FDA.reportPublic FDA data

R B one

Product NDC
84540-140
11-digit product format
845400140
Labeler code
84540
Product ID
84540-140_463cf5ec-b495-d4e9-e063-6394a90a6602
Type
HUMAN OTC DRUG
Nonproprietary name
Phosphatidylserine, Zinc Oxide
Dosage form
TABLET
Route
ORAL
Labeler
NPG Bio Pharmaceuticals Co.,Ltd.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-01
Substance
ZINC OXIDE; PHOSPHATIDYL SERINE; GINKGO BILOBA LEAF
Active strength
6.38; 214; 75.02 mg/1100mg; mg/1100mg; mg/1100mg
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
R B one
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE6.38 mg/1100mg
PHOSPHATIDYL SERINE214 mg/1100mg
GINKGO BILOBA LEAF75.02 mg/1100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
394XK0IH40Internal UNII lookup
19FUJ2C58TInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
410c40fd-cf94-0301-e063-6294a90ae2deAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84540-140-01R B one1100 mg in 1 BLISTER PACKTABLET110010

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 11 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Kids Advanced Color ChangingSODIUM MONOFLUOROPHOSPHATEProcter & Gamble Manufactura, S de R.L. de C.V.fc86b98e-d556-4769-e053-6394a90afc6e2026-01-08WarningsExact identifier
application number: M022
Care One Maximum StrengthFLUORIDEAmerican Sales1b6618ea-6533-41d7-be2c-13bb9e108dc52026-01-08WarningsExact identifier
application number: M022
equate SensitivePOTASSIUM NITRATE, SODIUM FLUORIDEWal-Mart Stores Inc79899b59-3a16-6504-e053-2991aa0a895a2026-01-08WarningsExact identifier
application number: M022
Crest Kids Advanced Color ChangingSODIUM MONOFLUOROPHOSPHATEProcter & Gamble Manufactura, S de R.L. de C.V.451283d3-78b0-8361-e063-6294a90a1fd52026-01-08WarningsExact identifier
application number: M022
CVS Maximum StrengthBENZOCAINECVS Pharmacy8691d6b6-741e-47b2-8332-76742b34715f2026-01-08WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum GelBENZOCAINEPublix Super Markets INC16eb9d15-dba3-36e6-e063-6394a90ab8592026-01-08WarningsExact identifier
application number: M022
Toothache and Gum ReliefBENZOCAINE, MENTHOLCVS Pharmacy814ec7bf-f825-1095-e053-2a91aa0aee592026-01-08WarningsExact identifier
application number: M022
LemonGLYCERINSion Biotext Medical Ltddbd7ed86-1b92-4471-827a-89f3afa1b0dc2026-01-08WarningsExact identifier
application number: M022
Sootheez Organic Wild CherryPECTINBFY LLC47baa2a8-270c-fa07-e063-6394a90a97f62026-01-06WarningsExact identifier
application number: M022
Parodontax Gum Strengthen and ProtectCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC3bb378c8-14b2-aa13-e063-6294a90a4db32026-01-05WarningsExact identifier
application number: M022
MySweetSmile Toothpaste.MYSWEETSMILE TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd478baf87-9276-7288-e063-6294a90a9e8e2026-01-04WarningsExact identifier
application number: M022
MySweetSmile Mango Toothpaste.MYSWEETSMILE MANGO TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd478cbdeb-28e1-fa56-e063-6294a90af1242026-01-04WarningsExact identifier
application number: M022
Smile PaintSODIUM FLUORIDEJABBER JAW KIDS TOOTHPASTE LLCa7463b5c-53b2-4353-a5ea-800fbd7bd17d2026-01-02WarningsExact identifier
application number: M022
Dentek Canker CoverMENTHOLBershtel Enterprises2669183c-7a58-037e-e054-00144ff88e882025-12-31WarningsExact identifier
application number: M022
AutoBrush strawberrySODIUM FLUORIDELander Enterprises, LLC05929148-bffe-439f-a9d4-3170816c0fa22025-12-31WarningsExact identifier
application number: M022
AutoBrush WatermelonSODIUM FLUORIDELander Enterprises, LLC37a4e712-e3b5-42f6-971c-98dea4b8dd062025-12-31WarningsExact identifier
application number: M022
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLC6bcd35f5-18ea-4fc8-84cd-06db73f38a1e2025-12-31WarningsExact identifier
application number: M022
AutoBrush BubblegumSODIUM FLUORIDELander Enterprises, LLCe7bf7e31-650d-4a1c-9100-48722344b2012025-12-31WarningsExact identifier
application number: M022
Normal SaltSODIUM CHLORIDEGRAXCELL PHARMACEUTICAL, LLCf3f09817-8a38-4aa1-956b-69d9cf6950742025-12-25WarningsExact identifier
application number: M022
Sensitive Mint Tooth-pastePOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.1e5e8b24-8304-482c-ae80-73effcc345da2025-12-23WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84540-140-01845400140011100 mg in 1 BLISTER PACK (84540-140-01) 1100 mg2025-10-01NoNoCurrent