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Fluoride Anticavity,Toothpaste .76 g Paste, Dentifrice, 1 tube — NDC 87576-0332-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Fluoride Anticavity,Toothpaste .76 g Paste, Dentifrice, 1 tube — NDC 87576-332-02 (Billing 87576-0332-02)

by Shulisa (Foshan) Daily ChemicalIndustry Co., Ltd · 1 TUBE in 1 BOX / 1 PASTE, DENTIFRICE in 1 TUBE

This is a package of 1 tube of Fluoride Anticavity,Toothpaste .76 g Paste, Dentifrice from Shulisa (Foshan) Daily ChemicalIndustry Co., Ltd, marketed since Apr 2026 and currently FDA-listed. It is this product's only package size.

NDC 87576-0332-02
🏷️ FDA NDC (as labeled) 87576-332-02 billing pads the product 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

NDC database record

One package, one record: these facts belong to NDC 87576-332-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
87576 labeler · 332 product · 02 package
Package marketed since
Apr 3, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8757633202 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 87576-332-02
Product NDC 87576-332
11-digit billing NDC 87576033202
RxCUI 545626
UNII C810JCZ56Q
SPL Set ID 4e912f10-64f2-d179-e063-6294a90a748d
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-03
Route DENTAL
Dosage form PASTE, DENTIFRICE
Substance SODIUM MONOFLUOROPHOSPHATE
Quick answers
  • RxCUI (RxNorm): 545626
Why two NDCs? The FDA registers this code as 87576-332-02 — 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 → 87576-0332-02. 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 Caries prophylactic agents class.

Drug family (ATC) Caries prophylactic agents, Fluoride
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 a toothpaste dentifrice applied topically to the teeth and mouth. It contains sodium monofluorophosphate, a fluoride compound typically used in oral care products to help reduce tooth decay. Fluoride functions by strengthening tooth enamel and is commonly included in over-the-counter dental products intended for regular brushing. This product listing appears without an approved FDA application.

