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 18 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Listerine Essential Care	SODIUM MONOFLUOROPHOSPHATE	Kenvue Brands LLC	90b5c3d8-baa4-44ab-8f73-e177007f0219	2025-10-10	Warnings	Exact identifier application number: M022
DuoCare Clinical Oral Rinse	CETYLPYRIDINIUM CHLORIDE	Medline Industries, LP	98e61cd5-7e29-7066-e053-2a95a90afa21	2025-10-10	Warnings	Exact identifier application number: M022
4-in-1 Teeth Care Pens	4-IN-1 TEETH CARE PENS	Jiangxi Dentalbright Technology Co., Ltd	40b756b7-ce1b-6482-e063-6294a90a0425	2025-10-09	Warnings	Exact identifier application number: M022
Giltuss Bucalsep	BENZOCAINE, MENTHOL, ZINC CHLORIDE	Gil Pharmaceutical Corp	85053391-8d71-ab4f-e053-2991aa0a7e08	2025-10-09	Warnings	Exact identifier application number: M022
Listerine Gum Therapy Mouthwash Glacier Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	40a0bdf3-1698-1449-e063-6394a90ab13d	2025-10-08	Warnings	Exact identifier application number: M022
Kalaya Breath Refresh	MOUTHWASH	Avaria Health and Beauty Corp	750e99ff-72e4-3c2f-e053-2a91aa0ad5a0	2025-10-08	Warnings	Exact identifier application number: M022
Trader Joes	SODIUM FLUORIDE 0.24% AND POTASSIUM NITRATE 5%	TRADER JOE'S COMPANY	159abeba-6da2-2643-e063-6394a90a730d	2025-10-08	Warnings	Exact identifier application number: M022
Family Wellness Oral Pain Relief	BENZOCAINE 20%	FAMILY DOLLAR SERVICES INC	105d87d6-9147-43d4-e063-6394a90a57ee	2025-10-08	Warnings	Exact identifier application number: M022
Equate Glistening Mint	SODIUM FLUORIDE	Walmart Inc.	39ff21ee-a362-014e-e063-6294a90a0d91	2025-10-03	Warnings	Exact identifier application number: M022
Mouth Sore Relief Professional Strength	BENZOCAINE	CVS Pharmacy	1b7209f6-8368-47fa-8df2-b049613b8c1b	2025-09-30	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Family Dollar (FAMILY WELLNESS)	9db73da2-5b70-41e6-bcf9-caa7f1142024	2025-09-29	Warnings	Exact identifier application number: M022
Esunix Oral Bacteriostatic Liquid	CETYLPYRIDINIUM CHLORIDE	Xiling (Zhenjiang) Medical Technology Co., Ltd.	3f47d7e1-b6ae-efd1-e063-6394a90a4602	2025-09-27	Warnings	Exact identifier application number: M022
Chloraseptic Sore Throat Cherry	PHENOL	Prestige Brands Holdings, Inc.	d5d62f7a-8f92-4d42-a2fb-691f896f72fc	2025-09-26	Warnings	Exact identifier application number: M022
Giltuss Bucalsep	BENZOCAINE, MENTHOL, ZINC CHLORIDE	Dextrum Laboratories Inc.	3fa233dc-156c-1e95-e063-6294a90a8bbd	2025-09-25	Warnings	Exact identifier application number: M022
Finafta MultiOral	BENZOCAINE	Dextrum Laboratories Inc.	cb027ab8-4175-4cc0-a73e-991dfb113df9	2025-09-23	Warnings	Exact identifier application number: M022
4-in-1 Teeth Care Pens	4-IN-1 TEETH CARE PENS	Jiangxi Dentalbright Technology Co., Ltd	3f872924-0c44-267b-e063-6394a90a1a67	2025-09-23	Warnings	Exact identifier application number: M022
Dental Relief	BENZOCAINE	Cintas Corporation	0f40f775-797e-43cf-88c9-00eea666494f	2025-09-23	Warnings	Exact identifier application number: M022
Seavue Anti-caries Gel	SODIUM FLUORIDE	Xiling (Zhenjiang) Medical Technology Co., Ltd.	3f4c6086-b96d-8fa4-e063-6294a90ad800	2025-09-21	Warnings	Exact identifier application number: M022
Seavue Dental Desensitizer	POTASSIUM NITRATE AND SODIUM FLUORIDE DENTIFRICE	Xiling (Zhenjiang) Medical Technology Co., Ltd.	3f47f399-1a14-5264-e063-6394a90aeb1c	2025-09-20	Warnings	Exact identifier application number: M022
Povi-One	POVIDONE-IODINE 10% TOPICAL	Elevate Oral Care	27c29a33-d1cc-d72f-e063-6394a90a4d45	2025-09-19	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