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 9 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibiotic Maximum StrengthBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWalgreens9a092f24-65b2-4b57-8103-265ea3e033112025-09-02WarningsExact identifier
application number: M004
AerosootheTRIPLE ANTIBIOTIC OINTMENTAero Healthcare US LLC2287a31c-750c-728d-e054-00144ff88e882025-08-29WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEChain Drug Marketing Association Inc.3d4b3d73-171a-bc6a-e063-6394a90a69c12025-08-26WarningsExact identifier
application number: M004
Dual Action CreamNEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCLTrifecta Pharmaceutical USA LLCb84015ae-9c76-b1d7-e053-2a95a90a2cc82025-08-23WarningsExact identifier
application number: M004
Natureplex Antibiotic Plus Pain, Itch, Scar ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDENatureplex LLCf0af8829-72fb-46b1-9328-6f4920710bb12025-08-15WarningsExact identifier
application number: M004
PROHEAL TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.6c61d88e-4ced-4468-8f99-91652f7a03e42025-08-13WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEJ&A Digital Inc.9f006f16-083d-4e95-aec2-6ef83405f3932025-08-07WarningsExact identifier
application number: M004
Vitacilina First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETaisho Pharmaceutical California Inc.93fb9e05-f78c-4d37-b6f1-926cbcb2e7a72025-08-07WarningsExact identifier
application number: M004
SurviveX Triple AntibioticTRIPLE ANTIBIOTIC OINTMENTNantong Health & Beyond Hygienic Products Inc.3bd25bb6-6486-8a0a-e063-6394a90a085c2025-08-07WarningsExact identifier
application number: M004
Thera Plus Original Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEFOURSTAR GROUP USA, INC.09e8bdb7-dc14-4f28-8306-c0e2bf73f0812025-07-31WarningsExact identifier
application number: M004
BacitracinBACITRACINBryant Ranch Prepack0c081802-429f-468f-9650-293cb7a1ad342025-07-29WarningsExact identifier
application number: M004
health and .beyond Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0070ea5f-434d-53a7-e063-6294a90abf182025-07-27WarningsExact identifier
application number: M004
health and beyond TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.13cbe416-a146-447d-be36-8b3af9b3c8952025-07-27WarningsExact identifier
application number: M004
AOSI HEALTHCARE TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.70c53369-7cf6-4352-a19f-c85a55c5a4bd2025-07-27WarningsExact identifier
application number: M004
Pomada de SulfaNEOMYCIN SULFATEMenper Distributors, Inc.216f4d22-e5e8-46c8-a4ef-8d1532792b562025-07-22WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATESTRATEGIC SOURCING SERVICES LLC1bda9c30-8fc8-4814-b211-94550672b22f2025-07-21WarningsExact identifier
application number: M004
Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC6a61c900-2dfc-4c07-8ae5-32ffbd89d2b62025-07-21WarningsExact identifier
application number: M004
FifthPulse Bacitracin Zinc 1ozBACITRACIN ZINCFront Pharmaceutical PLC39f994d4-5f41-fb34-e063-6294a90a45ea2025-07-15WarningsExact identifier
application number: M004
FifthPulse Bacitracin Zinc 4ozBACITRACIN ZINCFront Pharmaceutical PLC39fa0e5f-b794-e1e3-e063-6394a90a4ce32025-07-15WarningsExact identifier
application number: M004
FifthPulse Hydrocortisone 1ozHYDROCORTISONEFront Pharmaceutical PLC39fae2a4-902e-3c88-e063-6394a90acbd52025-07-15WarningsExact 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