FDA.reportPublic FDA data

Charm-Tex FLUORIDE

Product NDC
77573-011
Requested package NDC
77573-011-02
11-digit product format
775730011
Labeler code
77573
Product ID
77573-011_e391a678-d68f-9317-e053-2995a90a90e7
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
TOPICAL
Labeler
Jiangsu Aimeili Cosmetic Co.,Ltd.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-07-10
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
0 g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage77573-01177573-011-02IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
77573-011-0177573-011
77573-011-0277573-011
77573-011-0377573-011
77573-011-0477573-011
77573-011-0577573-011
77573-011-0677573-011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77573-011-01Charm-Tex FLUORIDE720 in 1 PACKAGEPASTE, DENTIFRICE7202
77573-011-01Charm-Tex FLUORIDE17 g in 1 TUBEPASTE, DENTIFRICE172
77573-011-02Charm-Tex FLUORIDE720 in 1 PACKAGEPASTE, DENTIFRICE7202
77573-011-02Charm-Tex FLUORIDE24 g in 1 TUBEPASTE, DENTIFRICE242
77573-011-03Charm-Tex FLUORIDE43 g in 1 TUBEPASTE, DENTIFRICE432
77573-011-03Charm-Tex FLUORIDE144 in 1 PACKAGEPASTE, DENTIFRICE1442
77573-011-04Charm-Tex FLUORIDE78 g in 1 TUBEPASTE, DENTIFRICE782
77573-011-04Charm-Tex FLUORIDE144 in 1 PACKAGEPASTE, DENTIFRICE1442
77573-011-05Charm-Tex FLUORIDE60 in 1 PACKAGEPASTE, DENTIFRICE602
77573-011-05Charm-Tex FLUORIDE130 g in 1 TUBEPASTE, DENTIFRICE1302
77573-011-06Charm-Tex FLUORIDE60 in 1 PACKAGEPASTE, DENTIFRICE602
77573-011-06Charm-Tex FLUORIDE181 g in 1 TUBEPASTE, DENTIFRICE1812

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77573-011CHARM-TEX FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [JIANGSU AIMEILI COSMETIC CO.,LTD.]2Legacy NDC, 12 package rows20240105_9b09e4d1-bf48-4cec-b2a4-e43409cc65e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN9b09e4d1-bf48-4cec-b2a4-e43409cc65e52
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD9b09e4d1-bf48-4cec-b2a4-e43409cc65e52
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY9b09e4d1-bf48-4cec-b2a4-e43409cc65e52
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY9b09e4d1-bf48-4cec-b2a4-e43409cc65e52
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY9b09e4d1-bf48-4cec-b2a4-e43409cc65e52
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY9b09e4d1-bf48-4cec-b2a4-e43409cc65e52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77573-011-0277573001102720 TUBE in 1 PACKAGE (77573-011-02) > 24 g in 1 TUBE720 tube2022-07-110000-00-00NoNoCurrent