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 gPer 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
87576-0332-02 You're viewing this Main listing 1 TUBE in 1 BOX / 1 PASTE, DENTIFRICE in 1 TUBE 2026-04-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
biotene 1.4 mg/g 00135-0577-01 Haleon 1 tube — — FDA listed —
Whitening .14 g/100g 11673-0385-09 Target 2 tubes — — FDA listed —
Kids Strawberry FTP .13 g/100g 11673-0441-01 Target 1 tube — — FDA listed —
Simple Truth Kids Flouride .76 g/100g 30142-0146-79 Kroger 119 g — — FDA listed —
Natural Adult Fluoride .76 g/100g 30142-0223-39 Kroger 1 tube — — FDA listed —
Colgate Revitalizing White 1 mg/g 35000-0017-46 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Cavity Protection Great Regular Flavor 1 mg/g 35000-0060-48 Colgate-Palmolive 1 tube — — FDA listed —
Hello Whipped Peppermint Stick Flavor 1.1 mg/g 35000-0512-10 Colgate-Palmolive 1 tube — — FDA listed —
Hello Whipped Mellow Mint Dream Flavor 1.1 mg/g 35000-0513-10 Colgate-Palmolive 1 tube — — FDA listed —
Hello Activated Charcoal 1.1 mg/g 35000-0678-10 Colgate-Palmolive 1 tube — — Discontinued —
Hello Naturally Whitening 1.1 mg/g 35000-0682-10 COLGATE 1 tube — — FDA listed —
Colgate Optic White Pro Series Stain Prevention 1.1 mg/g 35000-0747-16 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Optic White Stain Prevention 1 mg/g 35000-0893-43 Colgate-Palmolive 1 tube — — Discontinued —
COLGATE Great Regular Flavor 1 mg/g 35000-0913-01 Colgate-Palmolive 1 tube — — FDA listed —
ULTRA BRITE Baking Soda and Peroxide Whitening Cool Mint 1 mg/g 35000-0916-60 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Sparkling White Mint Zing 1 mg/g 35000-0919-46 Colgate-Palmolive 1 tube — — Discontinued —
COLGATE Baking Soda and Peroxide Whitening Brisk Mint 1 mg/g 35000-0959-46 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Optic White Platinum Stain-Less 1 mg/g 35000-0973-32 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Essentials 1 mg/g 35000-0974-46 Colgate-Palmolive 1 tube — — Discontinued —
Colgate Optic White Advanced Icy Fresh 1 mg/g 35000-0977-32 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Advanced Sparkling White 1 mg/g 35000-0978-14 Colgate-Palmolive 1 tube — — FDA listed —
Colgate Optic White Renewal High Impact White 1 mg/g 35000-0982-15 Colgate-Palmolive 1 tube — — Discontinued —
MediChoice Fluoride 7.6 mg/g 39892-0602-01 O&M 17 g — — FDA listed —
Natures Promise Childrens Fluoride Strawberry .13 g/100g 41520-0724-29 Foodhold 119 g — — FDA listed —
Charm Tex FLUORIDE .1 g/100g 42086-0051-01 Jiangsu 720 tubes — — FDA listed —
United Dental Kit 42509-0134-01 Wessco 1 kit — — FDA listed —
Colgate Anticavity 7.6 mg/g 42555-0060-45 Colgate-Palmolive 10 g — — FDA listed —
365 Everyday Value Cavity Fighting and Whitening .13 g/100g 42681-5002-09 Whole 1 tube — — Discontinued —
365 Everyday Value Kids Flouride .13 g/100g 42681-5276-09 Whole 119 g — — FDA listed —
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartar 1.4 mg/g 51009-0202-04 Tom's 1 tube — — FDA listed —
Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar 1.4 mg/g 51009-0203-04 Tom's 1 tube — — FDA listed —
Toms Wicked Fresh Cool Peppermint fresh breath / cavity protection 1.4 mg/g 51009-0205-47 Tom's 1 tube — — Discontinued —
Toms Wicked Fresh Spearmint Ice fresh breath / cavity protection 1.4 mg/g 51009-0206-47 Tom's 1 tube — — Discontinued —
Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR 1.4 mg/g 51009-0219-04 Tom's 1 tube — — FDA listed —
Toms Kids Watermelon Wiggle 1 mg/g 51009-0854-42 Tom's 119 g — — Discontinued —
Toms Of Maine Whole Care Spearmint 1 mg/g 51009-0857-69 Tom's 1 tube — — FDA listed —
Toms Of Maine Whole Care Spearmint 1 mg/g 51009-0858-69 Tom's 1 tube — — FDA listed —
Toms Of Maine Wicked Fresh Cool Peppermint 1 mg/g 51009-0859-07 Tom's 1 tube — — FDA listed —
Toms Of Maine Wicked Fresh Spearmint Ice 1 mg/g 51009-0860-07 Tom's 1 tube — — FDA listed —
Toms Of Maine Whole Care Wintermint 1 mg/g 51009-0902-40 Tom's 1 tube — — FDA listed —
Toms Of Maine Kids Silly Strawberry 1 mg/g 51009-0910-10 Tom's 1 tube — — Discontinued —
Toms Of Maine Kids Outrageous Orange Mango 1 mg/g 51009-0911-51 Tom's 144 g — — FDA listed —
Toms Of Maine Wicked Cool Mild Mint 1 mg/g 51009-0912-51 Tom's 144 g — — FDA listed —
Freshmint Anticavity Fluoride 7.6 mg/g 51824-0067-01 New 17 g — — FDA listed —
Anti Cavity Fluoride .76 g/100g 52000-0107-01 Universal 181 g — — FDA listed —
Advanced Whitening Anti Cavity Fluoride .76 g/100g 52000-0108-01 Universal 181 g — — FDA listed —
Universal Anti-Cavity Fluoride .76 g/100g 52000-0111-01 Universal 181 g — — FDA listed —
Universal Advanced Whitening Anti-Cavity Fluoride .76 g/100g 52000-0112-01 Universal 181 g — — FDA listed —
