FDA.reportPublic FDA data

HIMALAYA PINK SALT Intensive Whitening Spearmint

Product NDC
43136-591
11-digit product format
431360591
Labeler code
43136
Product ID
43136-591_14eb9f74-e5f6-e199-e063-6394a90adbf6
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Tai Guk Pharma. Co., Ltd.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-29
Substance
SODIUM FLUORIDE
Active strength
1.5 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HIMALAYA PINK SALT Intensive Whitening Spearmint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui891775

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43136-591-20HIMALAYA PINK SALT Intensive Whitening Spearmint120 g in 1 TUBEPASTE, DENTIFRICE1201
43136-591-20HIMALAYA PINK SALT Intensive Whitening Spearmint1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43136-591HIMALAYA PINK SALT INTENSIVE WHITENING SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [TAI GUK PHARMA. CO., LTD.]1Current NDC, 2 package rows20240401_14eb9f74-e5f5-e199-e063-6394a90adbf6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN14eb9f74-e5f5-e199-e063-6394a90adbf61
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD14eb9f74-e5f5-e199-e063-6394a90adbf61
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY14eb9f74-e5f5-e199-e063-6394a90adbf61
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY14eb9f74-e5f5-e199-e063-6394a90adbf61
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY14eb9f74-e5f5-e199-e063-6394a90adbf61
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY14eb9f74-e5f5-e199-e063-6394a90adbf61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43136-591-20431360591201 TUBE in 1 CARTON (43136-591-20) / 120 g in 1 TUBE1 tube2024-03-29NoNoHistorical