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Sootheez Watermelon Mint Pectin 11.5 mg/3.5g Lozenge, 49 g — NDC 61584-0020-01 package photo

Sootheez Watermelon Mint Pectin 11.5 mg/3.5g Lozenge, 49 g

by Primrose Candy Co. · 49 g in 1 CANISTER (61584-020-01)
NDC 61584-0020-01
🏷️ FDA NDC (as labeled) 61584-020-01 billing pads the product 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) 61584-020-01
Product NDC 61584-020
11-digit billing NDC 61584002001
RxCUI 2204565
UNII 89NA02M4RX
Application # M022
SPL Set ID 4e5e4342-4647-ef25-e063-6394a90a1d13
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-02
Route ORAL
Dosage form LOZENGE
Substance PECTIN
Why two NDCs? The FDA registers this code as 61584-020-01 — 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 → 61584-0020-01. 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 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

LabelerPrimrose Candy Co.
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code61584
First marketedFeb 2026
Product typeHuman Otc Drug
Portfolio4 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?

Sootheez Watermelon Mint is an over-the-counter lozenge that dissolves in the mouth and contains pectin as its active ingredient. Pectin is a soluble fiber commonly used in lozenges and throat products to form a soothing, protective layer in the mouth and throat. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for its category rather than individual approval. The lozenge format allows the pectin to coat the oral tissues as it dissolves.

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.

💊 What it looks like

Color red
ShapeOval
Size23 mm
FlavorWatermelon
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 9871T0PD5P
    Apple juice is a liquid extract from apples. It's used in medicines as a sweetener and flavoring agent to improve taste, and sometimes as a solvent or vehicle to help deliver the active ingredient.
  • UNII 3CCB416HVP
    A natural extract from bilberry fruit used as a colorant and flavoring agent. It adds purple-blue color and subtle fruit taste to medicines while serving no therapeutic function.
  • UNII QXF936IX43
    A liquid extract from carrots that adds color and natural flavor to medicines. It serves as a natural colorant and flavoring agent in tablets, capsules, and liquid formulations.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 6X543N684K
    A natural flavoring derived from grapes that enhances taste appeal. It's used in medicines to improve flavor and make medications more palatable, especially for children or patients who need better taste acceptance.
  • UNII Y9H1V576FH
    Honey is a natural sweetener made by bees from flower nectar. In medicines, it adds sweetness to improve taste and may help soothe throat irritation in lozenges or syrups.
  • UNII AGN709ANTJ
    A natural liquid extracted from lemons, containing citric acid and water. It's used as a flavoring agent and acidifying ingredient to enhance taste and help maintain the medicine's pH balance.
  • UNII FV98Z8GITP
    A natural flavoring from mint plants. It's added to medicines to mask bitter tastes and improve how the medicine tastes, making it easier to take.
  • UNII EM5RP35463
    A plant extract from radish root used as a natural flavoring agent and colorant in medicines. It adds taste and visual appeal to oral formulations like tablets and liquids.
  • UNII 4N14V5R27W
    A natural flavoring derived from raspberry fruit that gives medicines a pleasant taste. It helps mask bitter or unpleasant flavors to make medications easier to swallow.
  • 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 231473QB6R
    Watermelon is a fruit extract or flavoring agent. It's added to medicines to improve taste, making the product more palatable, especially for children or medications with unpleasant flavors.
  • UNII A195V20H7A
    White rice is a starchy grain used as a filler and binder in tablets and capsules. It helps give the medicine its solid form and allows other ingredients to mix evenly throughout the product.

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

The official label also statescitric acid organic apple juice concentrate organic cane sugar organic grape juice concentrate organic honey organic mint flavor organic raspberry powder organic rice syrup organic lemon juice concentrate organic vegetable juice concentrate (carrot, radish) organic watermelon flavor organic wildberry juice concentrate

