What is NDC 0135-0520?

0135-0520 is the product NDC for SENSODYNE PRONAMEL Fresh Breath, Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g paste, listed with the FDA by Haleon US Holdings LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

SENSODYNE PRONAMEL Fresh Breath (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 PRONAMEL Fresh Breath?

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 PRONAMEL Fresh Breath NDC 0135-0520

NDC codes

FDA NDC Directory

Product NDC (as listed)0135-0520Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00135-0520Add 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
0135-0520-01	0013505200100135052001	1 TUBE in 1 CARTON (0135-0520-01) / 113 g in 1 TUBEMarketed from Apr 14, 2011
0135-0520-02	0013505200200135052002	23 g in 1 TUBE (0135-0520-02)Marketed from Apr 14, 2011
0135-0520-05	0013505200500135052005	2 TUBE in 1 CARTON (0135-0520-05) / 113 g in 1 TUBEMarketed from Apr 14, 2011
0135-0520-06	0013505200600135052006	1 TUBE in 1 CARTON (0135-0520-06) / 77 g in 1 TUBEMarketed from Mar 20, 2015

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 PRONAMEL Fresh BreathSuffix: Fresh Breath
Generic name (nonproprietary): potassium nitrate and sodium fluoride
Active ingredients: Potassium nitrate — 50 mg/gSodium fluoride — 1.15 mg/g
Dosage form: Paste
Route: Oral
Labeler: Haleon US Holdings LLCNDC labeler code 0135
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 022
Marketing start: Apr 14, 2011
Listing expires: Dec 31, 2026
Identifiers: Product ID 0135-0520_0fb8d5cd-17d5-f0ac-e063-6394a90ab28dSPL ID 0fb8d5cd-17d5-f0ac-e063-6394a90ab28dSPL set ID edffce4d-108b-4ffd-9adf-e12cb42ffdddRxCUI 1086243UNII 8ZYQ1474W7, RU45X2JN0Z

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

N400135052001 followed by a unit qualifier and the quantity

Package 00135-0520-01. 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 Jan 24, 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 0135-0520

What is NDC 0135-0520?: 0135-0520 is the product NDC for SENSODYNE PRONAMEL Fresh Breath, Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g paste, listed with the FDA by Haleon US Holdings LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: SENSODYNE PRONAMEL Fresh Breath (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 PRONAMEL Fresh Breath?: 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
Hydrogen Peroxide 3 Percent ReadyInCasehydrogen peroxide	Hydrogen peroxide 3 mL/100mL	LiquidTopical	P & L Development, LLC	49580-0268
Salinenasal	Sodium chloride 6.5 mg/mL	SprayNasal	Bi-Mart	37835-998
CVS Health Sensitive Enamel Repairsodium fluoride	Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g	Paste, DentifriceOral	CVS	51316-169
Ricola Max Nasal Care Cool Mentholmenthol	Menthol 15.3 mg/1	LozengeOral	Ricola Ag	54305-206
Orajel Medicated for Toothache and Gum, Liquidbenzocaine and menthol	Benzocaine 200 mg/mL; Menthol, Unspecified form 1 mg/mL	LiquidTopical	Church & Dwight Co., Inc.	10237-796
Throat Balm Caramel Pectinpectin	Pectin 3.8 mg/1	LozengeOral	Ricola Ag	54305-301
Throat Balm Caramel Pectinpectin	Pectin 3.8 mg/1	LozengeOral	Ricola USA Inc.	63667-301
Hydrogen Peroxide 3 Percenthydrogen peroxide	Hydrogen peroxide 2.65 mL/100mL	LiquidTopical	Whole Foods Market	42681-6414
Sore throat cherryphenol	Phenol 1.4 g/100mL	SprayOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-376
Crest Pro-Health Gum DetoxifyWinter Mintcetylpyridinium chloride	Cetylpyridinium chloride .07 g/mL	RinseOral	The Procter & Gamble Manufacturing Company	84126-648
Crest Kids Advanced Color Changingsodium monofluorophosphate	Sodium monofluorophosphate 1.6 mg/g	Paste, DentifriceDental	Procter & Gamble Manufactura, S de R.L. de C.V.	58933-012
Sootheez Berry Lemonadepectin	Pectin 11.5 mg/3.5g	LozengeOral	BFY LLC	72427-4014
Sootheez Organic Wild Cherrypectin	Pectin 11.5 mg/3.5g	LozengeOral	BFY LLC	72427-3714
Quality Choice Oral Pain Reliefbenzocaine 20%, benzalkonium chloride 1%	Benzocaine 200 mg/g; Benzalkonium chloride 10 mg/g	GelTopical	Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)	83324-035
Rite Aid Professional Strengthbenzocaine	Benzocaine 20 g/100g	LiquidOral	Rite Aid	11822-5340
SENSODYNE Rapid Reliefstannous fluoride	Stannous fluoride 1.1 mg/g	PasteOral	Haleon US Holdings LLC	0135-0622
Iodent Oral Analgesicbenzocaine	Benzocaine 200 mg/g	GelTopical	United Exchange Corp.	65923-094
Sootheez Organic Wild Cherrypectin	Pectin 11.5 mg/3.5g	LozengeOral	BFY LLC	72427-3714
Topcare Sore Throat Menthol Flavorphenol	Phenol 1.4 g/100mL	SprayOral	TOPCO ASSOCIATES LLC	36800-606
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

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SENSODYNE PRONAMEL Fresh Breath (Potassium nitrate and sodium fluoride) NDC 0135-0520