parodontax

Product NDC: 0135-0599
11-digit product format: 001350599
Labeler code: 0135
Product ID: 0135-0599_6c2a1049-455b-40ac-b241-2b15364f527c
Type: HUMAN OTC DRUG
Nonproprietary name: stannous fluoride
Dosage form: PASTE
Route: DENTAL
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application: part356
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2016-12-19
Marketing end: 0000-00-00
Substance: STANNOUS FLUORIDE
Active strength: 1 mg/g
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0135-0599		D	Discontinued by firm	2026-08-11
excluded package	package	0135-0599	0135-0599-01	D	Discontinued by firm	2026-08-11
excluded package	package	0135-0599	0135-0599-02	D	Discontinued by firm	2026-08-11

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 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0135-0599-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0135-0599-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0135-0599-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0135-0599-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0135-0599-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0135-0599-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0135-0599-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0135-0599-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0135-0599-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0135-0599-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0135-0599-02	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0135-0599-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0135-0599-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0135-0599-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0135-0599-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0135-0599-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0135-0599-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0135-0599-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0135-0599-02	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0135-0599-01	2024-01-30	Drug Facts
0135-0599-02	2024-01-30	Drug Facts
0135-0599-01	2023-02-10	Drug Facts
0135-0599-02	2023-02-10	Drug Facts
0135-0599-01	2022-07-29	Drug Facts
0135-0599-02	2022-07-29	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0135-0599-01	parodontax	23 g in 1 TUBE	PASTE	23	12
0135-0599-01	parodontax	1 in 1 CARTON	PASTE	1	12
0135-0599-02	parodontax	1 in 1 CARTON	PASTE	1	12
0135-0599-02	parodontax	96.4 g in 1 TUBE	PASTE	96.4	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0135-0599-02	GM - Gram	0135-0599	64f30c3e-83fa-481b-b140-03bc80bb5cf7	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0599	PARODONTAX (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]	11	Legacy NDC, 4 package rows	20250424_0f07aa1a-97be-44af-92d8-a10777e24e0a.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
parodontax	STANNOUS FLUORIDE	Haleon US Holdings LLC	0f07aa1a-97be-44af-92d8-a10777e24e0a	2025-12-22	Warnings	Exact identifier ndc (product): 0135-0599

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	0f07aa1a-97be-44af-92d8-a10777e24e0a	12
416784	stannous fluoride 0.00454 MG/MG Toothpaste	SCD	0f07aa1a-97be-44af-92d8-a10777e24e0a	12
416784	stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste	SY	0f07aa1a-97be-44af-92d8-a10777e24e0a	12
416784	stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste	SY	0f07aa1a-97be-44af-92d8-a10777e24e0a	12
416784	stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste	SY	0f07aa1a-97be-44af-92d8-a10777e24e0a	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0135-0599-01	00135059901	23 g in 1 TUBE	23 g					Historical
0135-0599-02	00135059902	1 TUBE in 1 CARTON (0135-0599-02) > 96.4 g in 1 TUBE	1 tube	2016-12-19	0000-00-00	No	No	Current