FDA.reportPublic FDA data

Dentemp Canker Cover

Product NDC
73653-210
11-digit product format
736530210
Labeler code
73653
Product ID
73653-210_47e23f4e-d4a7-7af1-e063-6394a90a2f05
Type
HUMAN OTC DRUG
Nonproprietary name
Canker Cover
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL; TOPICAL
Labeler
DOC Brands
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-02
Substance
MENTHOL
Active strength
2.5 mg/1
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
Dentemp Canker Cover
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2628246Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2e7fbf9d-553c-c7bf-e063-6294a90a5f79Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73653-210-01Dentemp Canker Cover1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE12
73653-210-08Dentemp Canker Cover8 in 1 CARTONTABLET, EXTENDED RELEASE82

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 17 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WALMART SALINESALINE NASAL (SODIUM CHLORIDE)WALMART STORES INC06906744-49a5-4bab-8539-af2d235df9e82025-10-28WarningsExact identifier
application number: M022
SalineNASALPUBLIX SUPER MARKETS, INC19841567-9511-43d6-ba4e-d1e1bd3481a42025-10-28WarningsExact identifier
application number: M022
PUBLIX Sore Throat Fast Relief Oral AnestheticPHENOLPUBLIX SUPER MARKETS, INC89291f12-bbc3-4472-8ad3-a34485af72c92025-10-28WarningsExact identifier
application number: M022
PUBLIX Sore Throat Menthol FlavorPHENOLPUBLIX SUPER MARKETS, INC9296c49e-557c-43ed-9527-fcba5093a8dc2025-10-28WarningsExact identifier
application number: M022
WinCo Foods Maximum Strength Oral AnalgesicBENZOCAINEWinCo Foods, LLCc22a7726-8c3f-41bf-b852-8456b2be6f932025-10-28WarningsExact identifier
application number: M022
Rugby Cherry FlavorPHENOLRUGBY LABORATORIES3d668c78-8130-45d4-bcb7-dddcb2fbe7a32025-10-25WarningsExact identifier
application number: M022
LolliCaine Bubble GumBENZOCAINECentrix, Inc.56ae3a84-6bca-4906-a03d-9d755e1fba3b2025-10-24WarningsExact identifier
application number: M022
Diabetic Tussin Sore Throat CherryPHENOLMEDTECH PRODUCTS INCab351229-5771-4c6c-92a8-721cc41c002f2025-10-23WarningsExact identifier
application number: M022
Chloraseptic Total Sore Throat and Cough, Sugar FreeMENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEPrestige Brands Holdings, Inc.34e4234c-ed61-4795-99fe-d281cdb0af882025-10-23WarningsExact identifier
application number: M022
Chloraseptic Total Sore Throat and CoughMENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEPrestige Brands Holdings, Inc.6b1a50d0-be54-4fcb-b5e2-b47abf3555c02025-10-23WarningsExact identifier
application number: M022
Chloraseptic Childrens Sore Throat CherryPHENOLPrestige Brands Holdings, Inc.38ff6922-1abe-4fa9-a74e-ede604f707b52025-10-23WarningsExact identifier
application number: M022
Boka SensitivePOTASSIUM NITRATEKaraka LLC40be9fab-53db-c67a-e063-6394a90a48cb2025-10-23WarningsExact identifier
application number: M022
Canker Care PlusMENTHOL, UNSPECIFIED FORMQuantum, Inc.1ec960db-52d5-4d99-a7f7-a2e538d287242025-10-20WarningsExact identifier
application number: M022
meijer Sensitive EXTRA WHITENINGPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.bbcffb88-0bd4-4883-bb83-0b7a1428ad122025-10-20WarningsExact identifier
application number: M022
Quality Choice Maximum Strength Oral Pain RelievingBENZOCAINEChain Drug Marketing Association Incdbde8e7f-85d8-4083-b01a-3a7e410a77472025-10-17WarningsExact identifier
application number: M022
Quality ChoiceBENZOCAINEChain Drug Marketing Association, Inc.24c3c4a3-bd76-198d-e063-6394a90ad45a2025-10-16WarningsExact identifier
application number: M022
Sore Throat Relief Cherry FlavorPHENOLCardinal Healthb84203bd-23e9-427d-83d8-f4c88266e23c2025-10-14WarningsExact identifier
application number: M022
FinaftaBENZOCAINE, GLYCERINEfficient Laboratories Inc.03368603-3e11-c2fa-e063-6294a90a04ea2025-10-14WarningsExact identifier
application number: M022
Sensodyne Pronamel Clinical Enamel Strength Whitening ActionPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCe8a62f24-1db6-45fb-b6e1-5e57103f82bc2025-10-14WarningsExact identifier
application number: M022
evo SENSITIVE ANTI-CAVITY FLUORIDE SWEET MINTPOTASSIUM NITRATE, SODIUM FLUORIDEAshtel Studios, Inc.bc74d2a6-fe34-44cf-b015-70ed4d47c9332025-10-13WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2628246menthol 2.5 MG Buccal TabletPSN2e7fbf9d-553c-c7bf-e063-6294a90a5f792
2628246menthol 2.5 MG Buccal TabletSCD2e7fbf9d-553c-c7bf-e063-6294a90a5f792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73653-210-01736530210011 in 1 BLISTER PACKHistorical
73653-210-08736530210088 BLISTER PACK in 1 CARTON (73653-210-08) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (73653-210-01) 8 blister pack2023-02-02NoNoCurrent