FDA.reportPublic FDA data

NDC 0168-0029 - Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate

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
0168-0029
Package NDCs from labels
0168-0029-38
Manufacturer
Rebel Distributors Corp
Effective date
2011-01-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Neomycin Sulfate - Rebel Distributors CorpRebel Distributors Corp2011-01-03HUMAN PRESCRIPTION DRUG LABEL
NEOMYCIN SULFATE - Physicians Total Care, Inc.Physicians Total Care, Inc.2010-05-11HUMAN PRESCRIPTION DRUG LABEL
Neomycin Sulfate - E. FOUGERA and CO.E. FOUGERA and CO.2006-09-12HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0029-38Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate3.5 g in 1 TUBEOINTMENT3.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0029NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [E. FOUGERA AND CO.]11 package rows20061027_cc2f489e-a75d-47dc-96d1-7f05bc6b7197.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
BACITRACINACTIVE MOIETY58H6RWO52INEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16BNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
Bacitracin zincACTIVE INGREDIENT89Y4M234ESNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [E. FOUGERA AND CO.]1
Bacitracin zincACTIVE INGREDIENT89Y4M234ESNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
Hydrocortisone AcetateACTIVE INGREDIENT3X7931PO74NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [E. FOUGERA AND CO.]1
Hydrocortisone AcetateACTIVE INGREDIENT3X7931PO74NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
Neomycin SulfateACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [E. FOUGERA AND CO.]1
Neomycin SulfateACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [E. FOUGERA AND CO.]1
bacitracinACTIVE MOIETY58H6RWO52INEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [E. FOUGERA AND CO.]1
bacitracinACTIVE MOIETY58H6RWO52INEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
hydrocortisoneACTIVE MOIETYWI4X0X7BPJNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [E. FOUGERA AND CO.]1
hydrocortisoneACTIVE MOIETYWI4X0X7BPJNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
neomycinACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
neomycinACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [E. FOUGERA AND CO.]1
polymyxin BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [E. FOUGERA AND CO.]1
polymyxin BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
mineral oilINACTIVE INGREDIENTNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [E. FOUGERA AND CO.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
white petrolatumINACTIVE INGREDIENTNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [E. FOUGERA AND CO.]1
Zinc chlorideINACTIVE INGREDIENT86Q357L16BNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [E. FOUGERA AND CO.]1
Zinc chlorideINACTIVE INGREDIENT86Q357L16BNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1

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 33 of 59 · 1,178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BacitracinBACITRACIN ZINCTrifecta Pharmaceuticals USA, LLC.4a9fe0fa-5549-4e06-e054-00144ff8d46c2025-05-15WarningsExact identifier
unii: 89Y4M234ES
SionBiotext HydrocortisoneHYDROCORTISONE ACETATE 1%Sion Biotext Medical Ltd35073eae-26fe-2bb5-e063-6294a90ab56a2025-05-13WarningsExact identifier
unii: 3X7931PO74
SionBiotext Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESion Biotext Medical Ltd35083d42-5823-eeb1-e063-6294a90acafa2025-05-13WarningsExact identifier
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
Multi ActionBACITRACINZINC,NEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCLTrifecta Pharmaceutical USA LLCb98082f3-be95-49fb-e053-2a95a90a37b82025-05-13WarningsExact identifier
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
Leader Triple antibiotic and pain reliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINECardinal Health 110 dba LEADERf4c521d9-dd05-1c23-e053-2995a90a6e2c2025-05-13WarningsExact identifier
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
TripleantibioticointmentandpainreliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINETrifecta Pharmaceuticals USA34f1db74-6506-d53d-e063-6394a90ac4002025-05-12WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Polymyxin BPOLYMYXIN BEugia US LLCa974c557-e88f-451b-a1bd-d2c656be226e2025-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 19371312D4
POLYMYXIN BPOLYMYXIN B SULFATEGland Pharma Limiteddc74dee2-1d0b-4fab-a29b-1755fdb5da752025-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 19371312D4
LANOZEM HEMORRHOIDALMENTHOL, PETROLATUMSod-e Biotech Ltd34901e83-8f24-8460-e063-6394a90a27442025-05-07WarningsExact identifier
unii: 4T6H12BN9U
ChapIce Moisture SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMOraLabs1fcc1d6e-71b8-4f2f-8794-b3d013ad4ea72025-05-07WarningsExact identifier
unii: 4T6H12BN9U
Perfect 10 Soothing RecoveryPETROLATUMTopiderm, Inc.e3a4f038-d084-4d77-bd35-13f41856a6152025-04-30WarningsExact identifier
unii: 4T6H12BN9U
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEBausch & Lomb Incorporatedb0ee85dd-5fe1-46a3-9bff-606e489d20b12025-04-30Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
OraLabs ChapIce Original PetrolatumPETROLATUMOraLabs54729693-f0e2-48ad-881a-a07986ed823b2025-04-30WarningsExact identifier
unii: 4T6H12BN9U
Sunfrog Ultra SPF 30 Lip BalmOCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLYOraLabs61299626-bf60-40e8-a2d3-4d4a99d8d15c2025-04-30WarningsExact identifier
unii: 4T6H12BN9U
ChapIce Moisture SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMNavajo Manufacturing Company Inc.60ce1a8c-180a-161e-e053-2991aa0ae9812025-04-29WarningsExact identifier
unii: 4T6H12BN9U
OraLabs ChapIce Cherry PetrolatumPETROLATUMOraLabsf0d9d01e-bfdf-4e33-abfb-f683d414d8082025-04-29WarningsExact identifier
unii: 4T6H12BN9U
PROCORT1.85% HYDROCORTISONE ACETATE - 1.15% PRAMOXINE HCI CREAMWomens Choice Pharmaceuticals LLC9e899b72-a16e-4b55-93b5-ab5baec37d502025-04-28Adverse reactionsExact identifier
unii: 3X7931PO74
Triple Antibiotic plus LidocaineBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE, LIDOCAINETRIFECTA PHARMACEUTICALS USA LLC14fda967-54ba-c964-e063-6294a90a21ee2025-04-24WarningsExact identifier
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
SPF 45 - Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMOraLabsafd10abe-1e8b-4df8-9d8c-ef15266c510c2025-04-22WarningsExact identifier
unii: 4T6H12BN9U
OraLabs SPF 15 Lip BalmAVOBENZONE, OCTINOXATE, PETROLATUMOraLabs3ac8569f-4b11-4536-8919-234f79bbd7fc2025-04-22WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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