Home › NDC Lookup › Ingredients › Potassium Nitrate And Sodium Fluoride › 00135-0529-05
Sensodyne Fresh Mint potassium nitrate and sodium fluoride 50 mg/g; 1.15 mg/g Paste — NDC 00135-0529-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sensodyne Fresh Mint potassium nitrate and sodium fluoride 50 mg/g; 1.15 mg/g Paste — NDC 0135-0529-05 (Billing 00135-0529-05)

by Haleon US Holdings LLC · 1 TUBE in 1 CARTON / 77 g in 1 TUBE

This is a package of Sensodyne Fresh Mint potassium nitrate and sodium fluoride 50 mg/g; 1.15 mg/g Paste from Haleon US Holdings LLC, marketed since Sep 1990 and currently FDA-listed.

NDC 00135-0529-05
🏷️ FDA NDC (as labeled) 0135-0529-05 billing pads the labeler segment with a zero
This package
Contains77 g in 1 tube Pack sizes5 compare ↓
Product page 00135-0529-01 Also comes in: 23 g 0135-0529-01 113 g 0135-0529-04 2 tubes 0135-0529-03 23 g 0135-0529-10
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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 0135-0529-05 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0135 labeler · 0529 product · 05 package
Package marketed since
Sep 30, 1990
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0135052905 1
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0135-0529-05
Product NDC 0135-0529
11-digit billing NDC 00135052905
RxCUI 1038841, 1038929, 1086243
UNII RU45X2JN0Z, 8ZYQ1474W7
Application # M022
SPL Set ID 1ed4a62b-f1d3-4740-8150-b94e02398740
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1990-09-30
Route DENTAL
Dosage form PASTE
Substance POTASSIUM NITRATE; SODIUM FLUORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 97503000004400
GPI class Sensodyne Max St/Fluoride
Quick answers
  • GPI-14 (Medi-Span): 97503000004400
  • RxCUI (RxNorm): 1038841
Why two NDCs? The FDA registers this code as 0135-0529-05 — a 4-4-2 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 labeler segment → 00135-0529-05. 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.

Clinical

🧪 What is this product?

This is an over-the-counter toothpaste sold under FDA's monograph rules for dental products. It contains potassium nitrate, which is commonly used to reduce tooth sensitivity by blocking sensation from reaching the nerve, and sodium fluoride, which is typically used to strengthen tooth enamel and help prevent cavities. The product is applied topically to teeth during normal brushing.

