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Brush Buddies DISNEY PRINCESS ANTICAVITY FLUORIDE - Grand Grape Sodium .05 g/100mL Mouthwash, 355 mL — NDC 70108-319-01 (Billing 70108-0319-01)

by Ashtel Studios Inc. · 355 mL in 1 BOTTLE, PLASTIC

This is a package of 355 mL of Brush Buddies DISNEY PRINCESS ANTICAVITY FLUORIDE - Grand Grape Sodium .05 g/100mL Mouthwash from Ashtel Studios Inc., marketed since Jan 2026 and currently FDA-listed. It is this product's only package size.

NDC 70108-0319-01
🏷️ FDA NDC (as labeled) 70108-319-01 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70108-319-01
Product NDC 70108-319
11-digit billing NDC 70108031901
RxCUI 240698
UNII 8ZYQ1474W7
UPC 0810147889686
Application # M021
SPL Set ID 6c6d143f-4c2b-4207-bde7-9df8251616a3
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-16
Route ORAL
Dosage form MOUTHWASH
Substance SODIUM FLUORIDE
Quick answers
  • RxCUI (RxNorm): 240698
Why two NDCs? The FDA registers this code as 70108-319-01 — 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 → 70108-0319-01. 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 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?

Brush Buddies Disney Princess Anticavity Fluoride is an over-the-counter mouthwash containing sodium fluoride, which is typically used to help strengthen tooth enamel and reduce cavity formation. This oral rinse product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for its category rather than undergoing individual product review. Sodium fluoride in mouthwash formulations is commonly included in oral hygiene products designed to support dental health when used as directed.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70108-0319-01 You're viewing this Main listing 355 mL in 1 BOTTLE, PLASTIC 2026-01-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint .5 mg/mL 00135-0449-01 Haleon 500 ml — — FDA listed —
SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh .5 mg/mL 00135-0451-01 Haleon 500 ml — — FDA listed —
TheraBreath for Kids Anticavity Wacky Watermelon .5 mg/mL 10237-0255-10 Church 296 ml — — FDA listed —
TheraBreath for Kids Anticavity Strawberry Splash .5 mg/mL 10237-0256-10 Church 296 ml — — FDA listed —
Therabreath Overnight Chamomile Mint 5 mg/10mL 10237-0262-16 Church 473 ml — — FDA listed —
TheraBreath AM-PM Twin Pack 10237-0268-01 Church 1 kit — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 11344-0004-44 Nice-Pak 532 ml — — FDA listed —
Anticavity .2 mg/mL 11673-0004-77 Target 500 ml — — FDA listed —
Fluoride Mouth Rinse Anticavity .2 mg/mL 11673-0213-44 Target 532 ml — — FDA listed —
Anticavity Rinse .5 mg/mL 11822-4004-04 Rite 532 ml — — FDA listed —
Anticavity .2 mg/mL 30142-0004-77 The 500 ml — — FDA listed —
Hello Wild Strawberry .02 g/100mL 35000-0685-10 Colgate-Palmolive 473 ml — — Discontinued —
Hello Unicorn Splash unicorn splash anticavity fluoride rinse .02 g/100mL 35000-0687-10 Colgate-Palmolive 473 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 36800-0004-44 Topco 532 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 36800-0213-44 Topco 532 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 37808-0213-44 H 532 ml — — FDA listed —
Anticavity Rinse .2 mg/mL 37808-0808-44 H 532 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 41163-0213-44 United 532 ml — — FDA listed —
ACT Kids Pure Protect Anticavity- Simply Strawberry .5 mg/mL 41167-0915-00 Chattem, 500 ml — — FDA listed —
ACT Anticavity Fluoride Arctic Blast .2 mg/mL 41167-0937-02 Chattem, 532 ml — — FDA listed —
ACT Kids Anticavity Fluoride Wild Watermelon .5 mg/mL 41167-0938-01 Chattem, 500 ml — — FDA listed —
ACT Anticavity Fluoride Cinnamon .2 mg/mL 41167-0940-08 Chattem, 532 ml — — FDA listed —
ACT Anticavity Fluoride Mint .2 mg/mL 41167-0942-01 Chattem, 30 ml — — FDA listed —
ACT Anticavity Fluoride Kids Bubblegum .2 mg/mL 41167-0944-01 Chattem, 30 ml — — FDA listed —
