FDA.reportPublic FDA data

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 23 of 37 · 722 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBionpharma Inc.1790da99-2a22-e2a2-e063-6394a90ac36f2025-03-31WarningsExact identifier
application number: M015
HemAwayLIDOCAINEMelaleuca, Inc.cf842adf-fcd7-2c8c-e053-2995a90adea62025-03-27WarningsExact identifier
application number: M015
Petroleum JellyWHITE PETROLATUM JELLYWALGREENS1fc9eecd-fd25-827c-e063-6394a90a26a52025-03-26WarningsExact identifier
unii: B6E5W8RQJ4
Cocoa Butter Petroleum JellyWHITE PETROLATUM JELLYWALGREENS1fcc9626-6058-e9b3-e063-6394a90ab5252025-03-26WarningsExact identifier
unii: B6E5W8RQJ4
Numb and Number Anorectal CreamLIDOCAINEDermtech Labs, Inc31420635-5021-173d-e063-6294a90a407a2025-03-26WarningsExact identifier
application number: M015
Leader Maximum Strength Hemorrhoidal ReliefLIDOCAINECardinal Health,Inc.65c780b0-7f47-4ae9-a847-c22deaaa28882025-03-21WarningsExact identifier
application number: M015
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e572025-03-20WarningsExact identifier
unii: B6E5W8RQJ4
Gold Bond Diabetics Medicated Dry Skin Relief Foot CreamDIMETHICONE, WHITE PETROLATUMChattem, Inc.b951d1cb-b81e-4d7f-9a67-8405daa896672025-03-19WarningsExact identifier
unii: B6E5W8RQJ4
Leader Nighttime Relief Lubricant EyeLIGHT MINERAL OIL, WHITE PETROLATUMLEADER/Cardinal Health 110, Inc.308772fc-d6f6-da9f-e063-6394a90a41db2025-03-12WarningsExact identifier
unii: N6K5787QVP
unii: B6E5W8RQJ4
AD Skin ProtectantAD SKIN PROTECTANTWellSpring Pharmaceutical Corporationd26f1312-2e1b-4106-bc48-a336d4e034ad2025-03-07WarningsExact identifier
unii: 7EV65EAW6H
Curist Hemorrhoid Fissure ReliefLIDOCAINELittle Pharma, Inc2fb02b00-acdb-5184-e063-6294a90ae1c82025-03-06WarningsExact identifier
application number: M015
Thera Plus HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEFOURSTAR GROUP USA, INC.87143a7a-7b2d-4b67-afda-2355697e73002025-03-04WarningsExact identifier
application number: M015
Numbskin Maximum Strength Pain RelieverLIDOCAINEShinpharma Inc2f288bde-99fd-42f8-e063-6394a90a0f052025-02-27WarningsExact identifier
application number: M015
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
PREPARATION H TOTABLES IRRITATION RELIEF WIPESWITCH HAZELHaleon US Holdings LLC1953ec64-20ce-488b-8f14-44e15cc9e7202025-02-21WarningsExact identifier
application number: M015
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
LBRI STOP THE PAIN Super Aloe Pain Relief CreamMENTHOL, METHYL SALICYLATEL'BRI HEALTH AND BEAUTY INC62e18a37-c0db-4b1e-a6a1-35684cc00e082025-01-28WarningsExact identifier
application number: M015

Reported adverse events (FAERS/openFDA)#

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