FDA.reportPublic FDA data

HIMALAYA PINK SALT Intensive Whitening Spearmint

Product NDC
53208-591
11-digit product format
532080591
Labeler code
53208
Product ID
53208-591_14ea1776-ef80-27a9-e063-6394a90afd49
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
LG H&H 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
53208-591-20HIMALAYA PINK SALT Intensive Whitening Spearmint1 in 1 CARTONPASTE, DENTIFRICE11
53208-591-20HIMALAYA PINK SALT Intensive Whitening Spearmint120 g in 1 TUBEPASTE, DENTIFRICE1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-591HIMALAYA PINK SALT INTENSIVE WHITENING SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [LG H&H CO.,LTD.]1Current NDC, 2 package rows20240401_14ea1776-ef7f-27a9-e063-6394a90afd49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN14ea1776-ef7f-27a9-e063-6394a90afd491
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD14ea1776-ef7f-27a9-e063-6394a90afd491
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY14ea1776-ef7f-27a9-e063-6394a90afd491
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY14ea1776-ef7f-27a9-e063-6394a90afd491
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY14ea1776-ef7f-27a9-e063-6394a90afd491
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY14ea1776-ef7f-27a9-e063-6394a90afd491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53208-591-20532080591201 TUBE in 1 CARTON (53208-591-20) / 120 g in 1 TUBE1 tube2024-03-29NoNoHistorical