NDC 0924-5603-01 - 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
0924-5603
Requested NDC
0924-5603-01
Package NDCs from labels
0924-5603-01, 0924-5603-03, 0924-5603-08, 0924-5603-09, 0924-5603-10, 0924-5603-11, 0924-5603-12, 0924-5603-04, 0924-5603-05, 0924-5603-06, 0924-5603-07, 0924-5603-02
Manufacturer
Acme United Corporation | Safetec of America, Inc.
Effective date
2016-03-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
triple antibiotic - Acme United Corporation | Safetec of America, Inc.Acme United Corporation | Safetec of America, Inc.2016-03-09HUMAN OTC DRUG LABEL
triple antibiotic - Acme United Corporation | Safetec of America, Inc.Acme United Corporation | Safetec of America, Inc.2012-03-28HUMAN OTC DRUG LABEL
triple antibiotic - Acme United Corporation | Safetec of America, Inc.Acme United Corporation | Safetec of America, Inc.2012-01-27HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-5603-01triple antibiotic0.5 g in 1 PACKETOINTMENT0.55
0924-5603-03triple antibiotic10 in 1 BOXOINTMENT105
0924-5603-08triple antibiotic10 in 1 BOXOINTMENT105
0924-5603-09triple antibiotic12 in 1 BOXOINTMENT125
0924-5603-10triple antibiotic60 in 1 BOXOINTMENT605
0924-5603-11triple antibiotic144 in 1 BOXOINTMENT1445
0924-5603-12triple antibiotic25 in 1 BOXOINTMENT255
0924-5603-01triple antibiotic0.5 g in 1 PACKETOINTMENT0.51
0924-5603-01triple antibiotic0.5 g in 1 PACKETOINTMENT0.51
0924-5603-02triple antibiotic6 in 1 BAGOINTMENT61
0924-5603-04triple antibiotic12 in 1 BOXOINTMENT121
0924-5603-05triple antibiotic25 in 1 BOXOINTMENT251
0924-5603-06triple antibiotic60 in 1 BOXOINTMENT601
0924-5603-07triple antibiotic144 in 1 BOXOINTMENT1441

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5603TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]5Legacy NDC, 7 package rows20160310_dea732fa-524b-4f75-bfee-285c30e74bdc.zip
0924-5603TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]1Legacy NDC, 5 package rows20120330_2ac1f9bb-2766-47eb-b25d-ac70f671a309.zip
0924-5603TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]1Legacy NDC, 2 package rows20120131_fe15585f-147b-4e14-9ba3-7c5a1a9a7e74.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
bacitracin zincACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]3
neomycin sulfateACTIVE INGREDIENT057Y626693TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]3
polymyxin b sulfateACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]3
bacitracinACTIVE MOIETY58H6RWO52ITRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]3
neomycinACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]3
polymyxin bACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]3
petrolatumINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]3
bacitracin zincACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]1
bacitracin zincACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]1
neomycin sulfateACTIVE INGREDIENT057Y626693TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]1
neomycin sulfateACTIVE INGREDIENT057Y626693TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]1
polymyxin b sulfateACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]1
polymyxin b sulfateACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]1
bacitracin zincACTIVE MOIETY89Y4M234ESTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]1
bacitracin zincACTIVE MOIETY89Y4M234ESTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]1
neomycinACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]1
neomycinACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]1
polymyxin bACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]1
polymyxin bACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ACME UNITED CORPORATION]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 48 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONEAsclemed USA, Inc.7c78ec84-8b7c-42f1-a879-3bf27a1daa712020-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
Resurfix PlusPETROLATUMTopiderm, Inc.f100f43d-6ace-4c3a-9c85-640c0ab2e3602019-11-19WarningsExact identifier
unii: 4T6H12BN9U
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
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

Reported adverse events (FAERS/openFDA)#

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