parodontax

Product NDC: 0135-0598
11-digit product format: 001350598
Labeler code: 0135
Product ID: 0135-0598_c8ed1491-d424-49f6-b49e-56a938dc7328
Type: HUMAN OTC DRUG
Nonproprietary name: stannous fluoride
Dosage form: PASTE
Route: DENTAL
Labeler: Haleon US Holdings LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-12-19
Substance: STANNOUS FLUORIDE
Active strength: 1.1 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	0135-0598		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0135-0598	0135-0598-02	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0135-0598	0135-0598-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

Additional Listing Data#

Finished product: Yes
Brand name base: parodontax
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
STANNOUS FLUORIDE	1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3FTR44B32Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
416784	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0f07aa1a-97be-44af-92d8-a10777e24e0a	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0135-0598-01	2024-01-30	Drug Facts
0135-0598-02	2024-01-30	Drug Facts
0135-0598-01	2023-02-10	Drug Facts
0135-0598-02	2023-02-10	Drug Facts
0135-0598-01	2022-07-29	Drug Facts
0135-0598-02	2022-07-29	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0135-0598-01	parodontax	96.4 g in 1 TUBE	PASTE	96.4	12
0135-0598-01	parodontax	1 in 1 CARTON	PASTE	1	12
0135-0598-02	parodontax	1 in 1 CARTON	PASTE	1	12
0135-0598-02	parodontax	23 g in 1 TUBE	PASTE	23	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0135-0598-01	GM - Gram	0135-0598	c3e0bcda-0825-42d2-b06c-16ef4d35c439	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0598	PARODONTAX (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]	11	Current NDC, Legacy NDC, 4 package rows	20250424_0f07aa1a-97be-44af-92d8-a10777e24e0a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 42 · 825 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Opalescence Whitening Sensitivity Relief	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	44e94663-895b-67da-e063-6394a90a5fe6	2026-09-09	Warnings	Exact identifier application number: M022
Opalescence Sensitivity Relief Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	b5176a84-76a3-4ad0-a2e2-4997a12da9a5	2026-09-09	Warnings	Exact identifier application number: M022
Opal by Opalescence Sensitivity	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	5ffc0d14-0290-47bb-90e5-90a25a5acc28	2026-09-09	Warnings	Exact identifier application number: M022
Saline	NASAL	Raritan Pharmaceuiticals Inc	4b178e4e-a10f-4b75-8140-1f7548e203ad	2026-09-09	Warnings	Exact identifier application number: M022
SORE THROAT	PHENOL	Raritan Pharmaceuticals Inc	43ce374a-824c-4034-bf04-c351b4d8015b	2026-09-08	Warnings	Exact identifier application number: M022
Colgate Optic White Stain Fighter Sens Relief	SODIUM FLUORIDE	Colgate-Palmolive Company	6ec2fff7-df44-4302-be2d-97946c6cd66a	2026-09-08	Warnings	Exact identifier application number: M022
DRx Choice Sore Throat Menthol Flavor	PHENOL	RARITAN PHARMACEUTICALS INC	e3269b12-5c05-45a6-81f2-65d9f016c3aa	2026-09-08	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	AmerisourceBergen (Good Neighbor Pharmacy) 46122	0733015b-e81a-4a62-82ad-dacaf3f163cb	2026-09-02	Warnings	Exact identifier application number: M022
KROGER Saline	NASAL	KROGER COMPANY	c84b242b-f46e-4ea8-a3c1-109a47644646	2026-09-02	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	WALMART INC. (see also Equate)	ceb125d9-8c1b-498c-b0f0-f18756ede442	2026-09-01	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1c82b4-02b3-d456-e063-6294a90a16bb	2026-08-31	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum PM Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1cdaf4-3388-280c-e063-6294a90ac70f	2026-08-31	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORT	HEXYLRESORCINOL	Reckitt Benckiser LLC	91cd2964-5d83-4e40-bc18-e3e5462f454a	2026-08-31	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF	HEXYLRESORCINOL	Reckitt Benckiser LLC	4c150222-06ea-4fcf-967f-84e19846bd66	2026-08-31	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1b4133-0eac-2f8f-e063-6394a90af8f6	2026-08-28	Warnings	Exact identifier application number: M022
LUDENS SUGAR FREE WILD CHERRY THROAT	PECTIN	Prestige Brands Holdings, Inc.	274fc80c-e5b2-41c7-a119-287d6e8a2258	2026-08-28	Warnings	Exact identifier application number: M022
Medline Peroxi Fresh Mouthwash	HYDROGEN PEROXIDE	Medline Industries, LP	ec7a9240-6c66-4471-b8b6-776e08a14fbc	2026-08-27	Warnings	Exact identifier application number: M022
Saline	SALINE NASAL SPRAY	Dynarex Corporation	3247ae7d-554f-baab-e063-6294a90aa3ec	2026-08-25	Warnings	Exact identifier application number: M022
Tumeez Organic Apple	CALCIUM CARBONATE	BFY LLC	f561685a-5260-59c6-e053-2a95a90ae206	2026-08-25	Warnings	Exact identifier application number: M022
Ludens Watermelon Throat Drops	PECTIN	Prestige Brands Holdings, Inc.	adfb248a-96bb-4742-9df6-c47edccdd671	2026-08-20	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3FTR44B32Q	STANNOUS FLUORIDE	7783-47-3	STANNOUS FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
416784	stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste	PSN	0f07aa1a-97be-44af-92d8-a10777e24e0a	12
416784	stannous fluoride 0.00454 MG/MG Toothpaste	SCD	0f07aa1a-97be-44af-92d8-a10777e24e0a	12
416784	stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste	SY	0f07aa1a-97be-44af-92d8-a10777e24e0a	12
416784	stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste	SY	0f07aa1a-97be-44af-92d8-a10777e24e0a	12
416784	stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste	SY	0f07aa1a-97be-44af-92d8-a10777e24e0a	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0135-0598-01	00135059801	1 TUBE in 1 CARTON (0135-0598-01) / 96.4 g in 1 TUBE	1 tube	2016-12-19	0000-00-00	No	No	Current
0135-0598-02	00135059802	1 TUBE in 1 CARTON (0135-0598-02) / 23 g in 1 TUBE	1 tube	2018-05-02	0000-00-00	No	No	Current