Medpride 7.6 mg/g 52410-9005-03 Shield 42.5 g — — FDA listed —
PERIOSCIENCES HYDRATING AO Pro 1.3 mg/mL 53238-0003-90 PERIOSCIENCES 1 tube — — FDA listed —
Nature Mint Anticavity 7.6 mg/g 53247-0129-01 Bob 7.94 g — — FDA listed —
Nature Mint Anticavity 7.6 mg/g 53247-0144-01 Bob 7.94 g — — Discontinued —
SparkleFresh Flouride Toothpaste 1 mg/g 53329-0083-21 Medline 42.5 g — — FDA listed —
Rexall Travel Toothbrush and Tooth-paste 55910-0087-01 Old 1 kit — — FDA listed —
Colgate Anticavity Kit 7.6 mg/g 56153-0001-05 Ming 1 tube — — FDA listed —
Colgate Anticavity Kit 7.6 mg/g 56153-0002-05 Ming 1 tube — — FDA listed —
First Class Kit 7.6 mg/g 58701-0001-10 American 1 tube — — FDA listed —
Business Class Kit 7.6 mg/g 58701-0002-10 American 1 tube — — FDA listed —
United Airlines Business Class Kit 7.6 mg/g 58733-0001-10 United 1 tube — — FDA listed —
smart way MINT cavity protection .13 g/100g 59450-0010-01 The 1 tube — — FDA listed —
AP-24 Whitening 7.6 mg/g 62839-1155-01 NSE 110 g — — FDA listed —
COLGATE Great Regular Flavor 1 mg/g 65954-0060-01 Mission 1 tube — — FDA listed —
Colgate ULTRA BRITE Baking Soda and Peroxide Whitening 1.1 mg/g 65954-0063-60 Mission 1 tube — — FDA listed —
Colgate Sparkling White Mint Zing 1 mg/g 65954-0068-48 Mission 1 tube — — FDA listed —
COLGATE Baking Soda and Peroxide Whitening Brisk Mint 1 mg/g 65954-0765-48 Mission 1 tube — — FDA listed —
Colgate Baking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint 1 mg/g 65954-0768-35 Mission 3 tubes — — FDA listed —
Colgate Optic White Platinum Stain-Less 1 mg/g 65954-0785-32 Mission 1 tube — — FDA listed —
Colgate Essentials 1 mg/g 65954-0786-46 Mission 1 tube — — FDA listed —
Colgate Great Regular Flavor 1 mg/g 67751-0118-01 Navajo 1 tube — — FDA listed —
Morning Fresh 76 mg/g 67777-0175-11 Dynarex 1 tube — — FDA listed —
Sodium Monofluorophosphate 760 mg/g 67777-0181-02 Dynarex 144 tubes — — FDA listed —
Morning Fresh Mint Toothpaste, with Fluoride 1.3 mg/mL 67777-0190-03 Dynarex 144 tubes — — FDA listed —
Fluoride .76 g/g 68599-9571-01 McKesson 1 g — — FDA listed —
Murchison Hume Dental Kit 69491-0034-01 Buzz 1 kit — — FDA listed —
Ipana Wintergreen Fluoride .1 g/100g 69510-0010-19 Maxill 1 tube — — FDA listed —
Ipana Bucky Beaver Bubble Gum Childrens Fluoride .1 g/100g 69510-0020-19 Maxill 1 tube — — FDA listed —
Listerine Essential Care 1.3 mg/g 69968-0701-04 Kenvue 1 tube — — FDA listed —
Brush Buddies Value 2 pack Whitening .76 g/100g 70108-0030-01 Ashtel 2 tubes — — FDA listed —
Brush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDE .15 g/100g 70108-0185-01 Ashtel 2 tubes — — FDA listed —
Charm Tex FLUORIDE .1 g/100g 71035-0001-01 Yangzhou 720 tubes — — FDA listed —
dentalux ANTI-CAVITY FLUORIDE .13 g/100g 71141-0186-10 Lidl 1 tube — — FDA listed —
Orazen .1 g/100g 71927-0102-01 Orazen 1 tube — — FDA listed —
Colgate 5g Toothbrush Kit 72845-0000-00 Wuhan 1 kit — — FDA listed —
Colgate Anticavity 73234-0040-00 MING 1 kit — — FDA listed —
Cloveden Tooth .76 g/100g 73242-1112-02 DONG 1 tube — — FDA listed —
White Glo Micellar 73656-0003-00 WHITE 1 kit — — FDA listed —
White Glo Bio-Enzyme 73656-0005-00 WHITE 1 kit — — FDA listed —
White Glo Professional Choice 73656-0007-00 WHITE 1 kit — — FDA listed —
White Glo Charcoal 73656-0009-00 WHITE 1 kit — — FDA listed —
White Glo Maximum White Charcoal 73656-0013-00 WHITE 1 kit — — FDA listed —
White Glo Instant White 73656-0015-00 WHITE 1 kit — — FDA listed —
White Glo Mouthwash Protection 73656-0017-00 WHITE 1 kit — — FDA listed —
White Glo Activated Charcoal Twin Pack 73656-0020-00 WHITE 1 kit — — FDA listed —
White Glo Professional Choice Twin Pack 73656-0024-00 WHITE 1 kit — — FDA listed —
White Glo Advantage Anticavity Fluoride Purple 7.6 mg/g 73656-0026-00 WHITE 1 tube — — FDA listed —
White Glo Advantage Anticavity Professional Whitening 7.6 mg/g 73656-0027-00 WHITE 1 tube — — FDA listed —
White Glo Instant White Blue Foam Optical Enhancers Fluoride Anticavity Value 2 pack and Toothbrush 73656-0028-00 WHITE 1 kit — — FDA listed —
White Glo Coffee and Tea Stain Remover Fluoride Anticavity 73656-0030-00 WHITE 1 kit — — FDA listed —
Optimax Anticavity Fluoride Watermelon 7.6 mg/g 73656-0032-00 WHITE 1 tube — — FDA listed —
Optimax Anticavity Fluoride Cotton Candy 7.6 mg/g 73656-0033-00 WHITE 1 tube — — FDA listed —
Optimax Purple Anticavity Fluoride 73656-0034-00 WHITE 1 kit — — FDA listed —
Optimax Professional Whitening Anticavity Fluoride 73656-0036-00 WHITE 1 kit — — FDA listed —
Optimax Professional Whitening Anticavity Fluoride 73656-0038-00 WHITE 1 kit — — FDA listed —
Optimax Purple Anticavity Fluoride 73656-0039-00 WHITE 1 kit — — FDA listed —
