FDA.reportPublic FDA data

Neomycin

Product NDC
67777-218
11-digit product format
677770218
Labeler code
67777
Product ID
67777-218_0f9e087b-6e87-a3c7-e063-6394a90ac8d4
Type
HUMAN OTC DRUG
Nonproprietary name
Neomycin Ointment
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-30
Substance
NEOMYCIN SULFATE
Active strength
5 mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Neomycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE5 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
0f9e087b-6e86-a3c7-e063-6394a90ac8d4Available 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
67777-218-01Neomycin1000 in 1 CASEOINTMENT10001
67777-218-02Neomycin0.9 g in 1 PACKETOINTMENT0.91
67777-218-02Neomycin10 in 1 BOXOINTMENT101
67777-218-03Neomycin1800 in 1 CASEOINTMENT18001
67777-218-04Neomycin0.9 g in 1 PACKETOINTMENT0.91
67777-218-04Neomycin25 in 1 BOXOINTMENT251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-218NEOMYCIN (NEOMYCIN OINTMENT) OINTMENT [DYNAREX CORPORATION]1Current NDC, 6 package rows20240130_0f9e087b-6e86-a3c7-e063-6394a90ac8d4.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 7 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand-AidALCOHOLABC Compounding Co., Inc.788d7584-bc33-49e8-90fd-767045ea29142025-11-19WarningsExact identifier
application number: M004
VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTICNEOMYCIN SULFATECompania Internacional de Comercio, S.A.P.I de C.V.ba7a3331-466e-496f-bebd-9ee7067bcdb22025-11-19WarningsExact identifier
application number: M004
dabur First AidBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEDabur India Limited229170a3-ef9e-597d-e063-6394a90acf8b2025-11-18WarningsExact identifier
application number: M004
QS Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDERomaine Companies5e16f52d-3bf3-4897-bd3a-cf4e117583c92025-11-18WarningsExact identifier
application number: M004
Hand Guard Foaming Instant Hand SanitizerALCOHOLWechem, Inc.d9b89f90-aece-48a2-862a-c524d3c908412025-11-18WarningsExact identifier
application number: M004
Puri-San Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDEPeople's Janitorial Supplyf0726bdd-9d2b-4383-af10-e2e0c5460e1e2025-11-18WarningsExact identifier
application number: M004
Lynx san a foamALCOHOLABC Compounding Co., Inc.2b987ebc-c73b-edbd-e063-6394a90a1d2d2025-11-18WarningsExact identifier
application number: M004
Instant Hand SanitizerALCOHOLABC Compounding Co., Inc.ee46cb57-c79c-4edf-bc88-4a4f8a95bfc82025-11-18WarningsExact identifier
application number: M004
Rapidol Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPharmadel LLC1ad22205-f8c3-b142-e063-6394a90a00442025-11-17WarningsExact identifier
application number: M004
BacitracinBACITRACINKroger3f860e7f-487b-d706-e063-6394a90a73ad2025-11-13WarningsExact identifier
application number: M004
ElixirBaciShield First AidBACITRACIN ZINCELIXIR HEALTHCARE USA, LLC.15e31a2a-01b5-4598-850f-4d0348086b4b2025-11-12WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLC4352c453-a89c-a2b9-e063-6294a90a61f32025-11-11WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCUniversal Distribution Center LLC186b2750-5bf6-1702-e063-6294a90a62b32025-10-30WarningsExact identifier
application number: M004
POMADA SULFA FIRST AID ANTIBIOTICNEOMYCIN SULFATEGRANDALL DISTRIBUTING, LLC1d8e1fca-6864-7c08-e063-6394a90a08b62025-10-28WarningsExact identifier
application number: M004
POLVO DE SULFA FIRST AID ANTIBIOTICBACITRACIN ZINC, POLYMYXIN B SULFATEGRANDALL DISTRIBUTING, LLC1d8e3a03-a39f-a99e-e063-6394a90a31db2025-10-28WarningsExact identifier
application number: M004
EasyTouch Alcohol Prep Pads SterileISOPROPYL ALCOHOLMHC Medical Products, LLCfd60ad34-5fd9-4440-9f3f-23beffc19dd92025-10-24WarningsExact identifier
application number: M004
Gerigentle-Bacitracin zincBACITRACIN ZINCGeri-Gentle Corporation7e36e4d0-eac3-4aa3-81a7-e21c224b1cd42025-10-23WarningsExact identifier
application number: M004
TripleantibioticointmentandpainreliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINETrifecta Pharmaceuticals USA54c1d306-dc3b-2885-e054-00144ff8d46c2025-10-22WarningsExact identifier
application number: M004
Zapotol BacitracinBACITRACINZapatol Corp.c8704895-8819-49ac-8baa-5b97be1d00aa2025-10-22WarningsExact identifier
application number: M004
Family Care First AidBACITRACIN ZINCUnited Exchange Corp.df27620e-7312-8082-e053-2995a90aaca62025-10-21WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544556neomycin sulfate 0.5 % Topical OintmentPSN0f9e087b-6e86-a3c7-e063-6394a90ac8d41
1544556neomycin sulfate 0.005 MG/MG Topical OintmentSCD0f9e087b-6e86-a3c7-e063-6394a90ac8d41
1544556neomycin sulfate 0.5 % Topical OintmentSY0f9e087b-6e86-a3c7-e063-6394a90ac8d41
1544556neomycin sulfate 5 MG/GM Topical OintmentSY0f9e087b-6e86-a3c7-e063-6394a90ac8d41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67777-218-01677770218011000 BOX in 1 CASE (67777-218-01) / 10 PACKET in 1 BOX (67777-218-02) / .9 g in 1 PACKET1000 box2024-01-30NoNoCurrent
67777-218-02677770218020.9 g in 1 PACKET0.9 gHistorical
67777-218-03677770218031800 BOX in 1 CASE (67777-218-03) / 25 PACKET in 1 BOX (67777-218-04) / .9 g in 1 PACKET1800 box2024-01-30NoNoCurrent
67777-218-04677770218040.9 g in 1 PACKET0.9 gHistorical