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 7 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lemon Glycerin	GLYCERIN	Dynarex Corporation	99fc00ea-9d55-0380-e053-2995a90a2c0b	2026-03-24	Warnings	Exact identifier application number: M022
Dual-FormulaToothpaste for sensitive teeth	DUAL-FORMULA TOOTHPASTE FOR SENSITIVE TEETH	Hangzhou Namei Zhikang Technology Co., Ltd.	4d735f91-8abc-3a30-e063-6394a90a7639	2026-03-20	Warnings	Exact identifier application number: M022
SmileCare Mouth Ulcer Gel	MENTHOL	Yantai Aien Biotechnology Co., Ltd.	4d6db039-5b97-8f3f-e063-6294a90a9d85	2026-03-19	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f91e609-8ca5-0492-e053-2a95a90a85d0	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f81ffa5-05fd-4eef-e053-2995a90aac3e	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f947366-9380-3fa9-e053-2a95a90ad49c	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f947672-4873-5546-e053-2a95a90a3c4b	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f9490c1-8bfe-3166-e053-2a95a90a7175	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f94b65d-47e3-9c6b-e053-2a95a90aa1f8	2026-03-17	Warnings	Exact identifier application number: M022
BencoCaine Topical Anesthetic	BENZOCAINE	Benco Dental	4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b	2026-03-17	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043c00a6-1346-7780-e063-6294a90a3d5a	2026-03-12	Warnings	Exact identifier application number: M022
ORAL PAIN RELIEF	BENZOCAINE	Nantong Health & Beyond Hygienic Products Inc.	a5f0be98-d47e-4307-8044-304a64db774b	2026-03-11	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	a2f9d58b-671b-4427-a971-1fceff5f2323	2026-03-09	Warnings	Exact identifier application number: M022
Sore Mouth Cleanser	HYDROGEN PEROXIDE	CVS Pharmacy, Inc.	a5dbaadf-76a8-4c48-af2d-f4455e9411f0	2026-03-09	Warnings, Adverse reactions	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Sam's West, Inc	78a3e024-73da-40b7-9d9c-099fd6ca9b9e	2026-03-03	Warnings	Exact identifier application number: M022
Sore Throat	PHENOL GLYCERIN	CVS PHARMACY, INC	9683bcfb-2f7e-48a4-aa79-500ee8df099a	2026-03-02	Warnings	Exact identifier application number: M022
Spring Gene Oil Pulling Sensitivity	POTASSIUM NITRATE	Health and Natural Beauty USA Corp	294051e3-69ec-4190-8b03-fa34988376b7	2026-02-26	Warnings	Exact identifier application number: M022
Lolleez Watermelon	PECTIN	BFY LLC	4ba8af8b-5a17-8b8c-e063-6394a90a63f3	2026-02-25	Warnings	Exact identifier application number: M022
Oral Sore Antiseptic	HYDROGEN PEROXIDE, MENTHOL	H E B	f1450866-1be4-46d9-9fe4-52d699636b4f	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M022
SIGNATURE CARE SORE THROAT CHERRY FLAVOR	PHENOL	SAFEWAY	94a2c1b9-f462-4489-b84a-825a82835d30	2026-02-23	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