Home › NDC Lookup › Ingredients › Sodium Fluoride › 37000-0862-01
💊image loading
(from DailyMed)

Crest 3D White Luxe Diamond Strong Sodium Fluoride .1 mg/mL Rinse, 473 mL — NDC 37000-862-01 (Billing 37000-0862-01)

by The Procter & Gamble Manufacturing Company · 473 mL in 1 BOTTLE, PLASTIC

This is a package of 473 mL of Crest 3D White Luxe Diamond Strong Sodium Fluoride .1 mg/mL Rinse from The Procter & Gamble Manufacturing Company, marketed since Feb 2015 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 37000-0862-01
🏷️ FDA NDC (as labeled) 37000-862-01 billing pads the product segment with a zero
This package
Contains473 mL Pack sizes3 compare ↓
Main listing for product 37000-862 · Also comes in: 2 bottles 37000-862-03 946 ml 37000-862-02
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) 37000-862-01
Product NDC 37000-862
11-digit billing NDC 37000086201
RxCUI 1090579, 1486338
UNII 8ZYQ1474W7
Application # M021
SPL Set ID c1420129-5460-4900-ac9a-356d2d7c60a2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-02-19
Route ORAL
Dosage form RINSE
Substance SODIUM FLUORIDE

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

GPI-14 97552000000000
GPI class Pampers Baby Dry Size 3
Quick answers
  • GPI-14 (Medi-Span): 97552000000000
  • RxCUI (RxNorm): 1090579
Why two NDCs? The FDA registers this code as 37000-862-01 — 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 → 37000-0862-01. 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?

This is an over-the-counter oral rinse product in the fluoride monograph category. It contains sodium fluoride, a mineral compound that is typically used in oral care products to help strengthen tooth enamel and reduce the risk of tooth decay. The product is meant to be rinsed in the mouth rather than swallowed. Fluoride rinses are commonly used as a supplemental step in daily dental hygiene routines.

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.
Try another pack size: 2 bottles 946 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
37000-0862-01 You're viewing this Main listing 473 mL in 1 BOTTLE, PLASTIC 2015-02-19 — Active
37000-0862-02 37000-862-02 946 mL in 1 BOTTLE, PLASTIC 2015-02-19 — Active
37000-0862-03 37000-862-03 2 BOTTLE in 1 CELLO PACK / 946 mL in 1 BOTTLE 2015-02-19 — Active

