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 10 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Pro-Health Breath Purify and Gum Care	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d71ed31f-cc33-2fc3-e053-2995a90ad39b	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Clinical	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	0a295ee0-55c2-4f21-8f0a-70efc0e51694	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Gum Care	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d721e2cb-8f67-3d07-e053-2995a90ae65a	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Advantage	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	ddcd56fe-25d6-8195-e053-2a95a90a575a	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Bacteria Guard	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	c2dc1f31-625d-a032-e053-2995a90a730d	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro Health Gum plus Bacteria Guard	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	c598a4ab-5981-0068-e053-2a95a90af4fa	2026-01-08	Warnings	Exact identifier application number: M022
Oral B Gum Detoxify Special Care Rinse	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	c2dcdde4-5542-1f87-e053-2995a90a261c	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Intense Fresh Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	62991165-ec81-48a8-e053-2991aa0a54f3	2026-01-08	Warnings	Exact identifier application number: M022
Crest Gum Care	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	72f1a02f-1d02-7e83-e053-2a91aa0a7947	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Intense Clean Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	6287bc3e-8b05-45d3-e053-2991aa0aaa10	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Multi-Protection Refreshing Clean Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	8867d791-7e93-4f39-aaaf-bfbee8296fd9	2026-01-08	Warnings	Exact identifier application number: M022
4x Medicated Toothache and Gum Cream	BENZOCAINE	HEB	a71c5259-cbcf-7566-e053-2995a90a2cb6	2026-01-08	Warnings	Exact identifier application number: M022
Topco Associates LLC Maximum Strength	FLUORIDE	Topco Associates LLC	387d264c-90cc-5e67-e063-6394a90a713d	2026-01-08	Warnings	Exact identifier application number: M022
TopCare Sensitive Extra Whitening	POTASSIUM NITRATE, SODIUM FLUORIDE	TOPCO Assoc. LLC	835f41cf-e920-7df7-e053-2a91aa0a4479	2026-01-08	Warnings	Exact identifier application number: M022
Scope Icy Blast	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	164ed151-01d3-021a-e063-6294a90a0e51	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Advanced Enamel Care	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	1660e7d7-5b8d-8aba-e063-6294a90a50d8	2026-01-08	Warnings	Exact identifier application number: M022
Crest Deep Cleanse Germ Treatment	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	2d6b15d4-7827-ec2f-e063-6294a90a82c8	2026-01-08	Warnings	Exact identifier application number: M022
Crest Scope Original	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	21eed451-9368-146c-e063-6294a90af62b	2026-01-08	Warnings	Exact identifier application number: M022
3x Medicated Mouth Sore Gel	BENZOCAINE	HEB	a71c5259-cbd1-7566-e053-2995a90a2cb6	2026-01-08	Warnings	Exact identifier application number: M022
HEB Extra Whitening	FLUORIDE	HEB	b76c3591-6383-4661-b3db-7a56b11202f7	2026-01-08	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