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.
Try another pack size: 23 g 113 g 2 tubes 23 g
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
00135-0529-01 0135-0529-01 Main listing 1 TUBE in 1 CARTON / 23 g in 1 TUBE 2019-01-14 — Active
00135-0529-03 0135-0529-03 2 TUBE in 1 CARTON / 113 g in 1 TUBE 2014-12-16 — Active
00135-0529-04 0135-0529-04 1 TUBE in 1 CARTON / 113 g in 1 TUBE 1990-09-30 — Active
00135-0529-05 You're viewing this 1 TUBE in 1 CARTON / 77 g in 1 TUBE 1990-09-30 — Active
00135-0529-10 0135-0529-10 23 g in 1 TUBE 2023-01-02 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 77 g in 1 tube.
What NDC number is used to bill for this package of Sensodyne Fresh Mint potassium nitrate and sodium fluoride 50 mg/g; 1.15 mg/g Paste?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
SENSODYNE PRONAMEL mineral BOOST refreshing peppermint 50 mg/g; 1.15 mg/g 00135-0450-01 Haleon 1 tube — — Discontinued —
SENSODYNE PRONAMEL Daily Protection 50 mg/g; 1.15 mg/g 00135-0460-01 Haleon 1 tube — — FDA listed —
SENSODYNE Advanced Whitening 50 mg/g; 1.15 mg/g 00135-0479-01 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL mineral BOOST whitening action 50 mg/g; 1.15 mg/g 00135-0480-01 Haleon 1 tube — — Discontinued —
SENSODYNE PRONAMEL Intensive Enamel Repair Whitening 50 mg/g; 1.15 mg/g 00135-0481-01 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL Gentle Whitening 50 mg/g; 1.15 mg/g 00135-0484-01 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh 50 mg/g; 1.15 mg/g 00135-0486-01 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint 50 mg/g; 1.15 mg/g 00135-0492-01 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL Fresh Breath 50 mg/g; 1.15 mg/g 00135-0520-01 Haleon 1 tube — — FDA listed —
Sensodyne Fresh Mint 50 mg/g; 1.15 mg/gthis 00135-0529-05 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL Multi Action 50 mg/g; 1.15 mg/g 00135-0568-04 Haleon 1 tube — — FDA listed —
Sensodyne Pronamel Gentle Whitening Advanced 50 mg/g; 1.15 mg/g 00135-0580-01 Haleon 1 tube — — FDA listed —
sensodyne 50 mg/g; 1.15 mg/g 00135-0593-01 Haleon 1 tube — — FDA listed —
Sensodyne Pronamel Strong and Bright Enamel Mint 50 mg/g; 1.15 mg/g 00135-0602-01 Haleon 1 tube — — FDA listed —
Sensodyne Pronamel Strong and Bright Enamel Extra Fresh 50 mg/g; 1.15 mg/g 00135-0603-01 Haleon 1 tube — — FDA listed —
Sensodyne Pronamel Gentle Whitening Fresh Mint 50 mg/g; 1.15 mg/g 00135-0644-01 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL Active Shield Fresh Mint 50 mg/g; 1.15 mg/g 00135-0700-01 Haleon 1 tube — — FDA listed —
SENSODYNE PRONAMEL Active Shield Cool Mint 50 mg/g; 1.15 mg/g 00135-0701-01 Haleon 1 tube — — FDA listed —
Sensodyne Clinical White Stain Protector 50 mg/g; 2.5 mg/g 00135-0702-01 Haleon 1 tube — — FDA listed —
Sensodyne Clinical White Enamel Strengthening 50 mg/g; 2.5 mg/g 00135-0703-01 Haleon 1 tube — — FDA listed —
Sensodyne Pronamel Clinical Enamel Strength Deep Clean 50 mg/g; 1.15 mg/g 00135-0810-01 Haleon 23 g — — FDA listed —
Sensodyne Pronamel Clinical Enamel Strength Whitening Action 50 mg/g; 1.15 mg/g 00135-0811-02 Haleon 1 tube — — FDA listed —
NATEAN Clean plus Sensitivity Relief 50 mg/g; 1.5 mg/g 00135-1250-01 Haleon 1 tube — — FDA listed —
Sensodyne Cavity and Sensitivity 50 mg/g; 1.5 mg/g 00135-4032-01 Haleon 1 tube — — FDA listed —
Sensodyne Nourish Gently Soothing 50 mg/g; 1.15 mg/g 00135-5026-01 Haleon 1 tube — — FDA listed —
Sensodyne Nourish Healthy White 50 mg/g; 1.15 mg/g 00135-5027-01 Haleon 1 tube — — FDA listed —
Sensodyne Natural white 50 mg/g; 1.15 mg/g 00135-5028-01 Haleon 1 tube — — FDA listed —
SENSODYNE Advanced Whitening Plus 50 mg/g; 1.11 mg/g 00135-5029-01 Haleon 4 tubes — — FDA listed —
Sensodyne Pronamel Gentle Whitening Advanced Plus 50 mg/g; 1.11 mg/g 00135-5030-01 Haleon 4 tubes — — FDA listed —
Sensodyne Clinical White Intensive Clean 50 mg/g; 1.1 mg/g 00135-5468-01 Haleon 1 tube — — FDA listed —
Sensodyne Pronamel Clinical Enamel Strength Fresh Breath 50 mg/g; 1.5 mg/g 00135-7753-01 Haleon 1 tube — — FDA listed —
Walgreens Sensitive Enamel Repair .15 g/100g; 5 g/100g 00363-0593-10 Walgreens 1 tube — — FDA listed —
Pronamel Repair Whitening .15 g/100g; 5 g/100g 11822-6310-01 Rite 1 tube — — FDA listed —
Intensive Enamel Repair Whitening TP 5 g/100g; .15 g/100g 36800-0362-10 Topco 1 tube — — FDA listed —
Opalescence Sensitivity Relief Whitening 50 mg/g; 1.1 mg/g 51206-0308-01 Ultradent 1 tube — — FDA listed —
Opal by Opalescence Sensitivity 50 mg/g; 1.1 mg/g 51206-0311-01 Ultradent 1 tube — — FDA listed —
CVS Health Sensitive Enamel Repair .15 g/100g; 5 g/100g 51316-0169-10 CVS 1 tube — — FDA listed —
CVS Health Clinical White Stain Protector .15 g/100g; 5 g/100g 51316-0205-10 CVS 1 tube — — FDA listed —
Pronamel Repair Whitening 5 g/100g; .15 g/100g 56062-0514-44 Publix 1 tube — — FDA listed —
Sensodyne Extra Whitening Cool Mint 50 mg/g; 1.15 mg/g 00135-0643-01 Haleon 1 tube — — FDA listed —
Sensodyne True white 50 mg/g; 1.15 mg/g 00135-0579-01 Haleon 1 tube — — FDA listed —
Sensodyne True white 50 mg/g; 1.15 mg/g 00135-0581-01 Haleon 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

🏛️
1990
On the market since
Sep 1990
📍
2026
Currently FDA-listed
36 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.

What it looks like

Color white / green
FlavorMint
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.

