FDA.reportPublic FDA data

parodontax

Product NDC
0135-0599
Requested package NDC
0135-0599-02
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0135-05990135-0599-02DDiscontinued by firm2026-08-11

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 · 7 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0135-0599-012024-01-30Drug Facts
0135-0599-022024-01-30Drug Facts
0135-0599-012023-02-10Drug Facts
0135-0599-022023-02-10Drug Facts
0135-0599-012022-07-29Drug Facts
0135-0599-022022-07-29Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0599-01parodontax23 g in 1 TUBEPASTE2312
0135-0599-01parodontax1 in 1 CARTONPASTE112
0135-0599-02parodontax1 in 1 CARTONPASTE112
0135-0599-02parodontax96.4 g in 1 TUBEPASTE96.412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0599-02GM - Gram0135-059964f30c3e-83fa-481b-b140-03bc80bb5cf712017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0599PARODONTAX (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]11Legacy NDC, 4 package rows20250424_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
parodontaxSTANNOUS FLUORIDEHaleon US Holdings LLC0f07aa1a-97be-44af-92d8-a10777e24e0a2025-12-22WarningsExact identifier
ndc (package): 0135-0599-02
ndc (product): 0135-0599
ndc11 (package): 00135059902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN0f07aa1a-97be-44af-92d8-a10777e24e0a12
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD0f07aa1a-97be-44af-92d8-a10777e24e0a12
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY0f07aa1a-97be-44af-92d8-a10777e24e0a12
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY0f07aa1a-97be-44af-92d8-a10777e24e0a12
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY0f07aa1a-97be-44af-92d8-a10777e24e0a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0599-02001350599021 TUBE in 1 CARTON (0135-0599-02) > 96.4 g in 1 TUBE1 tube2016-12-190000-00-00NoNoCurrent