cherry Sore Throat Lozenge 3.6 mg/1; 15 mg 41520-0043-18 American 18 lozenges — — FDA listed —
cherry throat relief lozenges 3.6 mg/1; 15 mg 42961-0401-18 Cintas 18 lozenges — — FDA listed —
Good Sense Cherry Benzocaine Lozenges 15 mg/1; 3.6 mg 50804-0025-18 Geiss, 18 lozenges — — FDA listed —
Cherry Sore Throat Lozenges 15 mg/1; 3.6 mg 52642-0036-18 Bestco 18 lozenges — — FDA listed —
cherry sore throat lozenge 3.6 mg/1; 15 mg 59779-0545-18 CVS 18 lozenges — — FDA listed —
Cepacol Extra Strength Sore Throat cherry 15 mg/1; 3.6 mg 63824-0713-04 Reckitt 4 lozenges — — Discontinued —
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

🏛️
2012
On the market since
Dec 2012
📍
2026
Currently FDA-listed
14 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00904-6255-49, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
5.1K
Units reimbursed last 4 qtrs
122.8K
Gross reimbursed last 4 qtrs
$50.8K
Avg / prescription
$9.98
Avg / unit
$0.4135
Latest quarter Q4 2025
1.1KRx
Medicaid pays / ea
$0.4135
gross reimbursed
vs
NADAC / ea
$0.1456
acquisition cost
=
Spread
+$0.2679
+184% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
89% MCO
Fee-for-service · 582 Rx Managed care · 4,505 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 346 units · 3.4 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 2,624 units · 82.2 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 637 units · 9.3 per 100k residents IN Ohio: 85,635 units · 727 per 100k residents OH Pennsylvania: 1,905 units · 14.7 per 100k residents PA New Jersey: 688 units · 7.4 per 100k residents NJ Massachusetts: 291 units · 4.2 per 100k residents MA California: 3,977 units · 10.2 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 4,053 units · 205 per 100k residents NE Missouri: no data reported MO Kentucky: 13,988 units · 309 per 100k residents KY West Virginia: no data reported WV Virginia: 1,494 units · 17.1 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 3,782 units · 50.9 per 100k residents AZ New Mexico: 2,334 units · 110 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: 546 units · 53.0 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: 467 units · 68.8 per 100k residents DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.4727
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Ohio 727 /100k
2 Kentucky 309 /100k
3 Nebraska 205 /100k
4 New Mexico 110 /100k
5 Nevada 82.2 /100k
6 D.C. 68.8 /100k
7 Delaware 53.0 /100k
8 Arizona 50.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00904-6255-49 You're viewing this 18 BLISTER PACK in 1 CARTON (0904-6255-49) / 18 LOZENGE in 1 BLISTER PACK 2012-12-28 Active

📄 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
🎯 Indications and Usage 17 words ▾

Uses temporary relief of occasional sore throat sore mouth minor mouth irritation pain associated with canker sores

⏱️ Dosage and Administration 41 words ▾

Directions adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist. children under 5 years of age: ask a doctor

⚠️ Warnings 139 words ▾

Warnings Allergy alert Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any 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, nausea or vomiting consult a doctor promptly. Do not use in a child under 5 years of age.

Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops If pregnant or breast-feeding, ask a health professional before use. Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not exceed recommended dosage.

📦 Storage and Handling 25 words ▾

Other information tamper evident packaging: Do not use if outer box or blister is open or damaged. store at room temperature protect contents from moisture

🧪 Active Ingredient 18 words ▾

Active ingredients (in each lozenge) Purpose Benzocaine 15 mg Oral pain reliever Menthol 3.6 mg Oral pain reliever

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients Glucose syrup, N&A flavoring, propylene glycol, red #40, sucrose, and water. Soybean oil used as processing aid.

🎯 Purpose 18 words ▾

Active ingredients (in each lozenge) Purpose Benzocaine 15 mg Oral pain reliever Menthol 3.6 mg Oral pain reliever

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00904-6221-06 · Major 00904-6269-08 · Major →
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.