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

LabelerHaleon US Holdings LLC
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code00135
First marketedSep 1990
Product typeHuman Otc Drug
Portfolio405 products on file

More NDCs from Haleon US Holdings LLC labeler code 00135

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 24 words ▾

Uses builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities.

⏱️ Dosage and Administration 81 words ▾

Directions adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. children under 12 years of age: Consult a dentist or doctor.

⚠️ Warnings 62 words ▾

Warnings Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use. Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 8 words ▾

Other information do not store above 30°C (86°F)

🧪 Active Ingredient 28 words ▾

Active ingredients Potassium nitrate (5%) Sensodyne Fresh Mint and Fresh Impact: Sodium fluoride 0.25% (0.15% w/v fluoride ion) Sensodyne Extra Whitening: Sodium fluoride 0.24% (0.15% w/v fluoride ion)

🧪 Inactive Ingredients 76 words ▾

Inactive ingredients (Extra Whitening) water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, cocamidopropyl betaine, sodium methyl cocoyl taurate, xanthan gum, sodium hydroxide, sodium saccharin, sucralose

Inactive ingredients (Fresh Mint) water, sorbitol, hydrated silica, glycerin, flavor, cocamidopropyl betaine, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1

Inactive ingredients (Fresh Impact) water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, blue 1

🎯 Purpose 3 words ▾

Purposes Antihypersensitivity Anticavity

📄 Ask a Doctor Before Use If 35 words ▾

Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use.

📄 Keep Out of Reach of Children 26 words ▾

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-866-844-2797

📄 Package Label / Principal Display Panel ~2 min read ▾

Principal Display Panel #1 DENTIST RECOMMENDED BRAND HALEON SENSODYNE Extra Whitening with triple action cleaning formula TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION 24/7 SENSITIVITY PROTECTION* + Strong & Healthy Teeth What are sensitive teeth? Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or drinks) or gums recede, the dentin underneath becomes exposed.

This can lead to tooth sensitivity, for example, with cold and hot food and drinks. What does Sensodyne do? Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste - strong teeth and freshness. *with twice daily brushing.

24/7 SENSITIVITY PROTECTION* + Strong & Healthy Teeth Use Sensodyne Extra Whitening twice daily: • Long lasting sensitivity protection• every day • Contains fluoride to protect against cavities NET WT

4.0 OZ (113g) 62000000208004 Front Carton Sensodyne Extra Whitening 4 oz carton

Principal Display Panel #1 Dentist Recommended Brand HALEON SENSODYNE Fresh Mint with triple action cleaning formula TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION 24/7 SENSITIVITY PROTECTION* + Strong & Healthy Teeth NET WT

4.0OZ (113 g) What are sensitive teeth? Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or drinks) or gums recede, the dentin underneath becomes exposed.

This can lead to tooth sensitivity, for example, with cold and hot food and drinks. What does Sensodyne do? Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste - strong teeth and freshness. *with twice daily brushing.

24/7 SENSITIVITY PROTECTION* + Strong & Healthy Teeth Use Sensodyne Fresh Mint twice daily: • Long lasting sensitivity protection• every day • Contains fluoride to protect against cavities 62000000208036 Front Carton Sensodyne Fresh Mint 4 oz carton

Principal Display Panel NDC 0135-0528-04 #1 Dentist Recommended Brand SENSODYNE Fresh Impact TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION 24/7 SENSITIVITY PROTECTION* + Strong & Healthy Teeth NET WT

4.0OZ (113g) What are sensitive teeth? Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or drinks) or gums recede, the dentin underneath becomes exposed.

This can lead to tooth sensitivity, for example, with cold and hot food and drinks. What does Sensodyne do? Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste - strong teeth and freshness. *with twice daily brushing 24/7 SENSITIVITY PROTECTION* +Strong & Healthy Teeth Use Sensodyne Fresh Impact twice daily: • Long lasting sensitivity protection• every day • Contains fluoride to protect against cavities 6191 Front Carton Sensodyne Regular Fresh Impact 4 oz carton

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 Potassium nitrate and sodium fluoride — the ingredient across all brands.

Top reported reactions

Oral Discomfort79
Hyperaesthesia Teeth49
Oral Pain39
Toothache39
Product Complaint36
Oral Mucosal Exfoliation30
Condition Aggravated28

Age at onset

Adolescent1
Adult6
Elderly3

Reporter sex

576 reports
Male · 32%
Female · 68%

Serious outcomes

Hospitalization13
Disabling6
Death3
Life-threatening2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 263 1
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 ✓ Available
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 Haleon US Holdings LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 1 tube (00135-0529-01), 1 tube (00135-0529-04), 2 tubes (00135-0529-03). 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?
Haleon US Holdings LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00135-0525-03 · Haleon 00135-0532-02 · Haleon →
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.