FDA.reportPublic FDA data

HIMALAYA PINK SALT Intensive Whitening Spearmint

Manufacturer
Tai Guk Pharma. Co., Ltd. | LG H&H Co.,Ltd.
Effective date
2024-03-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:10:26

Label at a glance#

ProductHIMALAYA PINK SALT Intensive Whitening Spearmint
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

adults and children 2 years of age and and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist. ​do not swallow. ​to minimize swallowing use a pea-sized amount in children under 6. ​supervise children's brushing until good habits are established. ​children under 2 years: ask a dentist.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

SODIUM FLUORIDE 0.243%
(0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity
toopaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. Do not swallow.
If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center right away.
If an allergic reaction develops, discontinue use immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist.
  • ​do not swallow.
  • ​to minimize swallowing use a pea-sized amount in children under 6.
  • ​supervise children's brushing until good habits are established.
  • ​children under 2 years: ask a dentist.

Inactive ingredients

INACTIVE INGREDIENT SECTION

GLYCERIN, HYDRATED SILICA, SODIUM HEXAMETAPHOSPHATE, WATER, PEG-6, ZINC STEARATE, COCAMIDOPROPYL BETAINE, FLAVOR, SODIUM LAURYL SULFATE, CARRAGEENAN, POTASSIUM PHOSPHATE (tribasic), TITANIUM DIOXIDE, POTASSIUM PHOSPHATE (monobasic), POLOXAMER 407, SODIUM SACCHARIN, ALGIN, SODIUM CHLORIDE, XANTHAN GUM, SUCRALOSE, XYLITOL, CI 17200, CI 15985

Questions?

OTC - QUESTIONS SECTION

1-86-993-4709

SPL UNCLASSIFIED SECTION

DISTR. LG H&H Co., Ltd.
58, SAEMUNAN-RO, JONGNO-GU, SEOUL, KOREA

MADE IN KOREA

SPL UNCLASSIFIED SECTION

  • Visibly whiter teeth in 1 week**
  • Provides 24 hour stain resistance***
  • Formulated without parabens, gluten, phthalates, triclosan
  • U.S. patented formula***

* Compared to regular toothpaste without SHMP.IADR2024 (in-vitro)
** Clinically proven whitening. Improves 1.42 levels of VITA classic Shade Guide vs. 1 week before
*** 38% higher prevention compared to regular toothpaste without SHMP.IADR2024 (in-vitro)
**** Patent : US 11,701, 313 B2

Principal Display Panel:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HIMALAYA
PINK SALT

Intensive Whitening

fluoride anticavity
toothpaste_ spearmint

9X
WHITER*

CLINICALLY PROVEN**
24HR STAIN RESISTANCE***
ENAMEL STRENGTHENING


NET WT. 4.2 OZ (120 g)

himalaya_pink_salt_intensive_whitening_spearmint_120g_ochimalaya_pink_salt_intensive_whitening_spearmint_120g_oc

himalaya_pink_salt_intensive_whitening_spearmint_120g_tubehimalaya_pink_salt_intensive_whitening_spearmint_120g_tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN1
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD1
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY1

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43136-59143136-591-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
POTASSIUM PHOSPHATE, TRIBASIC16D59922JUIACT
GLYCERINPDC6A3C0OXIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XYLITOLVCQ006KQ1EIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
SODIUM ALGINATEC269C4G2ZQIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
ZINC STEARATEH92E6QA4FVIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM POLYMETAPHOSPHATEP1BM4ZH95LIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARRAGEENAN5C69YCD2YJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
D&C RED NO. 339DBA0SBB0LIACT
MONOPOTASSIUM PHOSPHITE59RSS63D8JIACT
XANTHAN GUMTTV12P4NEEIACT
SUCRALOSE96K6UQ3ZD4IACT
POLOXAMER 407TUF2IVW3M2IACT

Source Document#

Source XML

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
HIMALAYA PINK SALT Intensive Whitening SpearmintSODIUM FLUORIDETai Guk Pharma. Co., Ltd.14eb9f74-e5f5-e199-e063-6394a90adbf62024-03-29WarningsExact identifier
ndc (package): 43136-591-20
ndc (product): 43136-591
ndc11 (package): 43136059120
spl id: 14eb9f74-e5f6-e199-e063-6394a90adbf6
spl set id: 14eb9f74-e5f5-e199-e063-6394a90adbf6

Reported adverse events (FAERS/openFDA)#

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