NDC codes

FDA NDC Directory
Product NDC (as listed)57511-0202Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57511-0202Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
57511-0202-157511020201225 mL in 1 BOTTLE, PUMP (57511-0202-1)Marketed from Aug 25, 2016

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Stance
Generic name (nonproprietary)
0.63% stannous fluoride concentrate rinse
Active ingredients
Stannous fluoride — 1.2 mg/mL
Dosage form
Rinse
Route
Topical
Labeler
Elevate Oral CareNDC labeler code 57511
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 021
Marketing start
Listing expires
Identifiers
Product ID 57511-0202_4cc11009-2f4b-565a-e063-6394a90ab093SPL ID 4cc11009-2f4b-565a-e063-6394a90ab093SPL set ID 3ae8badf-f960-62fd-e054-00144ff8d46cRxCUI 583459UNII 3FTR44B32Q

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N457511020201 followed by a unit qualifier and the quantity

Package 57511-0202-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Uses Indications Uses

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57511-0202

What is NDC 57511-0202?
57511-0202 is the product NDC for Stance, Stannous fluoride 1.2 mg/mL rinse, listed with the FDA by Elevate Oral Care. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Stance (0.63% Stannous Fluoride Concentrate Rinse).
What is the active ingredient?
Stannous fluoride.
Who is the labeler?
Elevate Oral Care, NDC labeler code 57511. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Stance?
1 other product NDC are listed under this name. See all Stance NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Stance NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Stance0.63% stannous fluoride concentrate rinseStannous fluoride 1.2 mg/mLRinseTopicalElevate Oral Care57511-020157511-0201-01

Other NDCs under M 021

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 021
ProductStrengthForm · routeLabelerProduct NDC
365 Everyday Value Cavity Fighting and Whiteningsodium monoflourophosphateSodium monofluorophosphate .13 g/100gPaste, DentifriceDentalWhole Foods Market, Inc.42681-5002
365 Everyday Value Kids Flouridesodium monofluorophosphateSodium monofluorophosphate .13 g/100gPaste, DentifriceDentalWhole Foods Market, Inc.42681-5276
3ECARE Dual FormulaToothpastefor sensitiveteethpotassium nitrate sodium monofluorophosphatePotassium nitrate 5 g/100g; Sodium monofluorophosphate 5 g/100gPaste, DentifriceDentalHangzhou Namei Zhikang Technology Co., Ltd.87514-004
3ECARE Dual FormulaWhiteningToothpastesodium fluorideSodium fluoride .155 g/100gPaste, DentifriceDentalHangzhou Namei Zhikang Technology Co., Ltd.87514-003
A and H Plus Therabreath Breath Freshnerssodium fluorideSodium fluoride .243 g/100gPaste, DentifriceOralChurch & Dwight Co., Inc.10237-676
ACT Anticavity Fluoride Arctic Blastsodium fluorideSodium fluoride .2 mg/mLMouthwashTopicalChattem, Inc.41167-0937
ACT Anticavity Fluoride Cinnamonsodium fluorideSodium fluoride .2 mg/mLRinseTopicalChattem, Inc.41167-0940
ACT Anticavity Fluoride Kids Bubblegumsodium fluorideSodium fluoride .2 mg/mLRinseTopicalChattem, Inc.41167-0944
ACT Anticavity Fluoride Kids Groovy Grapesodium fluorideSodium fluoride .2 mg/mLRinseTopicalChattem, Inc.41167-0945
ACT Anticavity Fluoride Kids Wild Watermelonsodium fluoride 0.24 (0.14 w/v fluoride ion)Sodium fluoride 1.4 mg/gPasteTopicalChattem, Inc.41167-0924
ACT Anticavity Fluoride Mintsodium fluorideSodium fluoride .2 mg/mLRinseTopicalChattem, Inc.41167-0942
ACT Kids Anticavity Fluoride Bubble Gum Blowoutsodium fluorideSodium fluoride 1.4 mg/gPasteTopicalChattem, Inc.41167-0922
ACT Kids Anticavity Fluoride Groovy Grapesodium fluorideSodium fluoride 1.4 mg/gPaste, DentifriceTopicalChattem, Inc.41167-0926
ACT Kids Anticavity Fluoride Pineapple Punchsodium fluorideSodium fluoride .2 mg/mLMouthwashTopicalChattem, Inc.41167-0953
ACT Kids Anticavity Fluoride Wild Watermelonsodium fluorideSodium fluoride .5 mg/mLRinseTopicalChattem, Inc.41167-0938
ACT Kids Berry Blastsodium fluorideSodium fluoride .5 mg/mLRinseOralChattem, Inc.41167-0976
ACT Kids Pure Protect Anticavity- Simply Strawberrysodium fluorideSodium fluoride .5 mg/mLRinseOralChattem, Inc.41167-0915
ACT Restoring Anticavity Fluoride Cool Mintsodium fluorideSodium fluoride .2 mg/mLMouthwashTopicalChattem, Inc.41167-0957
ACT Restoring Anticavity Fluoride Cool Mintsodium fluorideSodium fluoride .09 mg/mLMouthwashTopicalChattem, Inc.41167-0981
ACT Restoring Anticavity Fluoride Mint Burstsodium fluorideSodium fluoride .2 mg/mLMouthwashOralChattem, Inc.41167-0978

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