ACT Anticavity Fluoride Kids Groovy Grape .2 mg/mL 41167-0945-00 Chattem, 500 ml — — FDA listed —
ACT Kids Anticavity Fluoride Pineapple Punch .2 mg/mL 41167-0953-05 Chattem, 500 ml — — FDA listed —
ACT Restoring Anticavity Fluoride Cool Mint .2 mg/mL 41167-0957-05 Chattem, 532 ml — — FDA listed —
ACT Total Care Anticavity Fluoride Fresh Mint .2 mg/mL 41167-0961-00 Chattem, 532 ml — — FDA listed —
ACT Total Care Anticavity Fluoride Icy Clean Mint .2 mg/mL 41167-0965-00 Chattem, 532 ml — — FDA listed —
ACT Kids Berry Blast .5 mg/mL 41167-0976-00 Chattem, 500 ml — — FDA listed —
ACT Restoring Anticavity Fluoride Mint Burst .5 mg/mL 41167-0979-00 Chattem, 532 ml — — Discontinued —
Anticavity Rinse .2 mg/mL 41250-0004-44 Meijer, 532 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 41250-0213-44 Meijer, 532 ml — — FDA listed —
Anticavity Rinse .2 mg/mL 49035-0004-44 Walmart 532 ml — — FDA listed —
Anticavity Rinse .2 mg/mL 53942-0004-44 Demoulas 532 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 53942-0213-44 Demoulas 532 ml — — FDA listed —
Kids Flouride Rinse .2 mg/mL 55301-0004-44 Your 532 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 55301-0213-44 Your 532 ml — — FDA listed —
Anticavity Rinse .2 mg/mL 55319-0004-44 Family 532 ml — — FDA listed —
Anticavity .2 mg/mL 55910-0030-77 Old 500 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 59779-0004-77 CVS 500 ml — — FDA listed —
Anticavity .2 mg/mL 59779-0213-44 CVS 532 ml — — FDA listed —
Maintenance Rinse Mint 226 ug/mL 61578-0311-01 Dental 473 ml — — FDA listed —
Maintenance Rinse Citrus 226 ug/mL 61578-0312-01 Dental 473 ml — — FDA listed —
Maintenance Rinse Grape 226 ug/mL 61578-0313-01 Dental 473 ml — — FDA listed —
Treatment Rinse Mint 226 ug/mL 61578-0314-01 DENTAL 2 bottles — — FDA listed —
Treatment Rinse Apple 226 ug/mL 61578-0315-01 DENTAL 2 bottles — — FDA listed —
Cavity Protection Fresh Mint Anticavity Mouthwash .5 mg/mL 63615-0001-01 Oxyfresh 473 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 63941-0170-44 Valu 532 ml — — FDA listed —
Anticavity Rinse .2 mg/mL 63941-0904-77 Valu 500 ml — — FDA listed —
Firefly Anticavity Fluoride .5 mg/mL 66923-0003-34 Ranir 237 ml — — Discontinued —
Firefly Anticavity Fluoride .5 mg/mL 66923-0007-00 Ranir 473 ml — — FDA listed —
Firefly Anticavity Fluoride .5 mg/mL 66923-0111-43 Ranir 473 ml — — FDA listed —
PerCara Kids Bubble Gum .05 g/100mL 67933-0016-01 LEC 532 ml — — FDA listed —
Quip Anticavity Fluoride Concentrate .05 g/100mL 69261-0005-03 Quip 117.5 ml — — FDA listed —
Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR .05 g/100mL 70108-0091-01 Ashtel 355 ml — — FDA listed —
Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR .05 g/100mL 70108-0092-01 Ashtel 355 ml — — FDA listed —
Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVOR .05 g/100mL 70108-0093-01 Ashtel 355 ml — — FDA listed —
Brush Buddies Barbie ANTICAVITY FLUORIDE - Bubble Gum Flavor .05 g/100mL 70108-0094-01 Ashtel 355 ml — — FDA listed —
Brush Buddies Hot Wheels ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR .05 g/100mL 70108-0095-01 Ashtel 355 ml — — FDA listed —
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVOR .05 g/100mL 70108-0103-01 Ashtel 355 ml — — FDA listed —
Brush Buddies Oral Rinse Sparkle Mint .2 mg/mL 70108-0206-01 ASHTEL 473 ml — — FDA listed —
evo SENSITIVE WHITENING ANTI-CAVITY FLUORIDE .05 g/100mL 70108-0210-01 Ashtel 296 ml — — FDA listed —
Brush Buddies STAR WARS ANTICAVITY FLUORIDE - Saber Strike Strawberry .05 g/100mL 70108-0314-01 Ashtel 355 ml — — FDA listed —
Brush Buddies TOY STORY ANTICAVITY FLUORIDE - WILD WEST WATERMELON .05 g/100mL 70108-0315-01 Ashtel 355 ml — — FDA listed —
Brush Buddies SPIDEY and his AMAZING FRIENDS ANTICAVITY FLUORIDE-Spidey Punch .05 g/100mL 70108-0316-01 Ashtel 355 ml — — FDA listed —
Brush Buddies DISNEY FROZEN ANTICAVITY FLUORIDE - Blizzard Berry .05 g/100mL 70108-0317-01 Ashtel 355 ml — — FDA listed —