White Glo Charcoal Baking Soda Maximum White Fluoride Anticavity 73656-0041-00 White 1 kit — — FDA listed —
White Glo Coffee and Tea Stain Remover Fluoride Anticavity 73656-0042-00 White 1 kit — — FDA listed —
White Glo Professional Choice Fluoride Anticavity 7.6 mg/g 73656-0043-00 White 2 tubes — — FDA listed —
White Glo Mouthwash Protect Fluoride Anticavity 73656-0044-00 White 1 kit — — FDA listed —
White Glo Extreme White Whitening 7.6 mg/g 73656-0046-00 White 2 tubes — — FDA listed —
White Glo Purple Color Corrector Fluoride Anticavity 7.6 mg/g 73656-0047-00 White 2 tubes — — FDA listed —
Optimax Anticavity Fluoride Bubblegum 7.6 mg/g 73656-0048-00 White 1 tube — — FDA listed —
Optimax Anticavity Fluoride Raspberry 7.6 mg/g 73656-0049-00 White 1 tube — — FDA listed —
Freshen Up .76 g/100g 77782-0005-20 MKJ 2 bottles — — FDA listed —
Colgate Anticavity 79940-0010-00 FORMIA 1 kit — — FDA listed —
Colgate Anticavity 79940-0012-00 FORMIA 1 kit — — FDA listed —
Colgate Anticavity 79940-0013-00 FORMIA 1 kit — — FDA listed —
Coffe Tea Stain Remover Tooth .76 g/100g 82168-0001-01 Guangzhou 150 g — — FDA listed —
Instant Whitening .76 g/100g 82168-0002-01 Guangzhou 150 g — — FDA listed —
Professional Choice .76 g/100g 82168-0003-01 Guangzhou 150 g — — FDA listed —
Professional whitening tooth .76 g/100g 82168-0004-01 Guangzhou 100 g — — FDA listed —
purple tooth .76 g/100g 82168-0005-01 Guangzhou 100 g — — FDA listed —
Zohar Fluoride Anti Cavity Coolmint Flavour 7.6 mg/g 84045-0004-00 ZOHAR 1 tube — — Discontinued —
Zohar Fluoride Anti-Cavity Regular Mint Flavour 7.6 mg/g 84045-0005-00 ZOHAR 1 tube — — Discontinued —
Zohar Fluoride Anti Cavity Fresh Mint Flavor 7.6 mg/g 84045-0006-00 ZOHAR 1 tube — — Discontinued —
DeCure 7.6 mg/g 84132-0100-10 Scope 10 g — — FDA listed —
Carekon Anti-Cavity Fluoride .76 g/100g 84345-0086-01 Hunan 1 tube — — FDA listed —
Nature Mint Anti cavity Fluoride .1 g/100g 85891-0009-01 SPARROW 720 tubes — — Discontinued —
Fluoride Anticavity,Toothpaste .76 gthis 87576-0332-02 Shulisa 1 tube — — 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
Apr 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 4XYU5U00C4
    A synthetic colorant used to give medicines a dark color. It helps identify the product and makes tablets or capsules visually distinctive.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 6FO62KCQ7A
    Disodium hydrogen citrate is a salt derived from citric acid. It acts as a buffer to maintain the pH of the medicine and may also help improve the stability and taste of the product.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII 5EM498GW35
    A mixture of aromatic compounds used to add pleasant smell to the medicine. Fragrance helps mask unpleasant tastes or odors, making the medication easier to take.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII Y6O7T4G8P9
    Hydrated silica is a fine powder form of silicon dioxide with absorbed water. It works as an anti-caking agent and absorbent in medicines, helping powders stay free-flowing and preventing clumping.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII LAV5U5022Y
    Methyl salicylate is a naturally derived liquid compound commonly found in wintergreen plants. In medicines, it's used as a flavoring agent and penetrating solvent to help distribute active ingredients evenly throughout topical products.
  • UNII 1212Z7S33A
    PEG-32 is a synthetic polymer derived from ethylene oxide. It acts as a humectant and solvent in medications, helping to dissolve or suspend active ingredients and maintain moisture in solid dosage forms.
  • UNII N9H3ZTX0BG
    Phosphoric acid is a weak acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the medicine's stability and proper acidity level in liquid formulations.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII C3M81465G5
    Spearmint oil is a natural flavoring extract from spearmint plants. It's added to medicines to improve taste and mask bitter flavors, making medications easier to take.
  • UNII O352864B8Z
    A sodium salt compound used in medicines as a buffering agent to maintain pH stability and as a chelating agent to prevent unwanted chemical reactions during storage and mixing.
  • UNII 3J50XA376E
    Thymol is a natural compound derived from thyme and other plants. It acts as a preservative and flavoring agent in medicines, helping prevent microbial growth and add taste.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesWATER,SORBITOL,HYDRATED SILICA,GLYCERIN,PEG-32,SODIUM LAURYL SULFATE,CELLULOSE GUM,SODIUM SACCHARIN,EUCALYPTUS GLOBULUS LEAF OIL,METHYL SALICYLATE,THYMOL,PHOSPHORIC ACID,MENTHOLUM,Tetrasodium Pyrophosphate,XANTHAN GUM,SODIUM BENZOATE,Fragrance,Spearmint Leaf Oil,Disodium Hydrogen Phosphate,CARBON BLACK,IRON OXIDES

