Over-the-counter drug · OTC MONOGRAPH DRUG

Mouth Rinse (Sodium fluoride) NDC 36800-001

Sodium fluoride .1 mg/mL · Mouthwash · Oral · Topco Associates LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0001Add 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
36800-001-86368000001861000 mL in 1 BOTTLE, PLASTIC (36800-001-86)Marketed from Dec 30, 2010

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)
Mouth Rinse
Generic name (nonproprietary)
sodium fluoride
Active ingredients
Sodium fluoride — .1 mg/mL
Dosage form
Mouthwash
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 36800-001_4ab7fbe5-4281-9c7d-e063-6394a90a2392SPL ID 4ab7fbe5-4281-9c7d-e063-6394a90a2392SPL set ID c640adc0-e178-4b6a-af44-07d2f7da81d3RxCUI 1038904UNII 8ZYQ1474W7

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

N436800000186 followed by a unit qualifier and the quantity

Package 36800-0001-86. 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 36800-001

What is NDC 36800-001?
36800-001 is the product NDC for Mouth Rinse (sodium fluoride), Sodium fluoride .1 mg/mL mouthwash, 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?
Mouth 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 Mouth Rinse?
5 other product NDCs are listed under this name. See all Mouth 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 Mouth Rinse NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Mouth Rinseeucalyptol, menthol, methyl salicylate, thymolEucalyptol .92 mg/mL + 3 more ingredientsMouthwashOralThe Kroger Co.59450-90159450-0901-86
Mouth Rinsesodium fluorideSodium fluoride .1 mg/mLMouthwashOralWalgreen Co.0363-016300363-0163-86
Mouth Rinseeucalyptol, menthol, methyl salicylate, thymolEucalyptol .92 mg/mL + 3 more ingredientsMouthwashOralUnited Natural Foods, Inc. dba UNFI41163-31841163-0318-1241163-0318-7741163-0318-86
Mouth Rinseeucalyptol, menthol, methyl salicylate, thymolEucalyptol .92 mg/mL + 3 more ingredientsMouthwashOralOld East Main Co.55910-31855910-0318-12
Mouth Rinseeucalyptol, menthol, methylsalicylate, thymolEucalyptol .92 mg/mL + 3 more ingredientsMouthwashOralThe Kroger Co.30142-07230142-0072-1230142-0072-7730142-0072-86

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
Auraglow Whiteningsodium fluorideSodium fluoride 2.3 mg/gPaste, DentifriceDentalAuraglow LLC81740-003
Crayola ANTICAVITY STRAWBERRY FLAVORsodium fluorideSodium fluoride .243 g/100gPaste, DentifriceDentalAshtel Studios, Inc.70108-080
Made by Dentists For Kids Eyeball Juice (Watermelon)sodium fluorideSodium fluoride 1.5 mg/gPasteDentalMADE BY DENTISTS INC75065-030
White Glo Advantage Anticavity Professional Whiteningsodium monofluorophosphateSodium monofluorophosphate 7.6 mg/gPasteTopicalWHITE GLO USA INC73656-027
AutoBrush Mintsodium fluorideSodium fluoride .243 g/100mLLiquidOralLander Enterprises, LLC82913-011
Hello Unicorn Splashsodium fluorideSodium fluoride .02 g/100mLMouthwashDentalAccupac LLC44038-0687
Crest 3D White Stain Eraser Icy Clean Mintsodium fluorideSodium fluoride 1.5 mg/gPaste, DentifriceOralThe Procter & Gamble Manufacturing Company69423-773
White Glo Professional Choice Twin Packsodium fluoride—KitWHITE GLO USA INC73656-024
Therabreath Healthy Gumsstannous fluorideStannous fluoride .454 g/100gPaste, DentifriceOralChurch & Dwight Co., Inc.10237-271
Crest 3D White Vibrant Mintsodium fluorideSodium fluoride 1.5 mg/gPaste, DentifriceOralThe Procter & Gamble Manufacturing Company69423-774
Complete Protectionstannous fluorideStannous fluoride .15 g/100gPaste, DentifriceDental, OralTarget11673-366
Anticavitysodium fluorideSodium fluoride .1 mg/mLRinseOralH E B37808-119
Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mintsodium fluorideSodium fluoride .1 mg/mLMouthwashOralKenvue Brands LLC69968-0924
White Glo Advantage Anticavity Fluoride Purplesodium monofluorophosphateSodium monofluorophosphate 7.6 mg/gPasteTopicalWHITE GLO USA INC73656-026
Hismilesodium fluorideSodium fluoride .243 g/100gGelDentalHISMILE PTY LTD83013-321
Delta Comfort Plus Amenitysodium monofluorophosphate—KitBuzz Products Inc.69491-043
Hismilebanana flavor sodium fluoride anticavity toothpasteSodium fluoride 2.4 mg/gGelDentalHismile Pty Ltd83013-319
TP OW Stainfighter Clean Mintsodium fluorideSodium fluoride 1.1 mg/gPaste, DentifriceDentalColgate-Palmolive Company35000-999
Sodium FluorideSodium fluoride 2.43 mg/gPaste, DentifriceDentalSafco Dental Supply LLC67239-0226
Delta Travel Kit Comfort plussodium monofluorophosphate—KitBuzz Products Inc.69491-039

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