FDA.reportPublic FDA data

Dibucaine

Product NDC
71399-2829
11-digit product format
713992829
Labeler code
71399
Product ID
71399-2829_da90939a-75f0-4b82-94ff-8611fe746715
Type
HUMAN OTC DRUG
Nonproprietary name
Dibucaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Akron Pharma Inc.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-06
Substance
DIBUCAINE
Active strength
.28 g/28g
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
DIBUCAINE.28 g/28g

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
60469e43-ab6f-46d3-a1df-00e58275f565Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71399-2829-12023-02-28Dibucaine Ointment
71399-2829-22023-02-28Dibucaine Ointment
71399-2829-12023-01-30Dibucaine Ointment
71399-2829-22023-01-30Dibucaine Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-2829-1Dibucaine28 g in 1 TUBEOINTMENT286
71399-2829-2Dibucaine56 g in 1 TUBEOINTMENT566
71399-2829-2Dibucaine1 in 1 PACKAGEOINTMENT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-2829-1GM - Gram71399-28293f757800-4f65-4c65-be72-d7b496835bb612021-09-07
71399-2829-2GM - Gram71399-2829db3bb464-5bc6-4590-8d1c-c687e77a7b0612021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-2829DIBUCAINE OINTMENT [AKRON PHARMA INC.]6Current NDC, Legacy NDC, 3 package rows20250114_60469e43-ab6f-46d3-a1df-00e58275f565.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 6 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREPARATION H MEDICATED WIPESWITCH HAZELHaleon US Holdings LLC8d9961f0-1ecf-d7fb-b6b4-856d636d68e12026-03-17WarningsExact identifier
application number: M015
Crane Safety BurnLIDOCAINECrane Safety LLC96d81566-6321-731e-e053-2995a90ad07d2026-03-16WarningsExact identifier
application number: M015
Signature Lidocaine Pain Relief Cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD4c56b3b3-33b3-a50e-e063-6394a90a955f2026-03-06WarningsExact identifier
application number: M015
WowDay Medicated Hemorrhoidal Flushable WipesMEDICATED HEMORRHOIDAL FLUSHABLE WIPESWowDay LLC4c603b27-4835-bc40-e063-6394a90a8ea22026-03-06WarningsExact identifier
application number: M015
Numb Fast HemorrhoidalLIDOCAINEOasis Plus LLCa00ffed7-8034-4cc0-87c4-3c793c1bcd6e2026-03-03WarningsExact identifier
application number: M015
Curist Lidocaine ReliefLIDOCAINE 5%Little Pharma, Inc.f562b57d-6592-93fa-e053-2995a90ae3e02026-03-02WarningsExact identifier
application number: M015
Therapain PlusMENTHOL ROLL-ONEpic Laboratories, LLC0249cfdf-b7c4-f27d-e063-6294a90aaa262026-03-02WarningsExact identifier
application number: M015
Liposomal Hemorrhoid MasterLIDOCAINE , PHENYLEPHRINE HCLClinical Resolution Laboratory, Inc.a1e15d2a-44b6-4d9c-89c2-0ff12285724e2026-03-02WarningsExact identifier
application number: M015
Equate Hemorrhoid ReliefLIDOCAINEWalmart Inc.48646860-ed5d-62a0-e063-6394a90abb232026-03-01WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELThe Kroger Co.bbf2efd7-f181-403b-ac5f-695f7ba158752026-02-27Warnings, Adverse reactionsExact identifier
application number: M015
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
application number: M015
Megababe Fun Gal Stuff AntifungalCLOTRIMAZOLEMegababe LLCc599d27b-fdb0-465f-9e43-13d32c520a922026-02-25WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELBetter Living Brands, LLC0355edab-b6f7-4e59-bce1-cf6a8897b9892026-02-24Warnings, Adverse reactionsExact identifier
application number: M015
Zinc Oxide and MentholZINC OXIDE, MENTHOLAkron Formulations India Private Limited4b84556c-521f-eebd-e063-6394a90a8e1e2026-02-23WarningsExact identifier
application number: M015
CalprotectMENTHOL, ZINC OXIDEReliable 1 Laboratories LLC09fb2810-0cc1-b2e2-e063-6294a90a45762026-02-19WarningsExact identifier
application number: M015
OxifyLIDOCAINE 5%Weeks & Leo Compnay, INC.41d9d0b4-33e7-7e05-e063-6394a90a10112026-02-17WarningsExact identifier
application number: M015
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
application number: M015
Gniby - LIDOCAINE ANORECTAL HEMORRHOIDALNUMBINGPutian Licheng District Zhijiancheng Trading Co., Ltd.4a5f59f1-c11a-e2eb-e063-6394a90a3e272026-02-10WarningsExact identifier
application number: M015
Numb MasterLIDOCAINEClinical Resolution Laboratory, Inc.0921c824-a8a9-4707-a480-c750192983f52026-02-09WarningsExact identifier
application number: M015
Signature Care HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCIBetter Living Brands, LLC3c8b43f3-6e1e-499e-ba71-ffdf836f67432026-02-05WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238784dibucaine 1 % Rectal OintmentPSN60469e43-ab6f-46d3-a1df-00e58275f5656
238784dibucaine 0.01 MG/MG Rectal OintmentSCD60469e43-ab6f-46d3-a1df-00e58275f5656
238784dibucaine 1 % Rectal OintmentSY60469e43-ab6f-46d3-a1df-00e58275f5656

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-2829-17139928290128 g in 1 TUBE (71399-2829-1) 28 g2025-01-060000-00-00NoNoCurrent
71399-2829-2713992829021 TUBE in 1 PACKAGE (71399-2829-2) / 56 g in 1 TUBE1 tube2025-01-060000-00-00NoNoCurrent