Pack size FAQ

What quantity is in this package?
This package contains 473 mL — 473 ml in 1 bottle, plastic.
How does this package differ from NDC 37000-0862-02?
Both are Crest 3D White Luxe Diamond Strong Sodium Fluoride .1 mg/mL Rinse — the drug itself is identical. This page's package is the 473 mL one, while NDC 37000-0862-02 is the 946 ml package.
What NDC number is used to bill for this package of Crest 3D White Luxe Diamond Strong Sodium Fluoride .1 mg/mL Rinse?
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
Crest 3D White Luxe Diamond Strong .1 mg/mLthis 37000-0862-01 The 473 ml — — FDA listed —
Oral Antivavity .1 mg/mL 76162-0576-86 Topco 1000 ml — — FDA listed —
Alcohol Free Refreshing Mint .1 mg/mL 37808-0576-86 H 1000 ml — — FDA listed —
Crest Pro-Health Advanced Complete Care Anticavity Fluoride .1 mg/mL 69423-0751-01 The 1000 ml — — FDA listed —
Crest Deep Cleanse Cavity Defense .1 mg/mL 84126-0607-16 The 475 ml — — FDA listed —
Anticavity Fluoride Rinse .1 mg/mL 55319-0163-86 Family 1000 ml — — FDA listed —
Anticavity .1 mg/mL 59450-0971-86 The 1000 ml — — FDA listed —
Listerine Total Care Kids Anticavity Fluoride Rinse Bubble Blast .1 mg/mL 69968-0903-05 Kenvue 500 ml — — FDA listed —
Anticavity Fluoride Rinse .1 mg/mL 11673-0163-86 Target 1000 ml — — FDA listed —
Anticavity .1 mg/mL 37808-0435-45 H 946 ml — — FDA listed —
Anticavity .1 mg/mL 55301-0163-86 Your 1000 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 —
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 Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mint .1 mg/mL 69968-0924-01 Kenvue 1000 ml — — FDA listed —
Anticavity .1 mg/mL 72476-0005-86 ADUSA 1000 ml — — FDA listed —
Crest Pro-Health Advanced Multi-Protection .1 mg/mL 84126-0600-02 The 2 bottles — — FDA listed —
Anticavity .1 mg/mL 36800-0803-43 Topco 474 ml — — FDA listed —
Crest Pro-Health Advanced w/Extra Whitening .1 mg/mL 37000-0867-01 The 473 ml — — FDA listed —
Anticavity Fluoride Rinse .1 mg/mL 37808-0163-77 H 500 ml — — Discontinued —
Anticavity .1 mg/mL 49035-0163-86 Walmart 1000 ml — — FDA listed —
Anticavity .1 mg/mL 55910-0971-86 Old 1000 ml — — FDA listed —
Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble Blast .1 mg/mL 69968-0690-05 Kenvue 500 ml — — FDA listed —
Listerine Total Care Fresh Mint Anticavity Fluoride .1 mg/mL 69968-0787-01 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 Intense Anticavity Fluoride Mouthwash .1 mg/mL 69968-0952-01 Kenvue 1000 ml — — FDA listed —
Kids Crest Bubblegum Rush .1 mg/mL 37000-0167-05 The 500 ml — — FDA listed —
Glowing White .1 mg/mL 53942-0435-45 Demoulas 946 ml — — FDA listed —
Anticavity Fluoride Rinse .1 mg/mL 56062-0163-86 Publix 1000 ml — — FDA listed —
Listerine Clinical Solutions Enamel Strength Alpine Mint .1 mg/mL 69968-0881-01 Kenvue 1000 ml — — FDA listed —
Anticavity .1 mg/mL 49035-0971-86 Walmart 1000 ml — — FDA listed —
Anticavity .1 mg/mL 55910-0163-86 Old 1000 ml — — Discontinued —
Kids Crest Strawberry Rush .1 mg/mL 69423-0895-16 The 500 ml — — FDA listed —
Oral Antivavity .1 mg/mL 72036-0576-86 HARRIS 1000 ml — — FDA listed —
Oral Antivavity .1 mg/mL 72288-0576-86 Amazon.com 1000 ml — — FDA listed —
Anticavity .1 mg/mL 72476-0435-43 ADUSA 473 ml — — FDA listed —
Anticavity .1 mg/mL 36800-0971-86 Topco 1000 ml — — FDA listed —
Anticavity .1 mg/mL 41163-0971-86 United 1000 ml — — FDA listed —
Anticavity .1 mg/mL 53942-0971-86 Demoulas 1000 ml — — FDA listed —
Anticavity .1 mg/mL 56062-0971-86 Publix 1000 ml — — FDA listed —
Crest Pro-Health Multi-Protection plus Extra Whitening .1 mg/mL 84126-0651-01 The 946 ml — — FDA listed —
Anticavity .1 mg/mL 37808-0119-86 H 1000 ml — — FDA listed —
Anticavity .1 mg/mL 41163-0043-86 United 1000 ml — — FDA listed —
Oral Antivavity .1 mg/mL 41250-0576-86 Meijer, 1000 ml — — FDA listed —
Anticavity .1 mg/mL 55301-0435-43 Your 473 ml — — FDA listed —
Crest 3D White Brilliance Pro Rinse .1 mg/mL 69423-0838-32 The 946 ml — — FDA listed —
Listerine Total Care Fresh Mint Anticavity .1 mg/mL 69968-0178-01 Kenvue 250 ml — — Discontinued —
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 —
Anticavity Fluoride Rinse .1 mg/mL 71141-0159-32 Lidl 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 —
Listerine Clinical Solutions Teeth Strength Alpine Mint .1 mg/mL 69968-0819-01 Kenvue 1000 ml — — FDA listed —
Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash .1 mg/mL 69968-0904-03 Kenvue 27 ml — — FDA listed —
Crest Pro-Health Mouthwash Multi-Protection Strong Mint .1 mg/mL 84126-0647-01 The 1000 ml — — FDA listed —
Crest 3D White Strength Whitening Enamel Protection .1 mg/mL 84126-0652-16 The 946 ml — — FDA listed —
Anticavity .1 mg/mL 41163-0011-45 United 946 ml — — FDA listed —
Anticavity .1 mg/mL 41250-0971-86 Meijer, 1000 ml — — FDA listed —
Anticavity .1 mg/mL 56062-0435-43 Publix 474 ml — — Discontinued —
Anticavity .1 mg/mL 00363-0171-86 Walgreen 1000 ml — — Discontinued —
Anticavity .1 mg/mL 69842-0548-86 CVS 1000 ml — — FDA listed —
Listerine Total Care Zero Alcohol Anticavity Fresh Mint .1 mg/mL 69968-0194-01 Kenvue 1000 ml — — FDA listed —
Listerine Smart Rinse Anticavity Fluoride Rinse - Pink Lemonade Flavor .1 mg/mL 69968-0691-05 Kenvue 500 ml — — Discontinued —
Listerine Whitening Extra Mild Alcohol Free Anticavity Fluoride Mouthwash .1 mg/mL 69968-1008-01 Kenvue 1000 ml — — FDA listed —
sodium fluoride .1 mg/mL 71141-0576-86 Lidl 1000 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

