FDA.reportPublic FDA data

VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC

Product NDC
54312-019
11-digit product format
543120019
Labeler code
54312
Product ID
54312-019_43fa588f-3f99-7492-e063-6294a90a5954
Type
HUMAN OTC DRUG
Nonproprietary name
NEOMYCIN SULFATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Compania Internacional de Comercio, S.A.P.I de C.V.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-07-30
Substance
NEOMYCIN SULFATE
Active strength
3.5 mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE3.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
057Y626693Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1544556Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ba7a3331-466e-496f-bebd-9ee7067bcdb2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54312-019-31VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC28 g in 1 TUBEOINTMENT2822
54312-019-31VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC1 in 1 CARTONOINTMENT122
54312-019-35VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC14 g in 1 TUBEOINTMENT1422
54312-019-35VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC1 in 1 CARTONOINTMENT122

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]3
NEOMYCINACTIVE MOIETYI16QD7X297VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]3
LANOLININACTIVE INGREDIENT7EV65EAW6HVITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TVITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UVITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHVITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]3
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCVITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54312-019VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]19Current NDC, Legacy NDC, 4 package rows20241219_ba7a3331-466e-496f-bebd-9ee7067bcdb2.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 17 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple Antibiotic plus pain reliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLKroger Companye31c8d92-bf9f-4b7f-8f81-54199745cd202024-10-06WarningsExact identifier
application number: M004
careone triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEAmerican Sales Company9df0c4c2-f045-4f25-878e-4d55a99b8df42024-10-06WarningsExact identifier
application number: M004
DG Health AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLDolgencorp, LLC0a04da51-d169-4eff-b70c-352913ce39662024-10-06WarningsExact identifier
application number: M004
Signature Care Triple AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLSafeway8d5bac6b-98b6-4fc4-983a-ca5292b4c3612024-10-06WarningsExact identifier
application number: M004
antibiotic plus pain reliefNEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEKroger Company91828614-d0d1-472f-802f-43f4738601252024-09-26WarningsExact identifier
application number: M004
DG Health AntibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLDolgencorp Incefaf3ea5-0a2f-414f-96eb-7e8cfba9e9012024-09-26WarningsExact identifier
application number: M004
Good Sense First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BA-S Medication Solutions29c223ff-3cb7-4578-a326-08516e89cd472024-09-26WarningsExact identifier
application number: M004
Signature Care First Aid AntibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLSafeway78ecfb28-f4c4-4f70-90c9-d6d7bf920fb52024-09-26WarningsExact identifier
application number: M004
Good Neighbor Pharmacy Antibiotic and Pain ReliefNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLAmerisource Bergen3d1694ea-3f3e-45d5-8edf-8b31ac7d3a402024-09-26WarningsExact identifier
application number: M004
Rexall AntibioticBACITRACINDolgencorp, LLC7ad42602-6e42-47c8-91a8-e4785fa8d24b2024-09-23WarningsExact identifier
application number: M004
bacitracinBACITRACINH E B0a5eeef0-309b-4edd-a664-3d9c1c74a6e92024-09-23WarningsExact identifier
application number: M004
signature care first aid antibioticBACITRACINSafeway38fc0c5c-e0bc-44d2-acbd-d4d329fef1e12024-09-23WarningsExact identifier
application number: M004
AntibioticBACITRACINTopco Associates LLC3267a695-9e53-42f2-b30a-022653a0b8bb2024-09-23WarningsExact identifier
application number: M004
BacitracinBACITRACINKroger Company4490cece-0635-4ea7-91ab-324a971fef632024-09-23WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BPadagis Israel Pharmaceuticals Ltd28fff253-ddd4-4669-aa90-b4caf48c905f2024-09-22WarningsExact identifier
application number: M004
Signature Care Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BSafeway044aff98-f398-40f5-8c18-2751b4ab43842024-09-18WarningsExact identifier
application number: M004
careone triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAmerican Sales Company09a0b0b9-1806-4ff9-80fa-448dabbf2cc72024-09-18WarningsExact identifier
application number: M004
equaline first aid antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BUnited Natural Foods, Inc. dba UNFI022e009e-0192-4089-86f3-4d63448e0f882024-09-18WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BKroger Companyc531bac4-ab15-4fde-99a7-19e20ce103872024-09-17WarningsExact identifier
application number: M004
basic care first aid antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BAmazon.com Services LLCc159b18d-0d6e-409f-8b2b-e8f28cd856332024-09-17WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544556neomycin sulfate 0.5 % Topical OintmentPSNba7a3331-466e-496f-bebd-9ee7067bcdb222
1544556neomycin sulfate 0.005 MG/MG Topical OintmentSCDba7a3331-466e-496f-bebd-9ee7067bcdb222
1544556neomycin sulfate 0.5 % Topical OintmentSYba7a3331-466e-496f-bebd-9ee7067bcdb222
1544556neomycin sulfate 5 MG/GM Topical OintmentSYba7a3331-466e-496f-bebd-9ee7067bcdb222

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54312-019-31543120019311 TUBE in 1 CARTON (54312-019-31) / 28 g in 1 TUBE1 tube2016-07-300000-00-00NoNoCurrent
54312-019-35543120019351 TUBE in 1 CARTON (54312-019-35) / 14 g in 1 TUBE1 tube2016-07-300000-00-00NoNoCurrent