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 13 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GoodSense Hemorrhoidal Pain ReliefGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPerrigo Direct, Inc2e5f699d-45e8-6451-e063-6394a90a8ad82025-07-20WarningsExact identifier
application number: M015
Good Sense HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLL. Perrigo Company379f8738-a871-4b09-abd1-c86386dfee042025-07-15WarningsExact identifier
application number: M015
Maximum Strength Hemorrhoidal PadsWITCH HAZELWalmart, Inc.6dd8d3d9-5109-4869-917b-9521e9ba1ed02025-07-14WarningsExact identifier
application number: M015
Nikzon HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDEGenomma Lab USA8f9a9939-2c99-489f-b597-9a51ec2684f92025-07-14WarningsExact identifier
application number: M015
ReVIVOL-XRPHENYLEPHRINE HYDROCHLORIDEUnipack LLC2950fe83-a2a4-4ed4-b645-69d6fd2381ae2025-07-13WarningsExact identifier
application number: M015
medicated wipesWITCH HAZELMeijer Distribution Inc.ba0f3f9a-95d1-4d8a-86d1-2c25c945118c2025-07-11WarningsExact identifier
application number: M015
hemorrhoidal padsWITCH HAZELMeijer Distribution Inc.53e39d22-a89e-4f95-8c64-abeb50f72ce72025-07-11WarningsExact identifier
application number: M015
INVIGOR OHLIDOCAINENatureplex LLC7c7b536d-e41a-4017-9df9-982e2e9cfe4e2025-07-10WarningsExact identifier
application number: M015
Maximum Strength Hemorrhoidal Cream with AloeGLYCERIN, PHENYLEPHINE HCI, PRAMOXINE HCI, PETROLATUMChain Drug Marketing Association396ea654-8be1-591a-e063-6294a90a11e22025-07-08WarningsExact identifier
application number: M015
PREPARATION H SOOTHING RELIEF ANTI-ITCHHYDROCORTISONEHaleon US Holdings LLCd6148d77-ef6f-4552-b5ba-43b429923f192025-07-07WarningsExact identifier
application number: M015
Rectal Care CreamRECTAL CARE CREAMAllegiant Healthce585082-ad39-4b6f-a756-0d9a81a13eb82025-07-07WarningsExact identifier
application number: M015
Bisacodyl LaxativeBISACODYL LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cb0386-a662-6893-e063-6294a90aa71a2025-07-03WarningsExact identifier
application number: M015
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc38cf4e43-280b-eb96-e063-6294a90a59492025-07-02WarningsExact identifier
application number: M015
TN Dickinsons Medicated Cooling Foam Hemorrhoidal ReliefWITCH HAZELDickinson Brands Inc.deca8ae2-53a3-4c90-aa10-45354e2cdab82025-06-27WarningsExact identifier
application number: M015
Glycerin LaxativeGLYCERIN LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cc266a-196f-16ce-e063-6394a90a24af2025-06-20WarningsExact identifier
application number: M015
Phenylephrine HemorrhoidalHEMORRHOIDAL SUPPOSITORIESNeilmed Pharmaceuticals Inc.35ccb320-e902-3d1a-e063-6294a90a68d52025-06-20WarningsExact identifier
application number: M015
ProCure HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTwin Med LLC37a4cc43-0d53-f1bf-e063-6394a90a2dc92025-06-15WarningsExact identifier
application number: M015
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF OINTMENTNeilmed Pharmaceuticals Inc.374d89b6-9305-9adf-e063-6394a90adb322025-06-11WarningsExact identifier
application number: M015
Dermoplast Post PartumBENZOCAINEAdvantice Health, LLC374dced3-6527-b458-e063-6394a90a911e2025-06-11WarningsExact identifier
application number: M015
foster and thrive hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLStrategic Sourcing Services LLCfb3bc359-b06b-4995-aa68-0117a639dff22025-06-11WarningsExact 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