Brush Buddies Cars ANTICAVITY FLUORIDE - KA-CHOW CHERRY .05 g/100mL 70108-0318-01 Ashtel 355 ml — — FDA listed —
Brush Buddies DISNEY PRINCESS ANTICAVITY FLUORIDE - Grand Grape .05 g/100mLthis 70108-0319-01 Ashtel 355 ml — — FDA listed —
GuruNanda Anti-Cavity .2 mg/mL 70708-0890-16 GURUNANDA, 473 ml — — FDA listed —
GuruNanda Anticavity .2 mg/mL 70708-0927-16 GURUNANDA, 499 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 72036-0213-44 HARRIS 532 ml — — FDA listed —
Anticavity Rinse .2 mg/mL 72288-0004-77 Amazon.com 500 ml — — Discontinued —
Anticavity Fluoride Rinse .2 mg/mL 72288-0213-44 Amazon.com 532 ml — — FDA listed —
Anticavity Rinse .2 mg/mL 72476-0204-44 Retail 532 ml — — FDA listed —
Anticavity Fluoride Rinse .2 mg/mL 72476-0213-44 Retail 532 ml — — FDA listed —
EverSmile Squirt .05 g/100mL 72655-0702-01 Everbrands, 100 ml — — FDA listed —
Cool sense Care Plus .05 g/100mL 73242-1121-01 DONG 250 ml — — FDA listed —
Brush Buddies Crayola Anticavity Fluoride Strawberry .05 g/100mL 73928-0033-01 Kingkey 355 ml — — Discontinued —
Brush Buddies Crayola Anticavity Fluoride Watermelon .05 g/100mL 73928-0036-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Crayola Anticavity Fluoride Bubblegum .05 g/100mL 73928-0037-01 Kingkey 355 ml — — Discontinued —
Brush Buddies Crayola Anticavity Fluoride Strawberry .05 g/100mL 73928-0038-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Brbie Anticavity Fluoride Bubblegum .05 g/100mL 73928-0039-01 Kingkey 355 ml — — Discontinued —
Brush Buddies Crayola Anticavity Fluoride Strawberry .05 g/100mL 73928-0046-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Crayola Anticavity Fluoride Strawberry .05 g/100mL 73928-0047-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Brbie Anticavity Fluoride Bubblegum .05 g/100mL 73928-0048-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Squishmallows Anticavity Fluoride Mint Falvor .05 g/100mL 73928-0050-01 Kingkey 355 ml — — FDA listed —
Evo Sensitive Whitening Anti-cavity Fluoride Mouthwash .05 g/100mL 73928-0051-01 Kingkey 296 ml — — FDA listed —
Brush Buddies Mouthwash 12oz Star Wars Saber Strike Strawberry .05 g/100mL 73928-0130-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Mouthwash Disney Cars Chow Cherry .05 g/100mL 73928-0131-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Mouthwash Frozen Blizzard Berry .05 g/100mL 73928-0132-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Mouthwash Disney Princesses Grand Grape .05 g/100mL 73928-0133-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Mouthwash Spidey and Hist Amazing Friends Peter Parker Punch .05 g/100mL 73928-0134-01 Kingkey 355 ml — — FDA listed —
Brush Buddies Mouthwash Toy Story Wild West Watermelon .05 g/100mL 73928-0135-01 Kingkey 355 ml — — FDA listed —
Anticavity fluoride rinse .2 mg/mL 76162-0838-38 Topco 296 ml — — FDA listed —
Cool sense Care Plus .05 g/100mL 76670-0013-01 DOCSMEDI 250 ml — — FDA listed —
Anticavity Rinse .2 mg/mL 79481-0201-01 Meijer, 532 ml — — FDA listed —
Anticavity fluoride rinse .2 mg/mL 79481-0838-01 Meijer, 296 ml — — FDA listed —
Anticavity .2 mg/mL 79903-0033-44 Walmart 532 ml — — FDA listed —
Target Up And Up Anticavity .05 g/100mL 82442-0106-16 TARGET 473 ml — — FDA listed —
Dentalclean Blue Diamond Alcohol Free Mouthwash .2 mg/mL 84035-0009-01 Rabbit 1000 ml — — FDA listed —
Dentalclean Green Diamond Alcohol Free Mouthwash .2 mg/mL 84035-0012-20 Rabbit 1000 ml — — FDA listed —
Zohar Anti Cavity Mouthwash Coolmint Flavour .2 mg/mL 84045-0001-00 ZOHAR 500 ml — — Discontinued —
Zohar Anti Cavity Mouthwash Bubble Gum Flavour .2 mg/mL 84045-0002-00 ZOHAR 250 ml — — Discontinued —
Zohar Anti Cavity Mouthwash Fresh Mint Flavour .2 mg/mL 84045-0003-00 ZOHAR 500 ml — — Discontinued —
CloSYS Fluoride Rinse .05 g/100mL 58578-1234-01 Rowpar 1 bottle — — 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
Jan 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.

