NDC codes

FDA NDC Directory
Product NDC (as listed)0135-0234Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00135-0234Add 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
0135-0234-0600135023406001350234061 TUBE in 1 CARTON (0135-0234-06) / 158.7 g in 1 TUBEMarketed from Mar 25, 2011
0135-0234-0800135023408001350234082 TUBE in 1 CARTON (0135-0234-08) / 158.7 g in 1 TUBEMarketed from Mar 25, 2011
0135-0234-0900135023409001350234093 TUBE in 1 CARTON (0135-0234-09) / 158.8 g in 1 TUBEMarketed from Feb 28, 2021

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Aquafresh Extreme Clean Whitening ActionSuffix: EXTREME CLEAN WHITENING ACTION
Generic name (nonproprietary)
sodium fluoride
Active ingredients
Sodium fluoride — 1.13 mg/g
Dosage form
Paste
Route
Dental
Labeler
Haleon US Holdings LLCNDC labeler code 0135
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 022
Marketing start
Listing expires
Identifiers
Product ID 0135-0234_4af3766f-39a7-abd8-e063-6294a90ad4a7SPL ID 4af3766f-39a7-abd8-e063-6294a90ad4a7SPL set ID aaff19d9-4ba5-462a-893b-7220feb25d6cRxCUI 1044547UNII 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 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

N400135023406 followed by a unit qualifier and the quantity

Package 00135-0234-06. 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 0135-0234

What is NDC 0135-0234?
0135-0234 is the product NDC for Aquafresh Extreme Clean Whitening Action, Sodium fluoride 1.13 mg/g paste, listed with the FDA by Haleon US Holdings LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Aquafresh Extreme Clean Whitening Action (Sodium fluoride).
What is the active ingredient?
Sodium fluoride.
Who is the labeler?
Haleon US Holdings LLC, NDC labeler code 0135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Aquafresh Extreme Clean Whitening Action?
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 022

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

FDA NDC Directory listings under M 022
ProductStrengthForm · routeLabelerProduct NDC
Hydrogen Peroxide 3 Percent ReadyInCasehydrogen peroxideHydrogen peroxide 3 mL/100mLLiquidTopicalP & L Development, LLC49580-0268
SalinenasalSodium chloride 6.5 mg/mLSprayNasalBi-Mart37835-998
CVS Health Sensitive Enamel Repairsodium fluorideSodium fluoride .15 g/100g; Potassium nitrate 5 g/100gPaste, DentifriceOralCVS51316-169
Ricola Max Nasal Care Cool MentholmentholMenthol 15.3 mg/1LozengeOralRicola Ag54305-206
Orajel Medicated for Toothache and Gum, Liquidbenzocaine and mentholBenzocaine 200 mg/mL; Menthol, Unspecified form 1 mg/mLLiquidTopicalChurch & Dwight Co., Inc.10237-796
Throat Balm Caramel PectinpectinPectin 3.8 mg/1LozengeOralRicola Ag54305-301
Throat Balm Caramel PectinpectinPectin 3.8 mg/1LozengeOralRicola USA Inc.63667-301
Hydrogen Peroxide 3 Percenthydrogen peroxideHydrogen peroxide 2.65 mL/100mLLiquidTopicalWhole Foods Market42681-6414
Sore throat cherryphenolPhenol 1.4 g/100mLSprayOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-376
Crest Pro-Health Gum DetoxifyWinter Mintcetylpyridinium chlorideCetylpyridinium chloride .07 g/mLRinseOralThe Procter & Gamble Manufacturing Company84126-648
Crest Kids Advanced Color Changingsodium monofluorophosphateSodium monofluorophosphate 1.6 mg/gPaste, DentifriceDentalProcter & Gamble Manufactura, S de R.L. de C.V.58933-012
Sootheez Berry LemonadepectinPectin 11.5 mg/3.5gLozengeOralBFY LLC72427-4014
Sootheez Organic Wild CherrypectinPectin 11.5 mg/3.5gLozengeOralBFY LLC72427-3714
Quality Choice Oral Pain Reliefbenzocaine 20%, benzalkonium chloride 1%Benzocaine 200 mg/g; Benzalkonium chloride 10 mg/gGelTopicalQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)83324-035
Rite Aid Professional StrengthbenzocaineBenzocaine 20 g/100gLiquidOralRite Aid11822-5340
SENSODYNE Rapid Reliefstannous fluorideStannous fluoride 1.1 mg/gPasteOralHaleon US Holdings LLC0135-0622
Iodent Oral AnalgesicbenzocaineBenzocaine 200 mg/gGelTopicalUnited Exchange Corp.65923-094
Sootheez Organic Wild CherrypectinPectin 11.5 mg/3.5gLozengeOralBFY LLC72427-3714
Topcare Sore Throat Menthol FlavorphenolPhenol 1.4 g/100mLSprayOralTOPCO ASSOCIATES LLC36800-606
Sensodyne Pronamel Gentle Whitening Advancedpotassium nitrate and sodium fluoridePotassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/gPasteDentalHaleon US Holdings LLC0135-0580

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