Dibucaine

Product NDC
69396-023
11-digit product format
693960023
Labeler code
69396
Product ID
69396-023_0df7b6dd-a4d8-c9a6-e063-6394a90a0f52
Type
HUMAN OTC DRUG
Nonproprietary name
Dibucaine 1%
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-14
Substance
DIBUCAINE
Active strength
1 g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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
Dibucaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIBUCAINE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L6JW2TJG99Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238784Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e8a56651-a292-7609-e053-2a95a90a7c36Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-023-01Dibucaine28.4 g in 1 TUBEOINTMENT28.42
69396-023-01Dibucaine1 in 1 BOXOINTMENT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-023DIBUCAINE (DIBUCAINE 1%) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]2Current NDC, Legacy NDC, 2 package rows20240103_e8a56651-a292-7609-e053-2a95a90a7c36.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 117 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MYCO Clinic Pain ReliefMENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions604a30c9-2306-47a1-bd31-94b63639dd902024-11-20WarningsExact identifier
application number: M017
MYCO Clinic Pain ReliefCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions0b489420-3b5c-43c5-aab4-0e3720acf9ce2024-11-20WarningsExact identifier
application number: M017
MYCO Clinic Pain ReliefCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsdd906129-a787-4352-856d-d7a915031a6e2024-11-20WarningsExact identifier
application number: M017
Walgreens Arthritis Pain Relief CreamHISTAMINE DIHYDROCHLORIDEWalgreens Company80d3031a-7fa9-4f5b-b85e-c7c6ef3148012024-11-20WarningsExact identifier
application number: M017
Anti-Itch Medicated Maximum StrengthBENZOCAINE AND RESORCINOLWalgreens Company7fd86dcb-edef-4d0d-b389-7ecea595fe672024-11-20WarningsExact identifier
application number: M017
Walgreens Pain ReliefBENZOCAINEWalgreens Company7cee7234-32cd-4bf3-8a6c-0882585eec7f2024-11-20WarningsExact identifier
application number: M017
Walgreens Advanced Scar GelADVANCED SCAR GELWalgreens Company2c040475-a124-485c-933e-66b452f5ab462024-11-20WarningsExact identifier
application number: M017
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEClinic Pharma274611ea-7fc2-ba3f-e063-6294a90aa50f2024-11-19WarningsExact identifier
application number: M017
First Aid Only Sting Relief PadBENZOCAINEAcme United Corporation5087cbbd-1bbe-62ed-e054-00144ff8d46c2024-11-19WarningsExact identifier
application number: M017
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLAcme United Corporation6bb9a782-2394-4c8c-e053-2991aa0a08d42024-11-19WarningsExact identifier
application number: M017
First Aid Only Sting ReliefBENZOCAINEAcme United Corporation697127d1-c02e-16d2-e053-2a91aa0a39fd2024-11-19WarningsExact identifier
application number: M017
First Aid Only Hydrocortisone 1% Anti-ItchHYDROCORTISONEAcme United Corporatione5597b11-b08e-99e1-e053-2a95a90a15a52024-11-19WarningsExact identifier
application number: M017
Equate Cold Therapy Pain Relieving Roll-on AnalgesicMENTHOL, UNSPECIFIED FORMWal-Mart Stores, Inc.4115f0ac-e12a-4e59-94f5-a47dcc7f87662024-11-18WarningsExact identifier
application number: M017
Equate Cold Therapy Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORMWal-Mart Stores, Inc.ac6c2112-8692-4628-97d8-3a5a9f5097662024-11-18WarningsExact identifier
application number: M017
Equate Odor-Free Therapy Arthritis AnalgesicTROLAMINE SALICYLATEWal-Mart Stores, Inc.1d73e7b6-c7f9-4680-b3e3-a954b91e18632024-11-18WarningsExact identifier
application number: M017
First Aid Only BurnLIDOCAINE HYDROCHLORIDEAcme United Corporation9af39fcd-0a57-26d0-e053-2a95a90a99a02024-11-17WarningsExact identifier
application number: M017
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEAcme United Corporationcaa67a05-bdbd-c380-e053-2995a90a0bf12024-11-17WarningsExact identifier
application number: M017
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafewayc6b9c4e1-bab8-490d-8c00-c43377ad08572024-11-15WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEWalgreen Company1a9b8b4c-3e15-49e6-af91-76ed0dc0829e2024-11-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238784dibucaine 1 % Rectal OintmentPSNe8a56651-a292-7609-e053-2a95a90a7c362
238784dibucaine 0.01 MG/MG Rectal OintmentSCDe8a56651-a292-7609-e053-2a95a90a7c362
238784dibucaine 1 % Rectal OintmentSYe8a56651-a292-7609-e053-2a95a90a7c362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-023-01693960023011 TUBE in 1 BOX (69396-023-01) / 28.4 g in 1 TUBE1 tube2022-09-140000-00-00NoNoCurrent