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 12 of 22 · 422 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Honestly Battleborn First Aid for Real ManTETRACYCLINE HYDROCHLORIDEHONESTLY LLC13c1f2df-ba52-45e0-8868-a7518e9cdb552025-04-07WarningsExact identifier
application number: M004
Honestly Battleborn First Aid for Real ManTETRACYCLINE HYDROCHLORIDEHONESTLY LLC93a6e02e-9f4b-4821-afa2-2029769f30882025-04-07WarningsExact identifier
application number: M004
burn gel 01MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILCosmuses Cosmetics (Ningbo) Co., Ltd.3227bdc9-9323-68eb-e063-6294a90a29d22025-04-06WarningsExact identifier
application number: M004
Vitastem ULTRABACITRACIN ZINCViaDerma Distribution, Incfd96cc09-8522-44a5-b034-0d30e532410d2025-04-03WarningsExact identifier
application number: M004
Vitastem Ultra First Aid AntibioticBACITRACIN ZINCViaderma Distribution Ince6986bf9-22ea-4484-a709-27bc91c9058d2025-03-18WarningsExact identifier
application number: M004
Redicare Triple Antibiotic First AidTRIPLE ANTIBIOTIC FIRST AID OINTMENTRedicare LLC9468979d-446e-e4be-e053-2995a90a3f212025-03-05WarningsExact identifier
application number: M004
Neosporin OriginalBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEKenvue Brands LLC0ad21575-0e2d-24c2-e063-6394a90a616e2025-02-21WarningsExact identifier
application number: M004
The Life Safety Pro Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.64a7331f-98a6-4052-85b9-695c83b3bd162025-02-19WarningsExact identifier
application number: M004
VitastemTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.a6630858-7038-425f-8a75-bb25f36a0dbe2025-02-18WarningsExact identifier
application number: M004
Sheffield Triple AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATESheffield Pharmaceuticals LLC1aa95046-c1f7-4fc7-acac-839065d998f62025-02-17WarningsExact identifier
application number: M004
EquateBACITRACIN ZINC ANTIBIOTIC OINTMENTWalmart Inc.20908780-8803-4e19-e063-6394a90aab872025-02-01WarningsExact identifier
application number: M004
Tetracyte Topical Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC0961b097-ba41-40c2-aaec-dd291841bf092025-01-30WarningsExact identifier
application number: M004
AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWelly Health PBC9446375d-4bb4-4bb1-bdc2-c18e995bfe262025-01-29WarningsExact identifier
application number: M004
FAK Care4 Bus and School Yellow ORM DBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.3b5d07c6-bda2-4bc7-89b8-88280d11ed742025-01-22WarningsExact identifier
application number: M004
Members Mark Alcohol Prep Pads, SterileISOPROPYL ALCOHOLSam's Club West Inc.13001877-ae90-40be-899d-fb38f3a38b122025-01-22WarningsExact identifier
application number: M004
Equate Antibiotic Plus Pain, Itch, Scar ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMart2b743271-4f58-4ba1-a04c-560f7f8a547e2025-01-16WarningsExact identifier
application number: M004
Equate Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMarte08b427f-d070-4521-ad3c-faf2955317912025-01-16WarningsExact identifier
application number: M004
NATUREPLEX ANTIBIOTICBACITRACIN ZINC AND POLYMYXIN B SULFATENatureplex LLC86ea3452-c810-4c9a-9f52-bcb0688020f92025-01-15WarningsExact identifier
application number: M004
Balma Septic Antiseptic Hand WashBENZALKONIUM CHLORIDERochester Midland Corporation1b8e0a27-dcdd-4d07-b0f2-55cf74a9b5282025-01-10WarningsExact identifier
application number: M004
LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380CHLOROXYLENOLABC Compounding Co., Inc.efa3938f-64de-77ba-e053-2a95a90ac8402025-01-10WarningsExact 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