Home › NDC Lookup › Ingredients › Benzocaine › 00363-1113-18
Walgreens Mixed Berry Benz-Dex Lozenges Benzocaine 7.5 mg; 5 mg Lozenge, 18-count — NDC 00363-1113-18 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Walgreens Mixed Berry Benz-Dex Lozenges Benzocaine 7.5 mg; 5 mg Lozenge, 18-count — NDC 0363-1113-18 (Billing 00363-1113-18)

by Walgreen · 18 LOZENGE in 1 BLISTER PACK

This is a package of 18 lozenges of Walgreens Mixed Berry Benz-Dex Lozenges Benzocaine 7.5 mg; 5 mg Lozenge from Walgreen, marketed since Jun 2022 and currently FDA-listed. It is this product's only package size.

NDC 00363-1113-18
🏷️ FDA NDC (as labeled) 0363-1113-18 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 0363-1113-18 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0363 labeler · 1113 product · 18 package
Package marketed since
Jun 9, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0311917136585
FDA record last changed
Oct 8, 2026
⚠️
Other active recalls for Benzocaine (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0602-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0605-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0601-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0603-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0604-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0606-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0363-1113-18
Product NDC 0363-1113
11-digit billing NDC 00363111318
RxCUI 1039251
UNII U3RSY48JW5, 9D2RTI9KYH
UPC 0311917136585
Application # M012
SPL Set ID e108731f-6b77-225a-e053-2a95a90ac25c
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 2022-06-09
Route ORAL
Dosage form LOZENGE
Substance BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE
Quick answers
  • RxCUI (RxNorm): 1039251
Why two NDCs? The FDA registers this code as 0363-1113-18 — 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 → 00363-1113-18. 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

🧪 What is this product?

This is an over-the-counter lozenge marketed under the OTC monograph rule. It contains benzocaine, a local anesthetic commonly used in lozenges to numb minor mouth and throat discomfort, and dextromethorphan hydrobromide, an ingredient typically used to help suppress cough. The mixed berry flavor is added for taste. This product is intended to be dissolved slowly in the mouth.

Supplement & herbal interactions

Some supplements/herbs that may interact with Benzocaine — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Benzocaine (3 interactions) — ranked by severity →
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 eachPer 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
00363-1113-18 You're viewing this Main listing 18 LOZENGE in 1 BLISTER PACK 2022-06-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cepacol Extra Strength Sore Throat and Cough 5 mg/1; 7.5 mg 63824-0744-16 Reckitt 16 lozenges $0.151 — FDA listed —
Walgreens Mixed Berry Benz-Dex Lozenges 7.5 mg/1; 5 mgthis 00363-1113-18 Walgreen 18 lozenges — — FDA listed —
Mixed Berry Sore Throat Lozenges 7.5 mg/1; 5 mg 36800-0836-18 Topco 18 lozenges — — FDA listed —
Mixed Berry Sore Throat and Cough Lozenges 7.5 mg/1; 5 mg 37808-0062-18 HEB 18 lozenges — — FDA listed —
Mixed Berry Sore Throat and Cough lozenge 7.5 mg/1; 5 mg 41250-0066-18 Meijer 18 lozenges — — FDA listed —
Mixed Berry Throat and Cough Lozenges 7.5 mg/1; 5 mg 69842-0377-18 CVS 18 lozenges — — FDA listed —
Equate Benz-Dex Cough and Throat Lozenges 7.5 mg/1; 5 mg 79903-0042-18 Walmart 18 lozenges — — 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

🏛️
2022
On the market since
Jun 2022
📍
2026
Currently FDA-listed
4 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 red
ShapeRound
ImprintB
Size17 mm
ScoringNot scored
FlavorBerry
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 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.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesInactive ingredients: Acesulfame potassium, corn starch, corn syrup, FD&C Blue 1, FD&C Red 40, glycerin, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose and water.

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

LabelerWalgreen
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00363
First marketedJun 2022
Product typeHuman Otc Drug
Portfolio9 products on file

More NDCs from Walgreen labeler code 00363

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 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 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 29 words ▾

Uses temporarily relieves these symptoms: occasional minor mouth irritation, sore mouth and sore throat cough due to minor throat and bronchial irritation as may occur with the common cold

⏱️ Dosage and Administration 89 words ▾

Directions adults and children 12 years and older - Allow 2 lozenges to dissolve slowly in mouth, one at a time; may be repeated every 4 hours, not to exceed 12 lozenges in 24 hours, or as directed by a doctor children 6 to 12 years of age - take 1 lozenge and allow to dissolve slowly in mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor children under 6 years of age - do not use

⚠️ Warnings 132 words ▾

Warnings Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a 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 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 persist or worsens, see your dentist or doctor promptly.

🆘 Overdosage 14 words ▾

In case of overdose, get medical help or contact Poison Control Center right away.

🧪 Active Ingredient 12 words ▾

Active ingredients (in each lozenge) Benzocaine 7.5 mg Dextromethorphan hydrobromide 5 mg

🧪 Inactive Ingredients 29 words ▾

Inactive ingredients: Acesulfame potassium, corn starch, corn syrup, FD&C Blue 1, FD&C Red 40, glycerin, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose and water.

🎯 Purpose 6 words ▾

Purposes Oral Pain Reliever Cough Suppressant

📄 Do Not Use 90 words ▾

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. Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, as a doctor or pharmacist before taking this product. for teething in children under 2 years of age

📄 Ask a Doctor Before Use If 28 words ▾

Ask a doctor before use if you have: persistent of chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)

📄 Stop Use and Ask a Doctor If 48 words ▾

Stop use and ask doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling develops cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

🤰 If Pregnant or Breast-Feeding 11 words ▾

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

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Other Information 9 words ▾

Other information store at room temperature protect from moisture

📄 Questions or Comments 17 words ▾

Questions? Or to report an adverse event call 1-800-245-2898 , Monday through Friday, 9AM to 4PM EST

📄 Package Label / Principal Display Panel 5 words ▾

Walgreens Mixed Berry Benz-Dex 18ct

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 — the ingredient across all brands.

Top reported reactions

Methaemoglobinaemia175
Dyspnoea103
Nausea84
Drug Hypersensitivity75
Asthenia74
Pain74
Vomiting65

Age at onset

Neonate7
Infant3
Child6
Adolescent4
Adult128
Elderly59

Reporter sex

1,507 reports
Male · 37%
Female · 63%
Unknown · 1%

Serious outcomes

Hospitalization583
Life-threatening184
Death135
Disabling73
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 129 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 ✓ 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 Walgreen. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Walgreen 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.
← 00363-1110-22 · Walgreen 00363-1130-07 · Walgreen →
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.