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 38 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Moon Charcoal Whitening Anticavity	SODIUM FLUORIDE	Moon Oral Care, LLC	0c55f7b3-fea1-58f3-e063-6394a90a3bde	2023-12-12	Warnings	Exact identifier application number: M022
ORCA Complete Menthol Pain Reliever	MENTHOL	ORCA Products, LLC	99990e27-d66b-4d61-97f2-6a76066eb8b8	2023-12-08	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	0070858b-e02e-431f-a7c2-313fef01791b	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	d1802f08-80cb-41dd-b34d-9c576b101ddb	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	80182c43-100f-4b15-a07e-819599ab9562	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	c19e6426-8f1e-47b3-a3a6-551a5bec6cd9	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	1f8431bb-f33c-4fd8-9472-9b59ffb5f18e	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	1163d248-d648-443e-bed0-ccb7fd26ba63	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	88caabe2-a096-44d0-98d3-afad1935c012	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	c1b02a2f-db1f-44f0-a74a-d02c085c5bd7	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	39081585-fe6a-4ba1-93f8-d92d26fe75bc	2023-12-07	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d7c69357-795c-03d8-e053-2a95a90a03a6	2023-12-06	Warnings	Exact identifier application number: M022
Dr. Sheffield Sensitive Care	SENSITIVE TOOTH PASTE	Sheffield Pharmaceuticals LLC	702a0dec-64cf-4834-8d80-f3d4f0c08a3a	2023-11-30	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	f3bf106c-5320-ced2-e053-2a95a90a71ac	2023-11-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0b517321-25ed-2676-e063-6294a90ab4c9	2023-11-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0b51b67c-03ac-5730-e063-6394a90a5060	2023-11-29	Warnings	Exact identifier application number: M022
Pearl White	POTASSIUM NITRATE, SODIUM FLUORIDE	Beyond International Inc.	51c79544-9536-5863-e054-00144ff8d46c	2023-11-28	Warnings	Exact identifier application number: M022
UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE	POTASSIUM NITRATE AND SODIUM FLUORIDE	Universal Distribution Center LLC	fcf59439-7e06-4129-a89f-cdeecdf8d488	2023-11-17	Warnings	Exact identifier application number: M022
PerioRestore	HYDROGEN PEROXIDE	DEN-MAT HOLDINGS, LLC.	97a07c36-1af8-a636-e053-2a95a90ad6db	2023-11-13	Warnings	Exact identifier application number: M022
Wild Horse 777 Oral	PHENOL	Wild Horse 777, Inc.	b0b517bb-969f-0c65-e053-2995a90a48b1	2023-11-10	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