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.

Manufacturer & labeler

LabelerAshtel Studios Inc.
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code70108
First marketedJan 2026
Product typeHuman Otc Drug
Portfolio39 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.

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 6 words ▾

Uses helps protect teeth against cavities.

⏱️ Dosage and Administration 94 words ▾

Directions Adults and children 6 years of age and older: • Use once a day after brushing your teeth with a toothpaste. • Vigorously swish 10 milliliters 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 30 words ▾

Warnings Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for rinsing, call professional help at 1-800-222-1222 or go to PoisonHelp.org.

🧪 Active Ingredient 9 words ▾

Active ingredient Sodium fluoride 0.05% (0.02% w/v fluoride ion)

🧪 Inactive Ingredients 29 words ▾

Inactive ingredients Water, Sorbitol, Glycerin, Sodium Benzoate, PEG-40 Hydrogenated Castor Oil, PEG-400, Potassium Sorbate, Fragrance, Cetylpyridinium Chloride, Sodium Saccharin, Citric Acid, Methyl Diisopropyl Propionamide, Sucralose, CI 17200, CI 42090

🎯 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 ↗

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 Brush Buddies DISNEY PRINCESS ANTICAVITY FLUORIDE - Grand Grape (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
Disabling79
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 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.

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 — 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.
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 Ashtel Studios Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Ashtel Studios Inc. 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.
← 70108-0318-01 · Ashtel 70108-0320-01 · Ashtel →
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.