HomeNDC LookupIngredientsSodium Fluoride › 37808-0163-77
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(from DailyMed)

Anticavity Fluoride Rinse SODIUM .1 mg/mL Mouthwash, 500 mL

by H E B · 500 mL in 1 BOTTLE, PLASTIC (37808-163-77)
NDC 37808-0163-77
🏷️ FDA NDC (as labeled) 37808-163-77 billing pads the product segment with a zero
This package
Contains500 mL Pack sizes2 compare ↓
Also comes in: 1000 ml 37808-0163-86
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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 →
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 37808-163-77
Product NDC 37808-163
11-digit billing NDC 37808016377
RxCUI 313029
UNII 8ZYQ1474W7
Application # M021
SPL Set ID 87327a36-a314-4daa-83b6-b4bd3e26bba2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2010-09-29
Route ORAL
Dosage form MOUTHWASH
Substance SODIUM FLUORIDE
Why two NDCs? The FDA registers this code as 37808-163-77 — 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 → 37808-0163-77. 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.

🏭 Manufacturer & labeler

LabelerH E B
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code37808
First marketedSep 2010
Product typeHuman Otc Drug
Portfolio264 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?

This is an over-the-counter mouthwash rinse that contains sodium fluoride at a concentration of 0.1 mg/mL. Sodium fluoride is commonly used in dental products to help strengthen tooth enamel and reduce cavity formation. This product is marketed under FDA's OTC monograph rules for anticavity rinses, meaning it follows established safety and effectiveness guidelines for this category rather than undergoing individual product review.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.
Try another pack size: 1000 ml
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
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride 2 mg/10mL 00126-0032-46 Colgate 500 ml FDA listed
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride 2 mg/10mL 00126-0034-46 Colgate 500 ml FDA listed
Anticavity .1 mg/mL 00363-0171-86 Walgreen 1000 ml Discontinued
Anticavity Fluoride Rinse .1 mg/mL 11673-0163-86 Target 1000 ml FDA listed
Anticavity .2 mg/mL 11822-9718-06 Rite 1000 ml FDA listed
Anticavity .2 mg/mL 30142-0163-86 The 1000 ml FDA listed
Alcohol-Free Anticavity .1 mg/mL 30142-0482-86 The 1000 ml FDA listed
Colgate Kids Unicorn Alcohol Free .1 mg/mL 35000-0334-84 Colgate-Palmolive 500 ml FDA listed
Colgate Enamel Strength Mouthwash .1 mg/mL 35000-0734-98 Colgate-Palmolive 500 ml FDA listed
Alcohol-Free Anticavity .1 mg/mL 36800-0482-86 Topco 1000 ml FDA listed
Anticavity .1 mg/mL 36800-0803-43 Topco 474 ml FDA listed
Anticavity .1 mg/mL 36800-0971-86 Topco 1000 ml FDA listed
Kids Crest Bubblegum Rush .1 mg/mL 37000-0167-05 The 500 ml FDA listed
Crest Pro-Health Advanced w/Extra Whitening .1 mg/mL 37000-0867-01 The 473 ml FDA listed
Anticavity .1 mg/mL 37808-0119-86 H 1000 ml FDA listed
Anticavity Fluoride Rinse .1 mg/mLthis 37808-0163-77 H 500 ml Discontinued
Anticavity .1 mg/mL 37808-0435-45 H 946 ml FDA listed
Alcohol Free Refreshing Mint .1 mg/mL 37808-0576-86 H 1000 ml FDA listed
Alcohol-Free Anticavity .1 mg/mL 37808-0942-86 H 1000 ml FDA listed
Anticavity .1 mg/mL 41163-0011-45 United 946 ml FDA listed
Anticavity .2 mg/mL 41163-0581-86 United 1000 ml FDA listed
Anticavity .1 mg/mL 41163-0971-86 United 1000 ml FDA listed
Act Total Care Anticavity Fluoride Fresh Mint .09 mg/mL 41167-0943-03 Chattem, 1000 ml FDA listed
