Breezers Cool Berry Pectin 7 mg Lozenge, 25-count
by Mondelez Global LLC · 25 LOZENGE in 1 BAG (12546-151-25)
NDC 12546-0151-25
🏷️ FDA NDC (as labeled)
12546-151-25
billing pads the product segment with a zero
This package
Contains25-count
Pack sizes2 compare ↓
Also comes in:
70 lozenges 12546-0151-70
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 →
🆔 Identity & classification
FDA NDC (as labeled)
12546-151-25
Product NDC
12546-151
11-digit billing NDC
12546015125
RxCUI
700897
UNII
89NA02M4RX
Application #
M022
SPL Set ID
b31d0078-21d7-4d18-a8d3-7c8d48d6d004
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2019-03-24
Route
ORAL
Dosage form
LOZENGE
Substance
PECTIN
Why two NDCs?
The FDA registers this code as 12546-151-25 — 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 → 12546-0151-25. 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 Other intestinal adsorbents class.
Drug family (ATC)
Other intestinal adsorbents
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
LabelerMondelez Global LLC
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code12546
First marketedMar 2019
Product typeHuman Otc Drug
Portfolio27 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
🧪 What is this product?
Breezers Cool Berry Pectin is an over-the-counter lozenge containing pectin, a soluble fiber derived from fruit. This product is marketed under the FDA's OTC monograph rules for antidiarrheal agents. Pectin is typically used to help reduce loose stools and is commonly found in throat lozenges and digestive products. The lozenge form allows the ingredient to be taken by mouth and dissolve slowly.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Pectin?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
red
ShapeOval
ImprintH
Size22 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 XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
-
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 L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
-
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 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
-
UNII 817L1N4CKP
Malic acid is a naturally occurring organic acid found in fruits. It works as a buffer and flavor agent to maintain the medicine's pH balance and add tartness to the product.
-
UNII EE90ONI6FF
Potassium citrate is a salt derived from citric acid and potassium. In medicines, it acts as a buffer to adjust and maintain the pH balance of the product, helping keep it stable and palatable.
-
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
-
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
-
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.
10 inactive ingredients listed in the exact product block matched to this NDC.
The official label also states<citric acid, FDC blue 2, FDC red 40, flavors, glucose syrup, malic acid, potassium citrate, soy lecithin, sucrose, titanium dioxide, 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.
💲 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 system | Per each | Per 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.
Try another pack size:
70 lozenges
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Breezers Cool Berry 7 mgthis 12546-0151-25 | Mondelez | 25 lozenges | — | — | FDA listed | — |
| Breezers Creamy Strawberry 7 mg 12546-0352-25 | Mondelez | 25 lozenges | — | — | FDA listed | — |
| Halls Breezers Sugar Free Cool Berry 7 mg 12546-0720-20 | Mondelez | 20 lozenges | — | — | FDA listed | — |
| Leader Throat Soothing Drops Creamy Strawberry 7 mg 70000-0711-01 | Cardinal | 30 lozenges | — | — | FDA listed | — |
| Cough Drops Dollar General Strawberry Flavor 25ct 7 mg 75712-0435-01 | Dollar | 225 lozenges | — | — | FDA listed | — |
| Cough Drops Dollar General Berries Flavor 25ct 7 mg 75712-0436-01 | Dollar | 225 lozenges | — | — | FDA listed | — |
| MGC Health Throat Soothing Drops Creamy Strawberry 7 mg 83173-0120-30 | Medical | 30 lozenges | — | — | FDA listed | — |
| Quality Choice Throat Soothing Drops Creamy Strawberry 7 mg 83324-0140-30 | Chain | 30 lozenges | — | — | FDA listed | — |
| MGC Health Throat Soothing Drops Creamy Strawberry 7 mg 83698-0120-30 | Xiamen | 30 lozenges | — | — | FDA listed | — |
| Quality Choice Throat Soothing Drops Creamy Strawberry 7 mg 83698-0626-30 | Xiamen | 30 lozenges | — | — | FDA listed | — |
| Leader Throat Soothing Drops Creamy Strawberry 7 mg 83698-0711-30 | Xiamen | 30 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
🏛️
2019
On the market since
Mar 2019
📍
2026
Currently FDA-listed
7 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.
🔬 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 Breezers Cool Berry (this brand).
Top reported reactions
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 12546-0151-25 You're viewing this | 25 LOZENGE in 1 BAG (12546-151-25) | 2019-03-24 | Active |
| 12546-0151-70 | 70 LOZENGE in 1 BAG (12546-151-70) | 2019-03-24 | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 12546-0151-25?
NDC 12546-0151-25 is a 25-count package — 25 lozenge in 1 bag.
What is the difference between NDC 12546-0151-25 and NDC 12546-0151-70?
Both are Breezers Cool Berry Pectin 7 mg Lozenge — the drug itself is identical. NDC 12546-0151-25 is the 25-count package, while NDC 12546-0151-70 is the 70 lozenges package.
What NDC number is used to bill for this package of Breezers Cool Berry Pectin 7 mg Lozenge?
Bill NDC 12546-0151-25 — the 11-digit billing format is 12546015125. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 FDA registers it as 12546-151-25, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 12546-0151-25, written without dashes as 12546015125. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 12546-0151-25, the first segment (12546) is the labeler code FDA assigned to Mondelez Global LLC; the middle segment (0151) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (25) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Mondelez Global LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 70 lozenges (12546-0151-70). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Mondelez Global LLC 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.
📄 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
🎯 Indications and Usage ▾
Uses <temporarily relieves the following symptoms associated with sore mouth and sore throat: minor discomfort irritated areas>
⏱️ Dosage and Administration ▾
Directions adults and children 5 years and over: dissolve 1 or 2 drops (one at a time) slowly in the mouth. Repeat as needed. children under 5 years, ask a doctor
⚠️ Warnings ▾
Warnings <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. These may be serious.>
🧪 Active Ingredient ▾
Active Ingredient <(per drop) Pectin 7 mg>
🧪 Inactive Ingredients ▾
Inactive ingredients <citric acid, FDC blue 2, FDC red 40, flavors, glucose syrup, malic acid, potassium citrate, soy lecithin, sucrose, titanium dioxide, water>
🎯 Purpose ▾
Purpose <Oral demulcent>
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.