FDA.reportPublic FDA data

ATOMY PROPOLIS TOOTHPAS TE 50G

Product NDC
52257-1380
Requested package NDC
52257-1380-2
11-digit product format
522571380
Labeler code
52257
Product ID
52257-1380_bf9632ba-2fdb-4d32-b069-b2533e94f974
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate, Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
ATOMY CO., LTD.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-01
Substance
SODIUM MONOFLUOROPHOSPHATE; SODIUM FLUORIDE
Active strength
.08; .05 g/50g; g/50g
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
ATOMY PROPOLIS TOOTHPAS TE 50G
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.08 g/50g
SODIUM FLUORIDE.05 g/50g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046867Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
98d839e3-a1aa-c83d-e053-2995a90a7e79Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52257-1380-1ATOMY PROPOLIS TOOTHPAS TE 50G50 g in 1 TUBEPASTE, DENTIFRICE505
52257-1380-2ATOMY PROPOLIS TOOTHPAS TE 50G4 in 1 CARTONPASTE, DENTIFRICE45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52257-1380ATOMY PROPOLIS TOOTHPAS TE 50G (SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [ATOMY CO., LTD.]5Current NDC, Legacy NDC, 2 package rows20240130_98d839e3-a1aa-c83d-e053-2995a90a7e79.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 25 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro Health Advanced Enamel RestoreSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd813f5f0-3135-4a8f-e053-2a95a90a55622026-01-08WarningsExact identifier
application number: M021
Crest 3D White BrillianceSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8e189fbd-5094-4398-b96c-8f95d89b9cdd2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Densify RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd84fb9f9-f2bc-358a-e053-2995a90abf072026-01-08WarningsExact identifier
application number: M021
Kids Crest Strawberry RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyeb7a5698-754c-4e46-e053-2a95a90a57b42026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Daily Cleansing and Whitening SystemSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company89a6fb36-5109-47f1-95ad-9381471ceeef2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced w/Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company2c1c5563-0b7e-4c7c-b49f-3d72e078cd282026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Fresh MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc81ba39d-c7ea-b2a5-e053-2995a90a0fe72026-01-08Exact identifier
application number: M021
Crest Premium Plus Breath Bacteria BlastSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc3f1d477-6dd8-0ac4-e053-2a95a90a37422026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Active Foam Whitening scopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc72b15e0-e69c-65fc-e053-2a95a90a54c82026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Scope Outlast UltraSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc3f63455-b09e-9877-e053-2a95a90a18442026-01-08WarningsExact identifier
application number: M021
Crest Tartar Protection Fresh Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company3d81d605-4f9b-3bb5-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M021
Crest Complete plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companye3b1f139-4fe8-f005-e053-2995a90a53b42026-01-08WarningsExact identifier
application number: M021
Crest 3D White Radiant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf3dd7a34-a0d8-4ac6-bbd1-7c3b86187a572026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Active Fresh plus Whitening ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc599d33f-788f-7fdd-e053-2a95a90a5f572026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi Benefit Whitening plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company66c41b24-d394-6609-e053-2a91aa0a0a2c2026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus 3 in 1SODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb6fab2eb-da5c-749f-e053-2995a90a13572026-01-08WarningsExact identifier
application number: M021
Crest Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company85477763-1db5-482f-90e5-e71f5c1b47652026-01-08WarningsExact identifier
application number: M021
Crest Fresh and WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf9b31f6b-6b3f-abe0-e053-6294a90acb252026-01-08WarningsExact identifier
application number: M021
Crest Complete plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc367c2cc-5e0f-bc4e-e053-2995a90a2e2c2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Glamorous WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc3f29f95-81b9-3989-e053-2a95a90af3a62026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046867sodium monofluorophosphate 0.16 % / sodium fluoride 0.1 % ToothpastePSN98d839e3-a1aa-c83d-e053-2995a90a7e795
1046867sodium fluoride 0.001 MG/MG / sodium monofluorophosphate 0.0016 MG/MG ToothpasteSCD98d839e3-a1aa-c83d-e053-2995a90a7e795
1046867sodium fluoride 0.1 % / sodium monofluorophosphate 0.16 % ToothpasteSY98d839e3-a1aa-c83d-e053-2995a90a7e795

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52257-1380-2522571380024 TUBE in 1 CARTON (52257-1380-2) / 50 g in 1 TUBE (52257-1380-1) 4 tube2019-12-010000-00-00NoNoCurrent