ACT Total Care Anticavity Fluoride Icy Clean Mint .09 mg/mL 41167-0966-07 Chattem, 1000 ml FDA listed
ACT Total Care Dry Mouth Anticavity Mouth .09 mg/mL 41167-0968-00 Chattem, 532 ml FDA listed
ACT Restoring Anticavity Fluoride Mint Burst .2 mg/mL 41167-0978-01 Chattem, 30 ml FDA listed
ACT Restoring Anticavity Fluoride Cool Mint .09 mg/mL 41167-0981-07 Chattem, 1000 ml FDA listed
ACT Whitening Anticavity Gentle Mint .09 mg/mL 41167-0983-02 Chattem, 500 ml FDA listed
Anticavity .2 mg/mL 41250-0163-86 Meijer, 1000 ml FDA listed
Alcohol-Free Anticavity .1 mg/mL 41250-0482-86 Meijer, 1000 ml FDA listed
Oral Antivavity .1 mg/mL 41250-0576-86 Meijer, 1000 ml FDA listed
Anticavity .2 mg/mL 41250-0581-86 Meijer, 1000 ml FDA listed
Anticavity .1 mg/mL 41250-0971-86 Meijer, 1000 ml FDA listed
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity .1 mg/mL 42681-0048-01 WHOLE 500 ml FDA listed
Anticavity .1 mg/mL 49035-0163-86 Walmart 1000 ml FDA listed
Anticavity .2 mg/mL 49035-0581-86 Walmart 1000 ml FDA listed
Anticavity .1 mg/mL 49035-0971-86 Walmart 1000 ml FDA listed
Toms Whole Care Mouthwash Fresh Mint 1 mg/10mL 51009-0837-52 Tom's 473 ml FDA listed
Anticavity .2 mg/mL 53942-0163-86 Demoulas 1000 ml FDA listed
Glowing White .1 mg/mL 53942-0435-45 Demoulas 946 ml FDA listed
Sodium fluoride .2 mg/mL 53942-0581-86 Demoulas 1000 ml FDA listed
Anticavity .1 mg/mL 53942-0971-86 Demoulas 1000 ml FDA listed
Anticavity .1 mg/mL 55301-0435-43 Your 473 ml FDA listed
Alcohol-Free Anticavity .1 mg/mL 55301-0482-86 Your 1000 ml FDA listed
Anticavity Fluoride Rinse .1 mg/mL 55319-0163-86 Family 1000 ml FDA listed
Anticavity .1 mg/mL 55910-0163-86 Old 1000 ml Discontinued
Anticavity .1 mg/mL 55910-0971-86 Old 1000 ml FDA listed
Anticavity Fluoride Rinse .1 mg/mL 56062-0163-86 Publix 1000 ml FDA listed
Anticavity .1 mg/mL 56062-0435-43 Publix 474 ml Discontinued
Anticavity .1 mg/mL 56062-0971-86 Publix 1000 ml FDA listed
Plaque Refresh Remineralizing Rinse Fresh Mint .1 mg/mL 57660-0003-01 TJA 473 ml Discontinued
CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse .02 g/100mL 58578-0517-01 Rowpar 1 bottle FDA listed
Anticavity .1 mg/mL 59450-0971-86 The 1000 ml FDA listed
Crest Pro-Health Advanced Complete Care Anticavity Fluoride .1 mg/mL 69423-0751-01 The 1000 ml FDA listed
Crest 3D White Brilliance Pro Rinse .1 mg/mL 69423-0838-32 The 946 ml FDA listed
Crest Braces Care Anticavity Fluoride Rinse .1 mg/mL 69423-0881-16 The 475 ml FDA listed
Crest Pro Health Densify Rinse .1 mg/mL 69423-0882-32 The 946 ml FDA listed
Kids Crest Strawberry Rush .1 mg/mL 69423-0895-16 The 500 ml FDA listed
Anticavity .1 mg/mL 69842-0548-86 CVS 1000 ml FDA listed
sodium fluoride rinse .1 mg/mL 69892-0971-86 Rockland 1000 ml FDA listed
Listerine Total Care Fresh Mint Anticavity .1 mg/mL 69968-0178-01 Kenvue 250 ml Discontinued
Listerine Total Care Zero Alcohol Anticavity Fresh Mint .1 mg/mL 69968-0194-01 Kenvue 1000 ml FDA listed
Listerine Smart Rinse Berry Splash .1 mg/mL 69968-0606-03 Kenvue 27 ml FDA listed
Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash .1 mg/mL 69968-0687-05 Kenvue 500 ml FDA listed
Listerine Smart Rinse Anticavity Fluoride Rinse - Mint Shield .1 mg/mL 69968-0689-05 Kenvue 500 ml FDA listed
Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble Blast .1 mg/mL 69968-0690-05 Kenvue 500 ml FDA listed
Listerine Smart Rinse Anticavity Fluoride Rinse - Pink Lemonade Flavor .1 mg/mL 69968-0691-05 Kenvue 500 ml Discontinued
Listerine Total Care Fresh Mint Anticavity Fluoride .1 mg/mL 69968-0787-01 Kenvue 1000 ml FDA listed
