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 59 of 59 · 1,178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PetrolatumPETROLATUMGreenbrier International, Inc.91f24a0c-276f-4962-8da8-462b1f42040e2019-05-17WarningsExact identifier
unii: 4T6H12BN9U
PetrolatumPETROLATUMGreenbrier International, Inc.b8832ee7-3e13-456b-b301-dad7473a032b2019-02-04WarningsExact identifier
unii: 4T6H12BN9U
GUNA-DIZZY.ALPHA.-KETOGLUTARIC ACID - AMBERGRIS - ANAMIRTA COCCULUS SEED - CONIUM MACULATUM FLOWERING TOP - EPINEPHRINE - FUMARIC ACID - MALIC ACID - MELATONIN - MINERAL OIL - PTERIDIUM AQUILINUM ROOT - PYRIDOXINE HYDROCHLORIDE - QUINHYDRONE - QUININE - SUS SCROFA ARTERY - SUS SCROFA CEREBELLUM - SUS SCROFA PLACENTA - THIAMINE HYDROCHLORIDE - TOBACCO LEAF -Guna spac5f4a798-e628-4388-a98d-7449dd92f2d62018-12-21WarningsExact identifier
unii: T5L8T28FGP
BALMEX MULTI-PURPOSEPETROLATUMRandob Labs,Ltd.83a9ba1a-b708-47e2-a4a3-ef847e1bb7922018-11-13WarningsExact identifier
unii: 4T6H12BN9U
VUSIONMICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUMMylan Pharmaceuticals Inc.b44b452d-3630-4cb5-8ed1-1f8edac4690c2018-08-15Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
VUSIONMICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUMMylan Pharmaceuticals Inc.b026bc7d-3a18-41e8-88c4-1e063cd2f42c2018-08-14Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Natures Choice Vitamins A and DA AND D OINTMENTUnipack, Inc.17861122-2231-4a54-b3d8-894153c708d72018-01-15WarningsExact identifier
unii: 4T6H12BN9U
Water-Jel 3-in-1 AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATEWater-Jel Technologiesd5fcaffd-af38-4285-a79c-6df7424c76fa2017-11-16WarningsExact identifier
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
Vitamin A and DLANOLIN AND PETROLATUMFamily Dollar Services Inc4826b36d-3326-4f5c-8b22-c5ff79e550622017-11-08WarningsExact identifier
unii: 4T6H12BN9U
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: 4T6H12BN9U
CVS Triple AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN BCVS Pharmacy454bfeed-f58f-003a-e054-00144ff8d46c2017-01-04WarningsExact identifier
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
CVS Health Original SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMCVS6d58a18c-62ba-4cee-b3cc-51db746ba50e2016-09-14WarningsExact identifier
unii: 4T6H12BN9U
CVS Health Cherry SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMCVS84a621fe-890e-4c88-9f26-f013c32b52b72016-09-14WarningsExact identifier
unii: 4T6H12BN9U
CVS Health Cherry SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMCVSbfbf0241-51a6-4d9d-bee1-741d1645037d2016-09-14WarningsExact identifier
unii: 4T6H12BN9U
CVS Health Original SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMCVSe49680bd-bd61-40cf-abc8-51a1c88087262016-09-14WarningsExact identifier
unii: 4T6H12BN9U
bdee074e-e813-4403-897c-1ccb32bd6548bdee074e-e813-4403-897c-1ccb32bd65482011-01-03Warnings, Adverse reactionsExact identifier
spl id: bdee074e-e813-4403-897c-1ccb32bd6548
spl set id: bdee074e-e813-4403-897c-1ccb32bd6548
8f85671a-7f36-42ac-b237-feef70a67864e76c3a5a-d417-473b-ab9a-165d9d9963c62010-05-11Warnings, Adverse reactionsExact identifier
spl id: 8f85671a-7f36-42ac-b237-feef70a67864
spl set id: e76c3a5a-d417-473b-ab9a-165d9d9963c6
cc2f489e-a75d-47dc-96d1-7f05bc6b7197cc2f489e-a75d-47dc-96d1-7f05bc6b71972006-09-12Warnings, Adverse reactionsExact identifier
spl id: cc2f489e-a75d-47dc-96d1-7f05bc6b7197
spl set id: cc2f489e-a75d-47dc-96d1-7f05bc6b7197

Reported adverse events (FAERS/openFDA)#

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