NDC codes

FDA NDC Directory
Product NDC (as listed)35000-971Labeler and product segments. Claims need a package NDC.
Product NDC at billing width35000-0971Add 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
35000-971-4635000097146130 g in 1 TUBE (35000-971-46)Marketed from Mar 12, 2015

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

Generic name (nonproprietary)
sodium fluoride
Active ingredients
Sodium fluoride — 1.1 mg/g
Dosage form
Paste, Dentifrice
Route
Dental
Labeler
Colgate-Palmolive CompanyNDC labeler code 35000
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 021
Marketing start
Marketing end
Identifiers
Product ID 35000-971_ff71a638-7218-48b4-9efe-4503c0683f1bSPL ID ff71a638-7218-48b4-9efe-4503c0683f1bSPL set ID 16634b99-f305-48bf-ac54-a9f53797a9e5RxCUI 416783UNII 8ZYQ1474W7UPC 0035000782946

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

N435000097146 followed by a unit qualifier and the quantity

Package 35000-0971-46. 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 helps protect against cavities

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 35000-971

What is NDC 35000-971?
35000-971 is the product NDC for Colgate Minions Mild Bubble Fruit Fluoride, Sodium fluoride 1.1 mg/g paste, dentifrice, listed with the FDA by Colgate-Palmolive Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Colgate Minions Mild Bubble Fruit Fluoride (Sodium fluoride).
What is the active ingredient?
Sodium fluoride.
Who is the labeler?
Colgate-Palmolive Company, NDC labeler code 35000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Colgate Minions Mild Bubble Fruit Fluoride?
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
Pro-Syssodium fluorideSodium fluoride .11 g/100gPaste, DentifriceDental, OralBenco Dental66975-720
Colgate Kids Mild Bubble Fruit Flavorsodium fluorideSodium fluoride 1.1 mg/gGel, DentifriceDentalColgate-Palmolive Company35000-918
ACT Restoring Anticavity Fluoride Cool Mintsodium fluorideSodium fluoride .2 mg/mLMouthwashTopicalChattem, Inc.41167-0957
Anticavity Fluoride Rinsesodium fluorideSodium fluoride .2 mg/mLMouthwashOralHARRIS TEETER72036-213
Freshmint Anticavity Fluoridesodium fluorideSodium fluoride 2.2 mg/gGel, DentifriceDentalNew World Imports, Inc51824-068
Ionite Hstannous fluorideStannous fluoride .63 mg/100mLMouthwashDentalDharma Research, Inc.53045-275
smart way MINT cavity protectionsodium monofluorophosphateSodium monofluorophosphate .13 g/100gPaste, DentifriceDentalThe Kroger Co.59450-010
Sodium Monofluorophosphatewhite toothpasteSodium monofluorophosphate 760 mg/gPasteDentalDynarex Corporation67777-181
Anticavity mouth rinse Low-foaming Spearmint718 us variant anticavity mouth rinse low-foaming spearmintSodium fluoride .02 g/100mLMouthwashOralDyson Technology Limited87649-7180
TheraBreath Anticavitysodium fluorideSodium fluoride .002 mg/10mLRinseOralChurch & Dwight Co., Inc.10237-265
Colgate Strawberry Burstsodium fluorideSodium fluoride 1.1 mg/gGel, DentifriceDentalColgate-Palmolive Company35000-915
ACT Anticavity Fluoride Kids Bubblegumsodium fluorideSodium fluoride .2 mg/mLRinseTopicalChattem, Inc.41167-0944
United Airlines Therabody UPP Kitsodium monofluorophosphate—KitWessco International42509-136
Ionite Hstannous fluorideStannous fluoride .63 mg/100mLMouthwashDentalDharma Research, Inc.53045-276
Morning Fresh Mint Toothpaste, with FluorideSodium monofluorophosphate 1.3 mg/mLPasteDentalDynarex Corporation67777-190
ULTRA BRITE Baking Soda and Peroxide Whitening Cool Mintsodium monofluorophosphateSodium monofluorophosphate 1 mg/gPaste, DentifriceDentalColgate-Palmolive Company35000-916
ACT Anticavity Fluoride Kids Groovy Grapesodium fluorideSodium fluoride .2 mg/mLRinseTopicalChattem, Inc.41167-0945
Eurofresh Whiteningsodium fluorideSodium fluoride 1.08 mg/gPaste, DentifriceTopicalFarmasi US LLC74690-008
Bubble Fresh Toothpaste, with FluorideSodium fluoride 220 mg/gPasteDentalDynarex Corporation67777-191
Pro-Syssodium fluoride and potassium nitrateSodium fluoride .11 g/100gPaste, DentifriceDental, OralBenco Dental66975-700

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