FDA.reportPublic FDA data

Foamgle Foam Mouthwash Super Mint

Product NDC
50555-210
Requested package NDC
50555-210-02
11-digit product format
505550210
Labeler code
50555
Product ID
50555-210_352342bf-e2de-3a2c-e063-6294a90a200e
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin
Dosage form
LIQUID
Route
ORAL
Labeler
KMPHARMACEUTICAL CO.,LTD
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-05-01
Substance
ALLANTOIN
Active strength
.05 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Foamgle Foam Mouthwash Super Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN.05 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
344S277G0ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
352342bf-e2dd-3a2c-e063-6294a90a200eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50555-210-01Foamgle Foam Mouthwash Super Mint50 mL in 1 BOTTLELIQUID501
50555-210-02Foamgle Foam Mouthwash Super Mint1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50555-210FOAMGLE FOAM MOUTHWASH SUPER MINT (ALLANTOIN) LIQUID [KMPHARMACEUTICAL CO.,LTD]1Current NDC, 2 package rows20250516_352342bf-e2dd-3a2c-e063-6294a90a200e.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foamgle Foam Mouthwash Super MintALLANTOINKMPHARMACEUTICAL CO.,LTD352342bf-e2dd-3a2c-e063-6294a90a200e2025-05-14WarningsExact identifier
ndc (package): 50555-210-02
ndc (product): 50555-210
ndc11 (package): 50555021002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50555-210-02505550210021 BOTTLE in 1 CARTON (50555-210-02) / 50 mL in 1 BOTTLE (50555-210-01) 1 bottle2025-05-01NoNoCurrent