NDC 47046-161-01 - Triple Antibiotic

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
47046-161
Requested NDC
47046-161-01
Package NDCs from labels
47046-161-01, 47046-161-02
Manufacturer
Anicare Pharmaceuticals Pvt. Ltd
Effective date
2020-12-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Triple Antibiotic - Anicare Pharmaceuticals Pvt. LtdAnicare Pharmaceuticals Pvt. Ltd2020-12-13HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47046-161-022022-01-28C16284748780-1d6a99b3a-008d-a426-e053-dadaa90af4c2b65ec35f-fa2f-0cfe-e053-2995a90adcac

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47046-161-01Triple Antibiotic14.2 g in 1 TUBEOINTMENT14.21
47046-161-02Triple Antibiotic1 in 1 CARTONOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47046-161TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE) OINTMENT [ANICARE PHARMACEUTICALS PVT. LTD]1Legacy NDC, 2 package rows20201215_b65ec35f-fa2f-0cfe-e053-2995a90adcac.zip

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 52 of 54 · 1,065 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin SulfateNEOMYCIN SULFATETeva Pharmaceuticals USA, Inc.777dbfab-f83e-4738-ae1e-78619a9f82a72022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 057Y626693
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEProficient Rx LP548089f3-29d8-4ba8-af21-9e04356ac29c2022-10-01Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEProficient Rx LPf5ef71ae-fca9-4a57-ae88-f2b2d195a1792022-08-01Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
BHI SkinBERBERIS VULGARIS ROOT BARK, GRAPHITE, HYDROFLUORIC ACID, LYCOPODIUM CLAVATUM SPORE, PETROLATUM, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, AND SULFURMediNatura Inc70ab2931-bd2d-43de-bb36-d019f78e3d732022-07-07WarningsExact identifier
unii: 4T6H12BN9U
REFRESH P.M.MINERAL OIL, PETROLATUMAllergan, Inc.24365d64-cd94-41cc-a7e1-033102d981142022-06-30WarningsExact identifier
unii: 4T6H12BN9U
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEProficient Rx LP98042cef-2839-49d6-a7bd-a1d29c74430b2022-05-02Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEProficient Rx LP601cab21-c211-4c34-be7b-f4fdd97a921a2022-05-02Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
Polymyxin BPOLYMYXIN B SULFATEHikma Pharmaceuticals USA Inc.18daf0d1-b6f5-46f4-ab2f-01a594f3959c2022-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIMProficient Rx LP1252b997-3a81-4f3c-90e4-92f29ba157132022-04-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEProficient Rx LPd1f55327-156f-44cd-b0fc-b1a938e8aa732022-04-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
CuadridermaBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEProMex LLC4fa99b96-ab4b-4523-82bc-343dbaf39fb62022-01-25WarningsExact identifier
unii: 89Y4M234ES
unii: 057Y626693
unii: 19371312D4
GUNA LIVER PLUSSODIUM PYRUVATE - SILYBUM MARIANUM SEED - CHELIDONIUM MAJUS - FUMARIC ACID - PORK LIVER - TARAXACUM OFFICINALE - LYCOPODIUM CLAVATUM SPORE - SODIUM SULFATE - PHOSPHORUS - BERBERIS VULGARIS ROOT BARKGuna spaba44c46e-4509-2e4d-e053-2a95a90a9c952021-12-15WarningsExact identifier
unii: POD38AIF08
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONESandoz Inc96a7b0a5-030a-42dc-80cd-35c4e9aa1b6d2021-08-31Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONESandoz Inc.99d9030f-9118-412c-a377-d1df1c8fa7232021-08-31Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
POLYMYXIN BPOLYMYXIN B SULFATEFresenius Kabi USA, LLC704a41f5-b109-4c16-8d3e-1495c99179522021-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 19371312D4
POLYMYXIN BPOLYMYXIN B SULFATEFresenius Kabi USA, LLCfbc12c18-567b-41bc-89d0-efd29616615c2021-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONEProficient Rx LPbd9f3220-6d42-4863-aa2a-b17b138d095d2021-01-01Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
Trimethoprim sulfate and Polymyxin B sulfateTRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATEProficient Rx LP2c5579eb-ad81-415e-8dcb-9f1c94c897ae2021-01-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONEProficient Rx LPd55f1783-9c49-4f90-9ff8-6f132e7b325e2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEProficient Rx LPaa7b8a3f-06dd-4190-96a5-f86195bd21972021-01-01Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

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