Listerine Clinical Solutions Teeth Strength Alpine Mint .1 mg/mL 69968-0819-01 Kenvue 1000 ml FDA listed
Listerine Clinical Solutions Enamel Strength Alpine Mint .1 mg/mL 69968-0881-01 Kenvue 1000 ml FDA listed
Listerine Total Care Kids Anticavity Fluoride Rinse Mint Shield .1 mg/mL 69968-0902-05 Kenvue 500 ml FDA listed
Listerine Total Care Kids Anticavity Fluoride Rinse Bubble Blast .1 mg/mL 69968-0903-05 Kenvue 500 ml FDA listed
Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash .1 mg/mL 69968-0904-03 Kenvue 27 ml FDA listed
Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mint .1 mg/mL 69968-0924-01 Kenvue 1000 ml FDA listed
Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash .1 mg/mL 69968-0950-01 Kenvue 1000 ml FDA listed
Listerine Total Care Mild Alcohol Free Anticavity Fluoride Mouthwash .1 mg/mL 69968-0951-01 Kenvue 1000 ml FDA listed
Listerine Total Care Intense Anticavity Fluoride Mouthwash .1 mg/mL 69968-0952-01 Kenvue 1000 ml FDA listed
Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR .02 g/100mL 70108-0088-01 Ashtel 355 ml FDA listed
Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR .02 g/100mL 70108-0089-01 Ashtel 355 ml FDA listed
Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVOR .02 g/100mL 70108-0090-01 Ashtel 355 ml FDA listed
Anticavity Fluoride Rinse .1 mg/mL 71141-0159-32 Lidl 1000 ml FDA listed
Oral Antivavity .1 mg/mL 72036-0576-86 HARRIS 1000 ml FDA listed
Anticavity .2 mg/mL 72288-0439-43 Amazon.com 473 ml FDA listed
Alcohol-Free Anticavity .1 mg/mL 72288-0482-86 Amazon.com 1000 ml FDA listed
Oral Antivavity .1 mg/mL 72288-0576-86 Amazon.com 1000 ml FDA listed
Anticavity .1 mg/mL 72476-0005-86 ADUSA 1000 ml FDA listed
Anticavity .1 mg/mL 72476-0435-43 ADUSA 473 ml FDA listed
Alcohol-Free Anticavity .1 mg/mL 72476-0482-86 Retail 1000 ml FDA listed
Anticavity .2 mg/mL 72476-0971-86 Retail 1000 ml FDA listed
Brush Buddies Crayola Anticavity Fluoride Watermelon .02 g/100mL 73928-0041-01 Kingkey 355 ml Discontinued
Brush Buddies Crayola Anticavity Fluoride Strawberry .02 g/100mL 73928-0042-01 Kingkey 355 ml Discontinued
Brush Buddies Crayola Anticavity Fluoride Bubblegum .02 g/100mL 73928-0043-01 Kingkey 355 ml Discontinued
Oral Antivavity .1 mg/mL 76162-0576-86 Topco 1000 ml FDA listed
Alcohol-Free Anticavity .1 mg/mL 79903-0279-10 Walmart 1000 ml FDA listed
Dentalclean Doctor Duck Kids Flouride Mouthwash .1 mg/mL 84035-0010-20 Rabbit 600 ml FDA listed
Dentalclean Dr. Duck Strawberry flouride Mouthwash .1 mg/mL 84035-0011-20 Rabbit 600 ml FDA listed
Crest Pro-Health Advanced Multi-Protection .1 mg/mL 84126-0600-02 The 2 bottles FDA listed
Crest Deep Cleanse Cavity Defense .1 mg/mL 84126-0607-16 The 475 ml FDA listed
Crest Pro-Health Mouthwash Multi-Protection Strong Mint .1 mg/mL 84126-0647-01 The 1000 ml FDA listed
Crest Pro-Health Multi-Protection plus Extra Whitening .1 mg/mL 84126-0651-01 The 946 ml FDA listed
Crest 3D White Strength Whitening Enamel Protection .1 mg/mL 84126-0652-16 The 946 ml FDA listed
Anticavity mouth rinse Low-foaming Spearmint .02 g/100mL 87649-7180-01 Dyson 400 ml FDA listed
Anticavity .1 mg/mL 55301-0163-86 Your 1000 ml FDA listed
Anticavity .1 mg/mL 41163-0043-86 United 1000 ml FDA listed
Mouth Rinse .1 mg/mL 36800-0001-86 Topco 1000 ml FDA listed
Anticavity Fluoride Rinse .1 mg/mL 59779-0163-77 CVS 500 ml Discontinued
Mouth Rinse .1 mg/mL 00363-0163-86 Walgreen 1000 ml FDA listed
Crest 3D White Luxe Diamond Strong .1 mg/mL 37000-0862-01 The 473 ml 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

