FDA.reportPublic FDA data

POP Gel Whatzzup Watermelon

Product NDC
43136-522
Requested package NDC
43136-522-60
11-digit product format
431360522
Labeler code
43136
Product ID
43136-522_2aabf642-2917-a735-e063-6394a90a83b5
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
2023-09-18
Substance
SODIUM FLUORIDE
Active strength
1.3 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
POP Gel Whatzzup Watermelon
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.3 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
05b18bb6-9fbf-469b-e063-6294a90a4f2fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43136-522-60POP Gel Whatzzup Watermelon1 in 1 CARTONPASTE, DENTIFRICE12
43136-522-60POP Gel Whatzzup Watermelon160 g in 1 TUBEPASTE, DENTIFRICE1602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43136-522POP GEL WHATZZUP WATERMELON (SODIUM FLUORIDE) PASTE, DENTIFRICE [TAI GUK PHARM. CO., LTD.]2Current NDC, 2 package rows20250103_05b18bb6-9fbf-469b-e063-6294a90a4f2f.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 30 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MIPaste One PerioMIPASTE ONE PERIOGC America Inc.d656b72d-48f8-4425-e053-2995a90ab1f22025-12-19WarningsExact identifier
application number: M021
MIPaste One Kids Blue RaspberryMIPASTE ONE KIDS BLUE RASPBERRYGC America Inc.c07e1058-903b-fd47-e053-2995a90afdab2025-12-19WarningsExact identifier
application number: M021
MIPaste Plus StrawberryMIPASTE PLUS STRAWBERRYGC America Inc.d7235ad7-83d7-12e5-e053-2a95a90aaeaf2025-12-19WarningsExact identifier
application number: M021
MIPaste One Kids Cotton CandyMIPASTE ONE KIDS COTTON CANDYGC America Inc.c07d6b50-1d67-ea7f-e053-2a95a90afbe42025-12-19WarningsExact identifier
application number: M021
MIPaste One Kids Bubble GumMIPASTE ONE KIDS BUBBLE GUMGC America Inc.c07c7853-763b-4383-e053-2995a90ab7252025-12-19WarningsExact identifier
application number: M021
MIPaste OneMIPASTE ONEGC America Inc.d71f8e6e-7005-4b3e-e053-2995a90a67892025-12-19WarningsExact identifier
application number: M021
TheraBreath AM-PM Twin PackSODIUM FLUORIDEChurch & Dwight Co., Inc.4618e390-9039-a1d0-e063-6294a90ab2942025-12-16WarningsExact identifier
application number: M021
Parodontax Gum Strengthen and ProtectSTANNOUS FLUORIDEHaleon US Holdings LLC3bb40ceb-841b-4a25-e063-6294a90ab8972025-12-15WarningsExact identifier
application number: M021
Sensodyne Pronamel Kids Bubble MintSODIUM FLUORIDEHaleon US Holdings LLC41b1e626-e79b-d638-e063-6394a90a1f5b2025-12-15WarningsExact identifier
application number: M021
Simple Truth Kids FlourideSODIUM MONOFLUOROPHOSPHATEKroger Company82b9db89-d108-3f64-e053-2991aa0aee742025-12-15WarningsExact identifier
application number: M021
Natural Adult FluorideSODIUM MONOFLUOROPHOSPHATEKrogera71c537e-39d9-1c3b-e053-2a95a90ac3ec2025-12-15WarningsExact identifier
application number: M021
Therabreath Overnight Chamomile MintSODIUM FLUORIDEChurch & Dwight Co., Inc.cc0c533c-145e-4877-b421-1baf3a3a572e2025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188d28f9-a814-0f98-e063-6294a90a106b2025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b4cf935-38a6-f4fb-e063-6394a90a4bc02025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188cddb2-c799-0897-e063-6294a90a5d962025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1ba491f4-2ad2-6e7b-e063-6394a90a9fb72025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188ac743-3ba8-4da4-e063-6294a90a8f872025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b682604-c563-01f1-e063-6294a90ab0bd2025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b110db1-fcc0-377f-e063-6394a90a4d442025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1b74ecc4-a1e6-348f-e063-6294a90a58942025-12-11Exact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN05b18bb6-9fbf-469b-e063-6294a90a4f2f2
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD05b18bb6-9fbf-469b-e063-6294a90a4f2f2
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY05b18bb6-9fbf-469b-e063-6294a90a4f2f2
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY05b18bb6-9fbf-469b-e063-6294a90a4f2f2
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY05b18bb6-9fbf-469b-e063-6294a90a4f2f2
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY05b18bb6-9fbf-469b-e063-6294a90a4f2f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43136-522-60431360522601 TUBE in 1 CARTON (43136-522-60) / 160 g in 1 TUBE1 tube2023-09-18NoNoCurrent