Over-the-counter drug · OTC MONOGRAPH DRUG

Anticavity Fluoride Rinse (Sodium fluoride) NDC 36800-004

Sodium fluoride .2 mg/mL · Rinse · Oral · Topco Associates LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-004Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0004Add 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
36800-004-4436800000444532 mL in 1 BOTTLE, PLASTIC (36800-004-44)Marketed from Apr 8, 2004

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Anticavity Fluoride Rinse
Generic name (nonproprietary)
sodium fluoride
Active ingredients
Sodium fluoride — .2 mg/mL
Dosage form
Rinse
Route
Oral
Labeler
Topco Associates LLCNDC labeler code 36800
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 021
Marketing start
Listing expires
Identifiers
Product ID 36800-004_4ab75798-a4e5-d8f0-e063-6294a90ad09aSPL ID 4ab75798-a4e5-d8f0-e063-6294a90ad09aSPL set ID 3b04142a-4a65-45ba-a5a2-e62b0c47ec55RxCUI 240698UNII 8ZYQ1474W7UPC 0036800334175

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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N436800000444 followed by a unit qualifier and the quantity

Package 36800-0004-44. 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)

Use aids in the prevention of dental cavities

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 36800-004

What is NDC 36800-004?
36800-004 is the product NDC for Anticavity Fluoride Rinse (sodium fluoride), Sodium fluoride .2 mg/mL rinse, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Anticavity Fluoride Rinse (Sodium fluoride).
What is the active ingredient?
Sodium fluoride.
Who is the labeler?
Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Anticavity Fluoride Rinse?
20 other product NDCs are listed under this name. See all Anticavity Fluoride Rinse 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 Anticavity Fluoride Rinse NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Anticavity fluoride rinsesodium fluorideSodium fluoride .2 mg/mLMouthwashOralMeijer, Inc.79481-083879481-0838-01
Anticavity fluoride rinsesodium fluorideSodium fluoride .2 mg/mLMouthwashOralTopco Associates LLC76162-83876162-0838-38
Anticavity Fluoride Rinsesodium fluorideSodium fluoride .2 mg/mLMouthwashOralNice-Pak Products, LLC11344-00411344-0004-44
Anticavity Fluoride Rinsesodium fluorideSodium fluoride .2 mg/mLMouthwashOralDemoulas Super Markets, Inc53942-21353942-0213-44
Anticavity Fluoride Rinsesodium fluorideSodium fluoride .2 mg/mLMouthwashOralValu Merchandisers Company63941-17063941-0170-44
Anticavity Fluoride Rinsesodium fluorideSodium fluoride .2 mg/mLMouthwashOralAmazon.com Services LLC72288-21372288-0213-44
Anticavity Fluoride Rinsesodium fluorideSodium fluoride .1 mg/mLMouthwashOralLidl US, LLC71141-15971141-0159-32
Anticavity Fluoride Rinsesodium fluorideSodium fluoride .2 mg/mLMouthwashOralH E B37808-21337808-0213-44
Anticavity Fluoride Rinsesodium fluorideSodium fluoride .1 mg/mLMouthwashOralFamily Dollar Stores, Inc55319-16355319-0163-86
Anticavity Fluoride Rinsesodium fluorideSodium fluoride .1 mg/mLMouthwashOralPublix Super Markets, Inc.56062-16356062-0163-86

All 21 Anticavity Fluoride Rinse NDCs

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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