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 32 of 59 · 1,178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pramosone CreamHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc.6a9fb75b-a2f7-4eca-8dce-d7eb5c1224762025-06-30Adverse reactionsExact identifier
unii: 3X7931PO74
Analpram HCHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc.39618fc5-87a8-47bc-93fc-cb97b8f663c82025-06-24Adverse reactionsExact identifier
unii: 3X7931PO74
Walgreens Healing Balm Skin ProtectantPETROLATUMWalgreensbc585145-3588-446e-926f-e6baf43ca4ba2025-06-24WarningsExact identifier
unii: 4T6H12BN9U
Meret Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.385d8642-9eae-a750-e063-6394a90a79312025-06-24WarningsExact identifier
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
ProCure Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETwin Med LLC37a3916f-cc1a-41a0-e063-6394a90a35ed2025-06-16WarningsExact identifier
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
Bacitracin ZincFIRST AID ANTIBIOTICDynarex Corporation82cf8dd0-eef6-5871-e053-2991aa0a38cf2025-06-16WarningsExact identifier
unii: 89Y4M234ES
ProCure HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTwin Med LLC37a4cc43-0d53-f1bf-e063-6394a90a2dc92025-06-15WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Sion Biotext Bacitracin ZincBACITRACIN ZINCSion Biotext Medical Ltd35056345-f325-99e8-e063-6294a90a2d7e2025-06-12WarningsExact identifier
unii: 89Y4M234ES
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF OINTMENTNeilmed Pharmaceuticals Inc.374d89b6-9305-9adf-e063-6394a90adb322025-06-11WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLC4eb3c9ac-268a-5246-e054-00144ff88e882025-06-09WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Analpram HCHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc.56568e1f-974b-4750-b560-d93eb5e0e83f2025-06-09Adverse reactionsExact identifier
unii: 3X7931PO74
PramosoneHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc.4c98a01e-ff11-45eb-8732-4bd9157969e82025-06-09Adverse reactionsExact identifier
unii: 3X7931PO74
PramosoneHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc.ce3dd32c-1262-454e-aacb-880d54596dd32025-06-09Adverse reactionsExact identifier
unii: 3X7931PO74
ProCure Bacitracin ZincBACITRACIN ZINCTwin Med LLC36da7993-7c65-7430-e063-6294a90a06262025-06-05WarningsExact identifier
unii: 89Y4M234ES
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, POLYMYXIN BJ&A Digital Inc.9b8f2046-5886-440d-a7fc-a71138d7f34b2025-06-02WarningsExact identifier
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
Orajel Rescue Relief PenORAL PAIN RELIEVERChurch & Dwight Co., Inc.2d68eec5-ae8a-9cdf-e063-6294a90a97992025-06-01WarningsExact identifier
unii: 86Q357L16B
POLYMYXIN BPOLYMYXIN B SULFATEFOSUN PHARMA USA INCfd664927-db58-a1af-e053-6294a90a90482025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Bestmade Natural Products Zinc Chloride (Zinc Mur)ZINC CHLORIDEBestmade Natural Products2fadb4c6-9f66-f4fd-e063-6394a90a14f22025-05-26WarningsExact identifier
unii: 86Q357L16B
Mineral OilMINERAL OILATLANTIC BIOLOGICALS CORP.960502ae-2468-406e-8799-cacb01f2727e2025-05-23WarningsExact identifier
unii: T5L8T28FGP
Polymyxin BPOLYMYXIN B SULFATEHikma Pharmaceuticals USA Inc.d2bf65f6-2763-4859-a665-ad5e6cde71ee2025-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

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