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…`

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 1 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrogen Peroxide 3 Percent ReadyInCase	HYDROGEN PEROXIDE	P & L Development, LLC	b0866db5-3b0d-4478-9b3b-1f077d2f5393	2026-08-06	Warnings	Exact identifier application number: M022
Ollie Fresh Mint	SODIUM FLUORIDE, POTASSIUM NITRATE	Brio Product Group LLC.	ebeec44f-3c22-43f2-9256-6ece6025c105	2026-08-06	Warnings	Exact identifier application number: M022
PRO-SYS	ORAL WOUND CLEANSER	Forward Science Technologies LLC	c357c8f8-6fd6-c2f8-e053-2995a90a4023	2026-07-30	Warnings	Exact identifier application number: M022
Lornamead Natural White	FLUORIDE	Lornamead Products	9d7d08d7-8ca4-4b05-8b74-3bfa372b1608	2026-07-29	Warnings	Exact identifier application number: M022
Made by Dentists Enamel 10 Fluoride Anticavity	POTASSIUM NITRATE, SODIUM FLUORIDE	Made By Dentists Inc	3c62eab1-0cb6-4bdf-bfd4-c5afe734d036	2026-07-24	Warnings	Exact identifier application number: M022
Saline	NASAL	BEST CHOICE (VALU MERCHANDISERS COMPANY)	71485e82-bf54-4b8b-8dd2-2a0761534520	2026-07-17	Warnings	Exact identifier application number: M022
Good Neighbor Sore Throat Cherry Flavor	PHENOL	AMERISOURCE BERGEN	aa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f	2026-07-13	Warnings	Exact identifier application number: M022
ABC Sore Throat Menthol Flavor	PHENOL	AMERISOURCE BERGEN	9d9baf58-4790-4ff4-a462-5eb70c0e80c5	2026-07-13	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	P & L Development, LLC	350b5f64-d152-40cb-b22f-98541f0e1b0a	2026-07-09	Warnings	Exact identifier application number: M022
Quality Choice Natural White	FLUORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	561a75c2-a40c-ba7c-e063-6294a90aa119	2026-07-08	Warnings	Exact identifier application number: M022
SALINE NASAL	SODIUM CHLORIDE	ALAINA HEALTHCARE PRIVATE LIMITED	ed30a7f9-7132-42da-9bed-63a9b1c80ab2	2026-07-07	Warnings	Exact identifier application number: M022
Tumeez Organic Apple	CALCIUM CARBONATE	BFY LLC	f561685a-5260-59c6-e053-2a95a90ae206	2026-07-06	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF	HEXYLRESORCINOL	Reckitt Benckiser LLC	4c150222-06ea-4fcf-967f-84e19846bd66	2026-07-03	Warnings	Exact identifier application number: M022
Dental system starter kit	US CONVENIENCE KIT (718907)	Dyson Technology Limited	5355b79b-711f-1a4a-e063-6394a90afc4b	2026-06-30	Warnings	Exact identifier application number: M022
Anticavity and sensitive peppermint	907 US VARIANT ANTICAVITY AND SENSITIVE TOOTHPASTE NON FOAMING PEPPERMINT	Dyson Technology Limited	5332ab71-d994-39cf-e063-6294a90a0d98	2026-06-30	Warnings	Exact identifier application number: M022
NebuClear MD Saline	NEBUCLEAR MD SALINE	Blue Echo Care LLC	55820ff9-7b4b-2bce-e063-6394a90a8b43	2026-06-30	Warnings	Exact identifier application number: M022
NebuClear MD Saline	NEBUCLEAR MD SALINE	Blue Echo Care LLC	55806cb8-cf92-c4e5-e063-6394a90aaa2d	2026-06-30	Warnings	Exact identifier application number: M022
NebuClear MD Saline	NEBUCLEAR MD SALINE	Blue Echo Care LLC	5581d8e5-4105-e9da-e063-6394a90a316e	2026-06-30	Warnings	Exact identifier application number: M022
Corinz	CETYLPYRIDINIUM CHLORIDE	Sage Products, LLC	685b6023-89c4-417e-af2d-52e831855da1	2026-06-29	Warnings	Exact identifier application number: M022
Antiplaque solution	CETYLPYRIDINIUM CHLORIDE	Sage Products LLC	881d4d08-4b45-486a-93af-18c0e00a5b0e	2026-06-29	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