What is NDC 0135-0643?

0135-0643 is the product NDC for Sensodyne Extra Whitening Cool Mint, Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g paste, listed with the FDA by Haleon US Holdings LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Sensodyne Extra Whitening Cool Mint (Potassium nitrate and sodium fluoride).

What is the active ingredient?

Potassium nitrate, Sodium fluoride.

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 Sensodyne Extra Whitening Cool Mint?

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.

Sensodyne Extra Whitening Cool Mint NDC 0135-0643

NDC codes

FDA NDC Directory

Product NDC (as listed)0135-0643Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00135-0643Add 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 NDC	11-digit (billing)	Package	Copy
0135-0643-01	0013506430100135064301	1 TUBE in 1 CARTON (0135-0643-01) / 113 g in 1 TUBEMarketed from Apr 3, 2023

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): Sensodyne Extra Whitening Cool MintSuffix: Extra Whitening Cool Mint
Generic name (nonproprietary): potassium nitrate and sodium fluoride
Active ingredients: Potassium nitrate — 50 mg/gSodium fluoride — 1.15 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: Apr 3, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 0135-0643_12d8be79-e302-098d-e063-6394a90aa50dSPL ID 12d8be79-e302-098d-e063-6394a90aa50dSPL set ID c977f2c4-e0f3-44d2-aa7a-845f0583af3eRxCUI 1038929UNII RU45X2JN0Z, 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

N400135064301 followed by a unit qualifier and the quantity

Package 00135-0643-01. 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 Mar 4, 2024.

Indications (excerpt from the label)

Uses builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. 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 0135-0643

What is NDC 0135-0643?: 0135-0643 is the product NDC for Sensodyne Extra Whitening Cool Mint, Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g paste, listed with the FDA by Haleon US Holdings LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sensodyne Extra Whitening Cool Mint (Potassium nitrate and sodium fluoride).
What is the active ingredient?: Potassium nitrate, 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 Sensodyne Extra Whitening Cool Mint?: 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
Product	Strength	Form · route	Labeler	Product NDC
Oral Gel Oral Pain Reliefbenzocaine benzalkonium chloride	Benzocaine 20 g/100g; Benzalkonium chloride .1 g/100g	GelTopical	Savvy Care and Cosmetics	83650-101
Boka Sensitivepotassium nitrate	Potassium nitrate 5 g/100g	Paste, DentifriceDental	Karaka LLC	87161-444
Sensodyne Pronamel Gentle Whitening Advancedpotassium nitrate and sodium fluoride	Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g	PasteDental	Haleon US Holdings LLC	0135-0580
Lolleez Variety Packpectin	Pectin 11.5 mg/7g	LozengeOral	BFY LLC	72427-3195
UltraCare Anesthetic Gelbenzocaine	Benzocaine 200 mg/g	GelDental, Periodontal, Topical	The Bellport Company, Inc. dba Gingi-Pak	10129-071
Chloraseptic Childrens Sore Throat Cherryphenol	Phenol 1.4 g/100mL	SprayOral	Prestige Brands Holdings, Inc.	67172-930
Quality Choicebenzocaine	Benzocaine 200 mg/g	GelTopical	Chain Drug Marketing Association, Inc.	83324-299
Chloraseptic Sore Throat Maxphenol and glycerin	Phenol 15 mg/mL; Glycerin 330 mg/mL	SprayOral	Prestige Brands Holdings, Inc.	67172-937
Orajel 3X Medicated For Toothache and Gumbenzocaine, menthol, zinc chloride	Menthol 2.6 mg/g + 2 more ingredients	GelTopical	Church & Dwight Co., Inc.	10237-790
SENSODYNE Rapid Reliefstannous fluoride	Stannous fluoride 1.1 mg/g	PasteOral	Haleon US Holdings LLC	0135-0622
Antisepticeucalyptol, menthol, methyl salicylate, thymol	Eucalyptol .92 mg/mL + 3 more ingredients	LiquidOral	WALMART INC. (see also Equate)	79903-151
Pearson Topical Anestheticbenzocaine	Benzocaine 200 mg/g	GelDental	Pearson Dental Supplies INC.	43305-0008
Mucinex Instasoothe Sore Throat Plus Pain Reliefbenzocaine and menthol, unspecified form	Benzocaine 7 g/100mL; Menthol, Unspecified form 1 g/100mL	SprayOral	Reckitt Benckiser LLC	72854-265
HEB Extra Whiteningfluoride	Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g	Paste, DentifriceDental	HEB	37808-961
Pearson Topical Anestheticbenzocaine	Benzocaine 200 mg/g	GelDental	Pearson Dental Supplies INC.	43305-0005
Mucinex Instasoothe Sore Throat Plus Pain Reliefhexylresorcinol	Hexylresorcinol 2 mg/1	LozengeOral	Reckitt Benckiser LLC	72854-262
Crest Scope Originalcetylpyridinium chloride	Cetylpyridinium chloride .014 g/mL	RinseOral	The Procter & Gamble Manufacturing Company	84126-602
Pearson Topical Anestheticbenzocaine	Benzocaine 200 mg/g	GelDental	Pearson Dental Supplies INC.	43305-0006
HurriCaine Topical Anestheticbenzocaine	Benzocaine 200 mg/g	GelDental, Oral, Periodontal	Beutlich Pharmaceuticals, LLC	0283-0920
Pearson Topical Anestheticbenzocaine	Benzocaine 200 mg/g	GelDental	Pearson Dental Supplies INC.	43305-0007

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Sensodyne Extra Whitening Cool Mint (Potassium nitrate and sodium fluoride) NDC 0135-0643