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

LabelerShulisa (Foshan) Daily ChemicalIndustry Co., Ltd
Labeler code87576
First marketedApr 2026
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from Shulisa (Foshan) Daily ChemicalIndustry Co., Ltd labeler code 87576

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 16 words ▾

It is recommended to brush your teeth after each meal or at least twice a day.

⏱️ Dosage and Administration 16 words ▾

It is recommended to brush your teeth after each meal or at least twice a day.

⚠️ Warnings 5 words ▾

keep out of reach child

🧪 Active Ingredient 2 words ▾

Sodium monofluorophosphate

🧪 Inactive Ingredients 20 words ▾

WATER,SORBITOL,HYDRATED SILICA,GLYCERIN,PEG-32,SODIUM LAURYL SULFATE,CELLULOSE GUM,SODIUM SACCHARIN,EUCALYPTUS GLOBULUS LEAF OIL,METHYL SALICYLATE,THYMOL,PHOSPHORIC ACID,MENTHOLUM,Tetrasodium Pyrophosphate,XANTHAN GUM,SODIUM BENZOATE,Fragrance,Spearmint Leaf Oil,Disodium Hydrogen Phosphate,CARBON BLACK,IRON OXIDES

🎯 Purpose 5 words ▾

Protect teeth, maintain oral hygiene

📄 Keep Out of Reach of Children 6 words ▾

keep out of reach of child

📄 Package Label / Principal Display Panel 1 words ▾

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Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 "Unapproved Drug Other". 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 Shulisa (Foshan) Daily ChemicalIndustry Co., Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Shulisa (Foshan) Daily ChemicalIndustry Co., Ltd 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.
← 87576-0112-01 · Shulisa 87579-0001-01 · Guangzhou →
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.