NDC 71399-2829-01 - Dibucaine

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
71399-2829
Requested NDC
71399-2829-01
Package NDCs from labels
71399-2829-1, 71399-2829-2, 71399-2829-01
Manufacturer
Akron Pharma Inc.
Effective date
2025-01-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dibucaine OintmentAkron Pharma Inc.2025-01-12HUMAN OTC DRUG LABEL

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 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

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

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 16 of 37 · 722 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Launch MedicalLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC293ef514-44c1-43ac-9a81-c30e34ad39e52025-11-12WarningsExact identifier
application number: M015
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
application number: M015
Hazel Perineal Healing FoamWITCH HAZELJiangsu Senwo Medical Technology Co., Ltd.314b75cb-affe-a248-e063-6294a90a47b72025-11-07WarningsExact identifier
application number: M015
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLPranicura Products LLCaf520a58-3f3c-4d28-a41f-3ed8f74da0952025-11-04WarningsExact identifier
application number: M015
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MedlinePETROLATUMMedline Industries, LPf3062b61-e4c4-9f57-e053-2995a90aa0282025-11-04WarningsExact identifier
unii: B6E5W8RQJ4
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ProCure ClamaPlexZINC OXIDE 20.625, MENTHOL 0.44, WHITE PETROLATUM 66.335Twin Med LLC3d366857-5178-9032-e063-6294a90a40f32025-11-01WarningsExact identifier
application number: M015
unii: B6E5W8RQJ4
Diaper Rash skin protectantLANOLIN AND PETROLATUMUniversal Distribution Centre LLC1852246a-6a1c-49ab-e063-6294a90a90482025-10-30WarningsExact identifier
unii: 7EV65EAW6H
GNP HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE, HCLAmerisource Bergenb0f0ef97-9add-717f-e053-2a95a90a0eb02025-10-30WarningsExact identifier
application number: M015
REMEDY Calazime Skin ProtectantCALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP1295cfcc-5b61-481b-964b-f53ffd0cb58e2025-10-30WarningsExact identifier
application number: M015
Hemorrhoid AnestheticMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUniversal Distribution Center LLC186c2d32-e8c5-d13d-e063-6294a90a2b0e2025-10-30WarningsExact identifier
application number: M015
WorkvieLIDOCAINE HCL, MENTHOLMarketites LLCaebaffb5-58dd-ebd5-e053-2a95a90a14ed2025-10-29WarningsExact identifier
application number: M015
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMPublix Super Markets Inc354a640c-bc7e-45c8-9df0-8b5b01767f5c2025-10-29WarningsExact identifier
application number: M015
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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