parodontax

Product NDC: 0135-0637
11-digit product format: 001350637
Labeler code: 0135
Product ID: 0135-0637_1286328e-795c-46dc-b43d-1257607f3f2f
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: 2021-01-04
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	0135-0637		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0135-0637	0135-0637-02	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0135-0637	0135-0637-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: parodontax
Brand name suffix: Active Gum Repair
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
b51ccdd9-c0af-4caa-ad97-ad1d1423b76b	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0135-0637-01	2024-01-30	Drug Facts
0135-0637-02	2024-01-30	Drug Facts
0135-0637-01	2023-02-10	Drug Facts
0135-0637-02	2023-02-10	Drug Facts
0135-0637-01	2022-07-29	Drug Facts
0135-0637-02	2022-07-29	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0135-0637-01	parodontaxActive Gum Repair	1 in 1 CARTON	PASTE	1	7
0135-0637-01	parodontaxActive Gum Repair	96.4 g in 1 TUBE	PASTE	96.4	7
0135-0637-02	parodontaxActive Gum Repair	1 in 1 CARTON	PASTE	1	7
0135-0637-02	parodontaxActive Gum Repair	22.7 g in 1 TUBE	PASTE	22.7	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0637	PARODONTAX ACTIVE GUM REPAIR (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]	6	Current NDC, Legacy NDC, 4 package rows	20250410_b51ccdd9-c0af-4caa-ad97-ad1d1423b76b.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 21 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry	FLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRY	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	3573f149-2af9-4c86-e063-6294a90a7b3f	2025-05-18	Warnings	Exact identifier application number: M022
Bubble Gum Flavor For Kids 25g 50g	BUBBLE GUM FLAVOR TOOTHPASTE FOR KIDS 25G 50G	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	354c1eda-ec5b-a8c7-e063-6294a90a871d	2025-05-16	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Safeway, Inc.	8fe2f1df-3264-455d-b62c-953dce171c02	2025-05-16	Warnings	Exact identifier application number: M022
Parodontax Active Gum Health Daily Mouthwash Breath Freshener	CETYLPYRIDINIUM CHLORIDE	Haleon US Holdings LLC	32b632bf-058d-447b-a7fb-a9dd05c1e2b8	2025-05-08	Warnings	Exact identifier application number: M022
Parodontax Active Gum Health Clear Mint	CETYLPYRIDINIUM CHLORIDE	Haleon US Holdings LLC	444f931d-5e38-4cda-97ba-98aa0b5fe4f6	2025-05-08	Warnings	Exact identifier application number: M022
Listerine Clinical Solutions Gum Health Icy Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	06e1122b-1100-43c0-e063-6394a90a2e78	2025-04-22	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Strategic Sourcing Services LLC	5260258a-bb1e-43d6-bce1-70a38778a64a	2025-04-14	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	TARGET Corporation	93d0bb3a-51d3-44c8-8fb7-bdb82adfbb65	2025-04-14	Warnings	Exact identifier application number: M022
Listerine Ultraclean Antiseptic Cool Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	ee467ec4-bd5e-644a-e053-2a95a90ac273	2025-04-10	Warnings	Exact identifier application number: M022
Mouthwash	MENTHOL, METHYL SALICYLATE, THYMOL	Orazen Inc	873c43df-1d46-359b-e053-2a91aa0a4319	2025-04-07	Warnings	Exact identifier application number: M022
Sensodyne Complete Protection Extra Fresh	STANNOUS FLUORIDE	Haleon US Holdings LLC	e3cc3146-8aed-4f6b-a252-e379418c2b8d	2025-03-26	Warnings	Exact identifier application number: M022
Listerine Freshburst Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	ee1e1df9-74c6-d24b-e053-2a95a90a43d3	2025-03-04	Warnings	Exact identifier application number: M022
Listerine Cool Mint Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	edb9e374-4dba-5823-e053-2a95a90a3da5	2025-03-03	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Good Sense (Geiss, Destin & Dunn, Inc.)	cfe9be26-e4a4-413c-a602-2f5948e3bb7a	2025-03-03	Warnings	Exact identifier application number: M022
LISTERINE Original Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	78e2e172-09a4-4bf1-9871-d099c49087be	2025-02-28	Warnings	Exact identifier application number: M022
WHITE GLO CHARCOAL SENSITIVE	POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	a5edb7fd-c637-5447-e053-2995a90a5a6f	2025-02-26	Warnings	Exact identifier application number: M022
Glorysmile Toothpaste.	GLORYSMILE TOOTHPASTE.	Jiangxi Dentalbright Technology Co., Ltd	2ef48156-904d-e42a-e063-6394a90a3cd0	2025-02-25	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Walgreens	c4e76d1d-1cee-4eeb-a2e4-6e9b1cac56fa	2025-02-21	Warnings	Exact identifier application number: M022
Sheffield Pain Relief	BENZOCAINE	Sheffield Pharmaceuticals LLC	e21abfdd-373d-42af-9535-fe1571382a65	2025-02-19	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Whole Foods Market	a2bb142e-8cbe-481e-bf4f-810ca6d14591	2025-02-12	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	b51ccdd9-c0af-4caa-ad97-ad1d1423b76b	7
416784	stannous fluoride 0.00454 MG/MG Toothpaste	SCD	b51ccdd9-c0af-4caa-ad97-ad1d1423b76b	7
416784	stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste	SY	b51ccdd9-c0af-4caa-ad97-ad1d1423b76b	7
416784	stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste	SY	b51ccdd9-c0af-4caa-ad97-ad1d1423b76b	7
416784	stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste	SY	b51ccdd9-c0af-4caa-ad97-ad1d1423b76b	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0135-0637-01	00135063701	1 TUBE in 1 CARTON (0135-0637-01) / 96.4 g in 1 TUBE	1 tube	2021-01-04	0000-00-00	No	No	Current
0135-0637-02	00135063702	1 TUBE in 1 CARTON (0135-0637-02) / 22.7 g in 1 TUBE	1 tube	2021-01-04	0000-00-00	No	No	Current