FDA.reportPublic FDA data

Dental system starter kit

Product NDC
87649-0001
11-digit product format
876490001
Labeler code
87649
Product ID
87649-0001_55747c80-079a-f753-e063-6394a90aa296
Type
HUMAN OTC DRUG
Nonproprietary name
US convenience kit (718907)
Dosage form
KIT
Route
ORAL
Labeler
Dyson Technology Limited
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-10
NDC exclude flag
No
Listing certified through
2027-12-31
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
Dental system starter kit
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313029Internal RxNorm lookup
1038800Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5355b79b-711f-1a4a-e063-6394a90afc4bAvailable on FDA.report

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 20 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Mouth Sore ReliefBENZOCAINEWalgreens253d7ea2-e48e-c7d7-e063-6394a90ae0012025-08-12WarningsExact identifier
application number: M022
Charm Tex FLUORIDE GelSODIUM FLUORIDEYangzhou Hongshengding Chemical Co.,Ltd.897b0102-1c96-4699-908e-a7b7e26cd29f2025-08-08WarningsExact identifier
application number: M022
Meijer Enamel GuardPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer Distribution Inc82bc95be-0a07-3f00-e053-2a91aa0a74382025-08-08WarningsExact identifier
application number: M022
Topco Associates LLC Maximum StrengthFLUORIDETopco Associates LLCac398ff0-0010-4e13-8b89-dc986fd7f9742025-08-08WarningsExact identifier
application number: M022
QUALITY CHOICE SALINEPLUS SOOTHING ALOEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)4ae4e88a-aaa5-4195-bedc-622fd5cd93942025-07-30WarningsExact identifier
application number: M022
Aseptil RojoPHENOLMenper Distributors, Inc.62c96dc1-4698-43c1-8e6d-f4062dc5eea22025-07-22WarningsExact identifier
application number: M022
AnestenkaBENZOCAINEMenper Distributors, Inc00a3f1bc-ddfe-47c6-8221-f48f915135032025-07-22WarningsExact identifier
application number: M022
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
application number: M022
SprinJene Natural Sensitivity and GumPOTASSIUM NITRATEHealth and Natural Beauty USA Corp3cb23e36-0e8c-4172-b4ae-859b58a2739f2025-07-07WarningsExact identifier
application number: M022
Normal SaltSODIUM CHLORIDETwin Med LLCdc82ff0f-8600-373a-e053-2995a90a75052025-07-03WarningsExact identifier
application number: M022
Sensodyne Pronamel Kids Berry TwistSODIUM FLUORIDEHaleon US Holdings LLC69c07c36-b5e0-420b-ab29-7d10913863222025-07-03WarningsExact identifier
application number: M022
DenTek Instant Pain Relief Maximum StrengthBENZOCAINEDenTek Oral Care, Inc.ae92b76e-815a-4b4c-8128-bd045098caa52025-06-30WarningsExact identifier
application number: M022
Sensodyne Clinical White Stain ProtectorPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC99037e59-53d6-492c-8fce-67641fc8efdd2025-06-25WarningsExact identifier
application number: M022
Iolite-SBENZOCAINEDharma Research, Inc.b3b68914-2adc-4f07-9521-0b18756be5222025-06-14WarningsExact identifier
application number: M022
Red Cross ToothacheEUGENOLThe Mentholatum Company3537e599-65d9-48d6-8a46-d42312f71e842025-06-11WarningsExact identifier
application number: M022
QUALITY CHOICE Sore ThroatPHENOLCHAIN DRUG MARKETING ASSOCIATIONc95ee086-f384-475d-ad0c-75518cb9d2fe2025-06-10WarningsExact identifier
application number: M022
Onral Oral Pain Reliever MouthwashBENZOCAINESyka Pharma Inc.5dd8d933-6f32-4eaf-8eca-9365d7de55a22025-06-03WarningsExact identifier
application number: M022
Orajel Rescue Relief PenORAL PAIN RELIEVERChurch & Dwight Co., Inc.2d68eec5-ae8a-9cdf-e063-6294a90a97992025-06-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC9e1f7462-a052-4db4-bc59-cce437b695d02025-05-20WarningsExact identifier
application number: M022
Saline 1.5 FL OZSALINEALAINA HEALTHCARE PRIVATE LIMITEDf1bdbb25-6943-4828-9ae0-7d9783c18b5f2025-05-19WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87649-0001-1876490001011 BOTTLE in 1 BOX (87649-0001-1) / 1 TUBE in 1 BOTTLE / 1 KIT in 1 TUBE * 1 BOTTLE in 1 BOX / 400 mL in 1 BOTTLE * 1 TUBE in 1 BOX / 94.5 g in 1 TUBE1 bottle2026-06-10NoNoCurrent