FDA.reportPublic FDA data

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0599-012024-01-30C16284748780-1e4f33bdf-abcc-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0599-022024-01-30C16284748780-1e4f33bdf-abcc-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0599-012023-02-10C16284748780-1e4f33bdf-abcc-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0599-022023-02-10C16284748780-1e4f33bdf-abcc-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0599-012022-07-29C16284748780-1e4f33bdf-abcc-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0599-022022-07-29C16284748780-1e4f33bdf-abcc-d8a0-e053-dadaa90a6e4eDrug 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

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
0135-0599-010013505990123 g in 1 TUBE23 gHistorical
0135-0599-02001350599021 TUBE in 1 CARTON (0135-0599-02) > 96.4 g in 1 TUBE1 tube2016-12-190000-00-00NoNoCurrent