FDA.reportPublic FDA data

NDC 60630-077-01 - Dentek Instant Pain Relief Maximum Strength

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
60630-077
Requested NDC
60630-077-01
Package NDCs from labels
60630-077-03, 60630-077-04, 60630-077-01, 60630-077-02
Manufacturer
IIMED MEDICAL MEXICANA S. DE R.L. DE C.V
Effective date
2023-10-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Benzocaine - IIMED MEDICAL MEXICANA S. DE R.L. DE C.VIIMED MEDICAL MEXICANA S. DE R.L. DE C.V2023-10-05HUMAN OTC DRUG LABEL
DenTek Instant Pain Relief Maximum Strength - Team Technologies, IncTeam Technologies, Inc2022-10-13HUMAN OTC DRUG LABEL
DENTEK INSTANT PAIN RELIEFDenTek Oral Care, Inc.2021-10-18HUMAN OTC DRUG LABEL
DenTek Instant Pain ReliefDenTek Oral Care. Inc. | DenTek Oral Care, Inc.2013-11-04HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60630-077-042025-01-30C16284748780-12cef2736-60a3-d83d-e063-dadaa90ab31fDENTEK INSTANT PAIN RELIEF
60630-077-022023-12-05C16284748780-19855e2a2-45c9-60a7-e053-dbdaa90a05bdDenTek Instant Pain Relief
60630-077-022019-11-27C16284748780-19855e2a2-45c9-60a7-e053-dbdaa90a05bdDenTek Instant Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60630-077-03DenTek Instant Pain ReliefMaximum Strength3.5 mL in 1 VIAL, GLASSLIQUID3.56
60630-077-04DenTek Instant Pain ReliefMaximum Strength1 in 1 CARTONLIQUID16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60630-077DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH (BENZOCAINE) LIQUID [DENTEK ORAL CARE, INC.]6Legacy NDC, 2 package rows20211014_3a3468b4-0625-71cd-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH (BENZOCAINE) LIQUID [DENTEK ORAL CARE. INC.]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH (BENZOCAINE) LIQUID [DENTEK ORAL CARE. INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQDENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH (BENZOCAINE) LIQUID [DENTEK ORAL CARE. INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH (BENZOCAINE) LIQUID [DENTEK ORAL CARE. INC.]1

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 4 of 35 · 698 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Pharmacy Maximum StrengthBENZOCAINECVS Pharmacy92747826-cf58-4406-b3b5-12f7c7077c2c2026-04-20WarningsExact identifier
unii: U3RSY48JW5
BenzodentBENZOCAINEFocus Consumer Healthcare, LLC5fdcb871-d387-6352-e053-2991aa0a09da2026-04-20WarningsExact identifier
unii: U3RSY48JW5
Sting Relief SwabBENZOCAINE4 Visions LLC4fc7a356-2f1d-85af-e063-6394a90aec6b2026-04-18WarningsExact identifier
unii: U3RSY48JW5
Coleman Bite and Sting ReliefEXTERNAL ANESTHETIC AND FIRST AID ANTISEPTICWisconsin Pharmacal Company4fadf1f1-478a-5104-e063-6294a90a10cb2026-04-17WarningsExact identifier
unii: U3RSY48JW5
Coleman Sting and Bite ReliefEXTERNAL ANALGESIC AND FIRST AID ANTISEPTICWisconsin Pharmacal Company4f94ab35-3099-716c-e063-6294a90a8bea2026-04-16WarningsExact identifier
unii: U3RSY48JW5
BiteMDINSECT BITE RELIEFWisconsin Pharmacal Company4f860c1e-a638-4923-e063-6294a90ae7e22026-04-15WarningsExact identifier
unii: U3RSY48JW5
Sting Relief SwabBENZOCAINE4 Visions LLC4f76a8c5-fde6-eee0-e063-6394a90a09f82026-04-14WarningsExact identifier
unii: U3RSY48JW5
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
unii: B697894SGQ
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.5eb437c5-a2af-4c0d-b7b9-9ab7d093db852026-04-06WarningsExact identifier
unii: U3RSY48JW5
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.c3fb6705-c647-4fe6-9aca-29735d01d8ea2026-04-02WarningsExact identifier
unii: U3RSY48JW5
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: B697894SGQ
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: B697894SGQ
Benzocaine 20%BENZOCAINE 20%PAI Holdings, LLC dba PAI Pharma7fbce9a5-00dc-4a4a-8709-ab752bdf2f592026-03-25WarningsExact identifier
rxcui: 308657
unii: U3RSY48JW5
BLINK TRIPLE CAREPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporateda2b34eb0-001b-4f42-a8cc-c2a0150fafcc2026-03-20WarningsExact identifier
unii: B697894SGQ
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f91e609-8ca5-0492-e053-2a95a90a85d02026-03-17WarningsExact identifier
unii: U3RSY48JW5
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f81ffa5-05fd-4eef-e053-2995a90aac3e2026-03-17WarningsExact identifier
unii: U3RSY48JW5
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f947366-9380-3fa9-e053-2a95a90ad49c2026-03-17WarningsExact identifier
unii: U3RSY48JW5
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f947672-4873-5546-e053-2a95a90a3c4b2026-03-17WarningsExact identifier
unii: U3RSY48JW5
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f9490c1-8bfe-3166-e053-2a95a90a71752026-03-17WarningsExact identifier
unii: U3RSY48JW5
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f94b65d-47e3-9c6b-e053-2a95a90aa1f82026-03-17WarningsExact identifier
unii: U3RSY48JW5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.