FDA.reportPublic FDA data

EUTHYMOL Extraordinary Pink Whitening

Product NDC
43136-501
11-digit product format
431360501
Labeler code
43136
Product ID
43136-501_13907a4e-06cb-be14-e063-6394a90ab5c8
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Tai Guk Pharm. Co., Ltd.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-13
Substance
SODIUM FLUORIDE
Active strength
1.6 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
EUTHYMOL Extraordinary Pink Whitening
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.6 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
891775Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
13907bf6-9a95-c0b2-e063-6394a90a4042Available on FDA.report

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
43136-501-06EUTHYMOL Extraordinary Pink Whitening1 in 1 CARTONPASTE, DENTIFRICE12
43136-501-06EUTHYMOL Extraordinary Pink Whitening106 g in 1 TUBEPASTE, DENTIFRICE1062
43136-501-63EUTHYMOL Extraordinary Pink Whitening106 g in 1 TUBEPASTE, DENTIFRICE1061
43136-501-63EUTHYMOL Extraordinary Pink Whitening3 in 1 PACKAGEPASTE, DENTIFRICE31
43136-501-65EUTHYMOL Extraordinary Pink Whitening5 in 1 PACKAGEPASTE, DENTIFRICE51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43136-501EUTHYMOL EXTRAORDINARY PINK WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [TAI GUK PHARM. CO., LTD.]2Current NDC, 2 package rows20250103_05a9cee1-bd6e-6b93-e063-6294a90a5c10.zip
43136-501EUTHYMOL EXTRAORDINARY PINK WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [TAI GUK PHARM. CO., LTD.]1Current NDC, 3 package rows20240315_13907bf6-9a95-c0b2-e063-6394a90a4042.zip

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 9 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Restore and DefendSTANNOUS FLUORIDEWalgreense808ea4b-9081-085b-e053-2a95a90a4f9b2026-06-02WarningsExact identifier
application number: M021
Hello Unicorn Splash unicorn splash anticavity fluoride rinseSODIUM FLUORIDEColgate-Palmolive Companya1014431-7d23-aaff-6dc7-ab58683d03382026-06-02WarningsExact identifier
application number: M021
Therabreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.feab3d45-ff95-4b32-8258-7d932a7380c92026-06-01WarningsExact identifier
application number: M021
Orajel Toy Story 5 AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.4b80947d-f389-2f80-e063-6294a90abd552026-06-01WarningsExact identifier
application number: M021
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.54113245-0c1e-739e-e063-6294a90aea422026-06-01WarningsExact identifier
application number: M021
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.545258fd-8179-fffc-e063-6394a90a467f2026-06-01WarningsExact identifier
application number: M021
Orajel Paw PatrolSODIUM FLUORIDEChurch & Dwight Co., Inc.99d87bea-3e99-5d04-e053-2a95a90aaf542026-06-01WarningsExact identifier
application number: M021
Orajel SuperMarioANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.27d2f6cb-8661-da9c-e063-6394a90a5bde2026-06-01WarningsExact identifier
application number: M021
Orajel KidsToothpasteSODIUM FLUORIDEChurch & Dwight Co., Inc.99d62125-c2c5-5926-e053-2995a90aaa292026-06-01WarningsExact identifier
application number: M021
AIM CAVITY PROTECTION Multi BenefitSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0f8a33-0b01-40e2-e054-00144ff88e882026-06-01WarningsExact identifier
application number: M021
Crest plus Tartar Protection WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company560980ea-749f-593d-e063-6394a90a1b9e2026-06-01WarningsExact identifier
application number: M021
Colgate Revitalizing WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyc67223ae-b068-41c5-a15b-7ae9840b93ef2026-05-27WarningsExact identifier
application number: M021
Colgate Kids Harry PotterSODIUM FLUORIDEColgate-Palmolive Company61c06da4-9f02-4fbc-b80f-1c443e2984962026-05-26WarningsExact identifier
application number: M021
sodium fluoride rinseSODIUM FLUORIDE RINSERockland Cosmetics, Inc.52430b12-4d5f-d1e1-e063-6394a90abd642026-05-20Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEH E Bd0a52519-3339-40ea-93e5-78f76d348a4d2026-05-14Warnings, Adverse reactionsExact identifier
application number: M021
Burts Bees Extra WhiteSODIUM FLUORIDEProcter & Gamble Manufacturing Companyc92524fd-8b93-592d-e053-2a95a90a88c62026-05-13WarningsExact identifier
application number: M021
MIPaste Plus StrawberrySODIUM FLUORIDEGC America Inc.1b68bd67-65d3-4c64-e054-00144ff8d46c2026-05-12WarningsExact identifier
application number: M021
White Glo Purple Color Corrector Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc6f8b77c3-9833-4c75-b41c-a2bc126161572026-05-12WarningsExact identifier
application number: M021
botalab HERBAL COMPLETE TOOTHSODIUM FLUORIDEKMPHARMACEUTICAL CO., LTD.51365ef7-ed94-2650-e063-6394a90ab89e2026-05-07WarningsExact identifier
application number: M021
Morning Fresh Mint Toothpaste, with FluorideMORNING FRESH MINT TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a42d8ce-e7f2-caa5-e063-6294a90ac01f2026-05-07WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN05a9cee1-bd6e-6b93-e063-6294a90a5c102
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD05a9cee1-bd6e-6b93-e063-6294a90a5c102
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY05a9cee1-bd6e-6b93-e063-6294a90a5c102
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY05a9cee1-bd6e-6b93-e063-6294a90a5c102
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY05a9cee1-bd6e-6b93-e063-6294a90a5c102
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY05a9cee1-bd6e-6b93-e063-6294a90a5c102
891775sodium fluoride 0.243 % ToothpastePSN13907bf6-9a95-c0b2-e063-6394a90a40421
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD13907bf6-9a95-c0b2-e063-6394a90a40421
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY13907bf6-9a95-c0b2-e063-6394a90a40421
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY13907bf6-9a95-c0b2-e063-6394a90a40421
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY13907bf6-9a95-c0b2-e063-6394a90a40421
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY13907bf6-9a95-c0b2-e063-6394a90a40421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43136-501-06431360501061 TUBE in 1 CARTON (43136-501-06) / 106 g in 1 TUBE1 tube2023-09-18NoNoCurrent
43136-501-6343136050163106 g in 1 TUBE106 gHistorical
43136-501-65431360501655 PACKAGE in 1 PACKAGE (43136-501-65) / 3 TUBE in 1 PACKAGE (43136-501-63) / 106 g in 1 TUBE5 package2024-03-13NoNoCurrent