FDA.reportPublic FDA data

NDC 71399-8455-08 - UREA

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
71399-8455
Requested NDC
71399-8455-08
Package NDCs from labels
71399-8455-8, 71399-8455-08
Manufacturer
AKRON PHARMA INC
Effective date
2024-09-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
UREA - AKRON PHARMA INCAKRON PHARMA INC2024-09-25HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-8455-82023-03-26C16284748780-1f386c64a-3b41-0266-e053-dadaa90a7c1aUrea Lotion 40%
71399-8455-82023-01-30C16284748780-1f386c64a-3b41-0266-e053-dadaa90a7c1aUrea Lotion 40%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-8455-8UREA227 g in 1 BOTTLELOTION2273

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-8455UREA (UREA) LOTION [AKRON PHARMA INC]3Current NDC, Legacy NDC, 1 package rows20240927_3c0d612a-2247-448d-ae65-f9abfd894158.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-8455-8GM - Gram71399-84551870219b-f085-4f16-ba84-9295d9ac0ffc12022-01-06

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 1 of 25 · 490 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OilMINERAL OILAtlantic Biologicals Corp.5a82197b-281d-76c0-e063-6294a90a57462026-09-02Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILYour Military Exchanges6025dce6-02e8-418c-a248-0b5c33ff60672026-08-28Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Supreme Care Protective Zinc CreamPROTECTIVE ZINC CREAMSupreme Products Corporation55f5f098-1732-0fb0-e063-6394a90a708b2026-08-25WarningsExact identifier
unii: B6E5W8RQJ4
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DawnMist White PetrolatumWHITE PETROLATUMDukal LLC598e9d46-6450-af60-e063-6394a90a3a6b2026-08-21WarningsExact identifier
unii: B6E5W8RQJ4
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP0073de92-585d-e01a-e063-6394a90a2ec22026-08-21WarningsExact identifier
unii: B6E5W8RQJ4
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5967ef02-6770-bfd7-e063-6294a90a79042026-08-19WarningsExact identifier
unii: T5L8T28FGP
unii: B6E5W8RQJ4
ClaraViePETROLATUMGentell LLC596987e4-4205-b911-e063-6294a90aa5702026-08-19WarningsExact identifier
unii: B6E5W8RQJ4
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5905b300-6f1f-a61f-e063-6394a90a11232026-08-14WarningsExact identifier
unii: T5L8T28FGP
unii: B6E5W8RQJ4
Mineral oilMINERAL OILEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)92f2147d-b52d-4282-b217-28f6095dca0e2026-08-12WarningsExact identifier
unii: T5L8T28FGP
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP087d66ff-1a8c-dcb2-e063-6294a90a2f8c2026-08-11WarningsExact identifier
unii: B6E5W8RQJ4
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dealmed Vitamins A and DWHITE PETROLATUMDealmed Medical Supplies, LLC.d6584809-b438-4b2c-ab37-522e0dbef4702026-08-05WarningsExact identifier
unii: B6E5W8RQJ4

Reported adverse events (FAERS/openFDA)#

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