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sootheez Berry Lemonade 11.5 mg/3.5g 61584-0017-01 Primrose 49 g — — FDA listed —
Sootheez Strawberry Lemonade 11.5 mg/3.5g 61584-0018-01 Primrose 49 g — — FDA listed —
Sootheez Birthday Cake 11.5 mg/3.5g 61584-0019-01 Primrose 49 g — — FDA listed —
Sootheez Watermelon Mint 11.5 mg/3.5gthis 61584-0020-01 Primrose 49 g — — FDA listed —
Lolleez Variety Pack 11.5 mg/7g 72427-3195-01 BFY 105 g — — FDA listed —
Lolleez Watermelon 11.5 mg/7g 72427-3295-01 BFY 105 g — — FDA listed —
Lolleez Strawberry 11.5 mg/7g 72427-3395-01 BFY 105 g — — FDA listed —
Lolleez Orange Mango 11.5 mg/7g 72427-3495-01 BFY 105 g — — FDA listed —
Lolleez Mixed Berry 11.5 mg/7g 72427-3515-01 BFY 105 g — — FDA listed —
Lolleez Organic Variety Pack (WM, SB, BC, MB) 11.5 mg/7g 72427-3640-01 BFY 280 g — — FDA listed —
Sootheez Organic Wild Cherry 11.5 mg/3.5g 72427-3714-00 BFY 13153 g — — FDA listed —
Sootheez Organic Raspberry 11.5 mg/3.5g 72427-3814-00 BFY 13153 g — — FDA listed —
Sootheez Berry Lemonade 11.5 mg/3.5g 72427-4014-00 BFY 13154 g — — FDA listed —
Sootheez Birthday Cake 11.5 mg/3.5g 72427-4114-00 BFY 13154 g — — FDA listed —
Sootheez Strawberry Lemonade 11.5 mg/3.5g 72427-4214-00 BFY 13154 g — — FDA listed —
Sootheez Watermelon Mint 11.5 mg/3.5g 72427-4314-00 BFY 13154 g — — FDA listed —
Lolleez Variety Pack 11.5 mg/7g 72427-4540-01 BFY 280 g — — FDA listed —
Lolleez Birthday Cake - Conventional 11.5 mg/7g 72427-4615-00 BFY 7140 g — — FDA listed —
Sootheez Organic Variety Pack 11.5 mg/3.5g 72427-4756-01 BFY 4 canisters — — 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

🏛️
2026
On the market since
Feb 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.

🔬 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 Sootheez Watermelon Mint (this brand).

Top reported reactions

Fatigue12
Nausea8
Abdominal Pain7
Cough7
Diarrhoea6
Headache6
Pyrexia6

Age at onset

Adult4
Elderly5

Reporter sex

76 reports
Male · 31%
Female · 69%

Serious outcomes

Hospitalization28
Life-threatening6
Death5
Disabling1
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 7 2
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 NDCDescription Marketing startStatus
61584-0020-01 You're viewing this 49 g in 1 CANISTER (61584-020-01) 2026-02-02 Active

🧭 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 61584-020-01, 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: 61584-0020-01, written without dashes as 61584002001. 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 61584-0020-01, the first segment (61584) is the labeler code FDA assigned to Primrose Candy Co.; the middle segment (0020) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Primrose Candy Co.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Primrose Candy Co. 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 11 words ▾

Uses Uses for temporary relief of minor discomfort of the throat.

⏱️ Dosage and Administration 38 words ▾

Directions Adukts and children 10 years of age and older: allow one drop to dissolve slowly in mouth May be repeated as needed or as directed by a doctor Children under 10 years of age: ask a doctor

⚠️ Warnings 87 words ▾

Warnings Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nuasea, or vomiting, consult a doctor promptly. If sore mouth symptoms, do not improve in 7 days, see your denist or doctor promptly. Stop use and ask a doctor if Stop use and ask a doctor if: sore throat does not improve in 7 days irritation, pain, or redness persists or worsens.

Keep out of reach of children Keep out of reach of children

📦 Storage and Handling 12 words ▾

Other information store in a dry place between 65-75F with in sealed.

🧪 Active Ingredient 4 words ▾

Active ingredient Pectin 11.5mg

🧪 Inactive Ingredients 43 words ▾

Inactive ingredients citric acid organic apple juice concentrate organic cane sugar organic grape juice concentrate organic honey organic mint flavor organic raspberry powder organic rice syrup organic lemon juice concentrate organic vegetable juice concentrate (carrot, radish) organic watermelon flavor organic wildberry juice concentrate

🎯 Purpose 3 words ▾

Purpose Oral Demulcent

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61584-0019-01 · Primrose 61589-0202-01 · BCM →
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.