🏛️
2010
On the market since
Sep 2010
📍
2026
Currently FDA-listed
16 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 Anticavity Fluoride Rinse (this brand).

Top reported reactions

Pyrexia172
Weight Increased162
Nausea160
Vomiting159
Fatigue158
Pain158
Nasopharyngitis155

Age at onset

Child16
Adolescent6
Adult74
Elderly77

Reporter sex

1,067 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization379
Life-threatening84
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 213 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
37808-0163-77 You're viewing this 500 mL in 1 BOTTLE, PLASTIC (37808-163-77) 2010-09-29 Discontinued by firm
37808-0163-86 1000 mL in 1 BOTTLE, PLASTIC (37808-163-86) 2010-09-29 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 37808-0163-77?
NDC 37808-0163-77 contains 500 mL — 500 ml in 1 bottle, plastic.
What is the difference between NDC 37808-0163-77 and NDC 37808-0163-86?
Both are Anticavity Fluoride Rinse SODIUM .1 mg/mL Mouthwash — the drug itself is identical. NDC 37808-0163-77 is the 500 mL package, while NDC 37808-0163-86 is the 1000 ml package.
What NDC number is used to bill for this package of Anticavity Fluoride Rinse SODIUM .1 mg/mL Mouthwash?
Bill NDC 37808-0163-77 — the 11-digit billing format is 37808016377. 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 No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 37808-163-77, 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: 37808-0163-77, written without dashes as 37808016377. 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 37808-0163-77, the first segment (37808) is the labeler code FDA assigned to H E B; the middle segment (0163) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (77) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1000 ml (37808-0163-86). 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?
H E B 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 8 words

Use aids in the prevention of dental cavities

⏱️ Dosage and Administration 87 words

Directions Adults and children 6 years of age and older: use twice daily after brushing your teeth with toothpaste vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children under 6 years of age: consult a dentist or doctor

⚠️ Warnings 4 words

Warnings For this product

🤒 Adverse Reactions 58 words

ADVERSE REACTION MADE WITH PRIDE AND CARE FOR H-E-B ® SAN ANTONIO, TX 78204 H-E-B ® 100% GUARANTEE promise If you aren't completely pleased with this product, we'll be happy to replace it or refund your money. You have our word on it. DSP-TN-21091 DSP-MO-20087 PLASTIC BOTTLE US ONLY Widely Recyclable Discard Seal, Empty & Replace Cap how2recycle.info

🧪 Active Ingredient 9 words

Active ingredient Sodium fluoride 0.02% (0.01% w/v fluoride ion)

🧪 Inactive Ingredients 26 words

Inactive ingredients water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

🎯 Purpose 2 words

Purpose Anticavity

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.