🏛️
2015
On the market since
Feb 2015
📍
2026
Currently FDA-listed
11 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
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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 BBX060AN9V
    Hydrogen peroxide is a chemical solution used in medicines as a cleansing agent or preservative. It helps prevent bacterial growth and is sometimes used in oral or topical formulations.
  • UNII E4GA8884NN
    Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
  • UNII TUF2IVW3M2
    Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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 22ADO53M6F
    A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

The official label also stateswater, glycerin, propylene glycol, hydrogen peroxide, poloxamer 407, flavor, sodium saccharin, phosphoric acid, sucralose, disodium phosphate

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

LabelerThe Procter & Gamble Manufacturing Company
FDA applicationM021 (OTC MONOGRAPH DRUG)
Labeler code37000
First marketedFeb 2015
Product typeHuman Otc Drug
Portfolio850 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 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 8 words ▾

Use Aids in the prevention of dental cavities

⏱️ Dosage and Administration 87 words ▾

Directions Adults and children 12 years & older: Use twice a day after brushing your teeth with a 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 12 years of age: Consult a dentist or doctor.

⚠️ Warnings 27 words ▾

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

🧪 Active Ingredient 9 words ▾

Active ingredient Sodium Fluoride 0.0219% (0.01% w/v fluoride ion)

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients water, glycerin, propylene glycol, hydrogen peroxide, poloxamer 407, flavor, sodium saccharin, phosphoric acid, sucralose, disodium phosphate

🎯 Purpose 2 words ▾

Purpose Anticavity

📄 Keep Out of Reach of Children 26 words ▾

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

📄 Questions or Comments 2 words ▾

Questions? 1-800-285-9139

📄 Package Label / Principal Display Panel 48 words ▾

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label WITH FLUORIDE ALCOHOL FREE Crest ® 3D WHITE ANTICAVITY FLUORIDE MOUTHWASH DIAMOND STRONG FROM THE MAKERS OF WHITESTRIPS ® STRENGTHENS ENAMEL WHITENS TEETH HELPS PREVENT CAVITIES 91518226 WINTERMINT IMPORTANT: Read directions for proper use. 946 mL (32 FL OZ) Label

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
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) ✓ 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 The Procter & Gamble Manufacturing Company. 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 2 other package presentations of this same product, including 2 bottles (37000-0862-03), 946 ml (37000-0862-02). 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?
The Procter & Gamble Manufacturing Company 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.
← 37000-0843-16 · The 37000-0863-04 · The →
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.