Over-the-counter drug · OTC MONOGRAPH DRUG

Gel 1100 Grape (Sodium fluoride) NDC 61578-217

Sodium fluoride 1100 ug/g · Gel, Dentifrice · Dental · Dental Alliance Holdings LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)61578-217Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61578-0217Add 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
61578-217-016157802170168 g in 1 TUBE, WITH APPLICATOR (61578-217-01)Marketed from May 10, 2022

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)
Gel 1100 GrapeSuffix: Grape
Generic name (nonproprietary)
sodium fluoride
Active ingredients
Sodium fluoride — 1100 ug/g
Dosage form
Gel, Dentifrice
Route
Dental
Labeler
Dental Alliance Holdings LLCNDC labeler code 61578
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 021
Marketing start
Listing expires
Identifiers
Product ID 61578-217_8c79367f-d60d-484b-8e32-87de7cf75358SPL ID 8c79367f-d60d-484b-8e32-87de7cf75358SPL set ID f125fb04-5045-5367-e053-2a95a90aa73bRxCUI 416783UNII 8ZYQ1474W7UPC 0856596006007, 0856596006021, 0856596006014

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N461578021701 followed by a unit qualifier and the quantity

Package 61578-0217-01. 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)

Use Aids in the prevention of dental caries (cavities).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61578-217

What is NDC 61578-217?
61578-217 is the product NDC for Gel 1100 Grape (sodium fluoride), Sodium fluoride 1100 ug/g gel, dentifrice, listed with the FDA by Dental Alliance Holdings LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Gel 1100 Grape (Sodium fluoride).
What is the active ingredient?
Sodium fluoride.
Who is the labeler?
Dental Alliance Holdings LLC, NDC labeler code 61578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gel 1100 Grape?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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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