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 29 of 36 · 714 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
hemorrhoidal maximum strength pain reliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMKroger Company3c8f90e2-fecf-4439-9faa-81a32ffe47532024-09-26WarningsExact identifier
application number: M015
equate hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWal-Mart Stores Inc5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d2024-09-26WarningsExact identifier
application number: M015
Walgreens Hemorrhoidal Pain ReliefGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Walgreense79ed7ae-0d06-2f88-e053-2995a90a1e352024-09-20WarningsExact identifier
application number: M015
Soothe XP Preservative FreeLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedb254d885-6d49-4c95-b6be-cfdad49c85e62024-09-20WarningsExact identifier
unii: N6K5787QVP
Soothe XPLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedc0f053da-8d22-433e-a36e-79cf15ad387f2024-09-20WarningsExact identifier
unii: N6K5787QVP
hemorrhoidal reliefCOCOA BUTTER, PHENYLEPHRINE HCLRite Aid Corporationddafbdca-32c2-49c1-83d3-35b4155958c92024-08-15WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLRite Aid Corporation8e1f223a-a3a0-4837-9847-2a3939fcc5952024-08-15WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBryant Ranch Prepack485fd02f-bfea-41d0-90a1-f12fcfeb2a152024-08-14WarningsExact identifier
application number: M015
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Up and Up Hemorrhoid MAX STRENGTH14.4% GLYCERIN, 0.25% PHENYLEPHRINE HCL, 1% PRAMOXINE HCL, 15% PETROLATUMTarget Corporation867677b5-fd1d-449e-966e-1de0b5c98afb2024-08-08WarningsExact identifier
application number: M015
Soothing Hemorrhoidal Wipes 50 Witch HazelWITCH HAZELThe Honey Pot Company LLC1ea202f5-e228-b3f2-e063-6294a90a16c12024-08-01WarningsExact identifier
application number: M015
Vitamin A and DVITAMIN A AND DMIDWOOD BRANDS, LLC1d0ebe9a-cbc5-1765-e063-6294a90aa4762024-07-18WarningsExact identifier
unii: 7EV65EAW6H
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Bunnies Bum Hemorrhoidal NumbingLIDOCAINEFloCal Distributors LLC1c809643-0cbe-568f-e063-6394a90a32102024-07-05WarningsExact identifier
application number: M015
Bunnies Bum Soothing HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLFloCal Distributors LLC1c81582c-7ece-182f-e063-6294a90a8fbc2024-07-05WarningsExact identifier
application number: M015
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Dr. Mom Butt BalmDIMETHICONE PETROLATUMFerndale Laboratories, Inc.ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd2024-06-13WarningsExact identifier
unii: B6E5W8RQJ4
MegaBabe Butt Stuff HemorrhoidalCOCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEMEGABABE, LLC01c156ff-69f9-4d5e-a9ea-abbc52d4afff2024-06-12WarningsExact identifier
application number: M015

Reported adverse events (FAERS/openFDA)#

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