FDA.reportPublic FDA data

SEACALL Mouthwash

Product NDC
76986-005
11-digit product format
769860005
Labeler code
76986
Product ID
76986-005_2c1a7eed-6a7d-eeb2-e063-6394a90aafcc
Type
HUMAN OTC DRUG
Nonproprietary name
Mouthwash
Dosage form
LIQUID
Route
ORAL
Labeler
Guangdong Quadrant Ecological Technology Co., Ltd.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-20
Substance
METRONIDAZOLE; CHLORHEXIDINE DIGLUCONATE
Active strength
.2; .6 g/100mL; g/100mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
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
SEACALL Mouthwash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE.2 g/100mL
CHLORHEXIDINE DIGLUCONATE.6 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
140QMO216EInternal UNII lookup
MOR84MUD8EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2702642Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2c1a7eed-6a7c-eeb2-e063-6394a90aafccAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55Product name520251024
7f6d14e0-4366-41bc-a4a9-b74c79a20e17Product name120250623
e6d321b0-0e5e-7da6-f043-92b6a91f00a1Product name520250515
e1aac33b-94ae-4ee9-905b-299f7263853bProduct name320250124
16642716-d28a-4f90-8dcb-3921cd8c8109Product name420240516
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
a5070875-62bb-61e1-fd46-8f7054197a40Product name820180215
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
0add4de9-d152-3375-3390-1123dddc5e3dProduct name120140508
33ca0fcc-1011-92dc-50a9-a383683eed1eProduct name120140508
53f39d9f-cd3f-04e1-c668-d4580719d57dProduct name120140508
a804000f-b74f-0b5d-d17b-aa767c286ddbProduct name120140508
a91ea265-6e02-c08f-93c8-686d54180529Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76986-005-01SEACALL Mouthwash100 mL in 1 BOTTLELIQUID1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76986-005SEACALL MOUTHWASH (MOUTHWASH) LIQUID [GUANGDONG QUADRANT ECOLOGICAL TECHNOLOGY CO., LTD.]1Current NDC, 1 package rows20250121_2c1a7eed-6a7c-eeb2-e063-6394a90aafcc.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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2702642chlorhexidine digluconate 0.6 % / metroNIDAZOLE 0.2 % MouthwashPSN2c1a7eed-6a7c-eeb2-e063-6394a90aafcc1
2702642chlorhexidine gluconate 6 MG/ML / metronidazole 2 MG/ML MouthwashSCD2c1a7eed-6a7c-eeb2-e063-6394a90aafcc1
2702642chlorhexidine digluconate 0.6 % / metronidazole 0.2 % MouthwashSY2c1a7eed-6a7c-eeb2-e063-6394a90aafcc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76986-005-0176986000501100 mL in 1 BOTTLE (76986-005-01) 100 ml2025-01-20NoNoCurrent