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 13 of 37 · 722 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOLD LABEL B NUMBLIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDESCALP TECH INC1211590a-13b5-2e75-e063-6394a90a0f862026-01-09WarningsExact identifier
application number: M015
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEUniversal Distribution Center LLC90844919-f16a-4390-9dca-b0405b5014452026-01-08WarningsExact identifier
application number: M015
Signature numbing cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD47dda425-86d8-441e-e063-6294a90a0f9a2026-01-08WarningsExact identifier
application number: M015
AER Traveler ToweletteAER TRAVELERBirchwood Laboratories LLC26556b9b-1c3a-6cf5-e063-6394a90ab26c2026-01-08WarningsExact identifier
application number: M015
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC49a93cfc-4ccd-4ef3-928f-901b9926f7942026-01-08WarningsExact identifier
application number: M015
PREPARATION H FOR WOMENWITCH HAZELHaleon US Holdings LLCa9099cf4-4e2e-4cf1-a52f-48f8e174cb152026-01-08WarningsExact identifier
application number: M015
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
LIPOCAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.849d6e28-a6b8-7f49-e053-2a91aa0a497d2026-01-08WarningsExact identifier
application number: M015
TOPICAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.15d33ff7-34ed-253d-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M015
Dr Wellskin Numbing Cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD47ebedc5-caf1-a774-e063-6394a90ae14d2026-01-08WarningsExact identifier
application number: M015
Dr. Care Numbing CreamLIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD47c94198-7718-bbc2-e063-6294a90a48f12026-01-07WarningsExact identifier
application number: M015
Healthwise Anorectal Pain ReliefLIDOCAINE 5%Veridian Healthcare19c24e1b-a31b-478b-a48b-c39bb4753ca72026-01-06WarningsExact identifier
application number: M015
Good Sense Hemorrhoidal Maximum Strength Pain ReliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUML. Perrigo Company1d6142b6-3746-46f1-99ec-4b19d26f056e2026-01-06WarningsExact identifier
application number: M015
Sting Relief prep PadSTING RELIEF PREP PADSHENZHEN BENLIJU BIO-TECH CO.,LTD202c7b77-1a48-52a5-e063-6394a90a2eb22026-01-05WarningsExact identifier
unii: 7EV65EAW6H
CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger CotsLIDOCAINECVS PHARMACY, INCcaef51a8-76e9-42b3-a160-c54f62b47de12026-01-05WarningsExact identifier
application number: M015
Skin Protectant for Babies and kidsSKIN PROTECTANT OINTMENTNeilmed Pharmaceuticals Inc.448b70db-ca81-db7b-e063-6294a90a5f0d2026-01-02WarningsExact identifier
unii: 7EV65EAW6H
CVS Maximum OTC Strength Hemorrhoidal with AloeGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY,INCb55c63fb-5dfa-4567-8192-58f4038688372026-01-02WarningsExact identifier
application number: M015
unii: B6E5W8RQJ4
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
HemRid Anorectal CreamLIDOCAINEKKA & Associates LLCdbeb4325-3e85-1147-e053-2995a90a21602025-12-31WarningsExact identifier
application number: M015

Reported adverse events (FAERS/openFDA)#

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