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 15 of 22 · 422 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neosporin Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC32302dcd-f3f1-408b-ae5f-e7d8b666f68f2024-11-13WarningsExact identifier
application number: M004
NEOSPORIN Plus BURN RELIEFBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC3caa7fd1-bd66-427e-a6c0-1b137b2050892024-11-13WarningsExact identifier
application number: M004
Simply Neosporin First Aid AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATEKenvue Brands LLC68bfecea-095f-4d3f-b077-d86e1b9f1faa2024-11-13WarningsExact identifier
application number: M004
Triple Antibiotic and Burn ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDECVS Pharmacyfdc510b8-f3ad-4bd6-a8d0-1b81e9f30e132024-11-13WarningsExact identifier
application number: M004
BACITRACINBACITRACINALLIED TRADE LINK LLC253e5b98-c64f-3226-e063-6294a90a93522024-11-12WarningsExact identifier
application number: M004
TRIPLET ANTIBIOTICTRIPLET ANTIBIOTICALLIED TRADE LINK LLC26bd5ba4-264b-2a28-e063-6394a90ada802024-11-12WarningsExact identifier
application number: M004
basic care first aid antibiotic and burn reliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEAmazon.com Services LLC0df4c44d-6912-4db9-a703-a82da4c8ae762024-11-11WarningsExact identifier
application number: M004
SUPER SENSITIVE HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTY7d4a5b21-82d2-4904-9577-4a9b2579076e2024-11-08WarningsExact identifier
application number: M004
dg health triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLDolgencorp, LLC4c97dada-966f-4de8-b5d9-e939cb456aea2024-11-06WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BA-S Medication Solutionsde07139e-ece9-424b-8468-f5ed4bbb2b2b2024-11-06WarningsExact identifier
application number: M004
good sense triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLL. Perrigo Companye9e913d8-8ec8-4465-ad3a-b524f6710a0f2024-11-06WarningsExact identifier
application number: M004
EUCALYPTUS EASE HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTY09d77591-9472-4771-9090-3390bddf788a2024-11-06WarningsExact identifier
application number: M004
Triple AntibioticPOLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATEA-S Medication Solutionse115d413-e41c-4e43-8184-493d64dfcd9f2024-11-06WarningsExact identifier
application number: M004
LEMON MYRTLE HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTYf341b24c-9466-42f4-98fe-d1a1225919152024-11-06WarningsExact identifier
application number: M004
BacitracinBACITRACINA-S Medication Solutions00747e3a-389c-46bc-b6b9-9b3d1d98dbcf2024-11-06WarningsExact identifier
application number: M004
Signature Care Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLSafeway46db4b66-85a2-47fc-a643-df6477e2ddff2024-11-06WarningsExact identifier
application number: M004
CALMING HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTYffcbe34d-3c53-47f9-9e4a-b5448afbbd5d2024-11-05WarningsExact identifier
application number: M004
Antibiotic, Pain and ScarBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLCVS Pharmacy8bb6cb64-103f-454a-95ad-c2c56b9cf71a2024-11-05WarningsExact identifier
application number: M004
BACITRACINBACITRACINMeijer Distribution Inc029e7150-1b9a-47c9-90bd-5f8bcd21365c2024-10-29WarningsExact identifier
application number: M004
SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEFPOLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEA-S Medication Solutions01131ba6-6d5b-4710-bec3-ba1769c08c792024-10-22WarningsExact 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