FDA.reportPublic FDA data

bacitracin zinc, neomycin sulfate and polymyxin b sulfate

Product NDC
67777-217
11-digit product format
677770217
Labeler code
67777
Product ID
67777-217_5c2bc061-a88e-dfc1-e063-6294a90a4645
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate and polymyxin b sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-12-01
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 5; 5000 [iU]/g; mg/g; [iU]/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage67777-217-02
excluded packagepackage67777-217-05
excluded packagepackage67777-217-07
excluded packagepackage67777-217-01

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
bacitracin zinc, neomycin sulfate and polymyxin b sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [iU]/g
NEOMYCIN SULFATE5 mg/g
POLYMYXIN B SULFATE5000 [iU]/g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
67777-217-012022-11-171180 Triple Antibiotic Ointment 0.5 g NDC 67777-217-05, 1182 Triple Antibiotic Ointment 0.9 g NDC 67777-217-07 1184 Triple Antibiotic Ointment 14.17 g NDC 67777-217-02, 1185 Triple Antibiotic Ointment 28.35 g NDC 67777-217-01 1180UB-10 Triple Antibiotic Ointment 0.5 g NDC 67777-217
67777-217-012022-11-171180 Triple Antibiotic Ointment 0.5 g NDC 67777-217-05, 1182 Triple Antibiotic Ointment 0.9 g NDC 67777-217-07 1184 Triple Antibiotic Ointment 14.17 g NDC 67777-217-02, 1185 Triple Antibiotic Ointment 28.35 g NDC 67777-217-01 1180UB-10 Triple Antibiotic Ointment 0.5 g NDC 67777-217
67777-217-022022-11-171180 Triple Antibiotic Ointment 0.5 g NDC 67777-217-05, 1182 Triple Antibiotic Ointment 0.9 g NDC 67777-217-07 1184 Triple Antibiotic Ointment 14.17 g NDC 67777-217-02, 1185 Triple Antibiotic Ointment 28.35 g NDC 67777-217-01 1180UB-10 Triple Antibiotic Ointment 0.5 g NDC 67777-217
67777-217-022022-11-171180 Triple Antibiotic Ointment 0.5 g NDC 67777-217-05, 1182 Triple Antibiotic Ointment 0.9 g NDC 67777-217-07 1184 Triple Antibiotic Ointment 14.17 g NDC 67777-217-02, 1185 Triple Antibiotic Ointment 28.35 g NDC 67777-217-01 1180UB-10 Triple Antibiotic Ointment 0.5 g NDC 67777-217
67777-217-052022-11-171180 Triple Antibiotic Ointment 0.5 g NDC 67777-217-05, 1182 Triple Antibiotic Ointment 0.9 g NDC 67777-217-07 1184 Triple Antibiotic Ointment 14.17 g NDC 67777-217-02, 1185 Triple Antibiotic Ointment 28.35 g NDC 67777-217-01 1180UB-10 Triple Antibiotic Ointment 0.5 g NDC 67777-217
67777-217-052022-11-171180 Triple Antibiotic Ointment 0.5 g NDC 67777-217-05, 1182 Triple Antibiotic Ointment 0.9 g NDC 67777-217-07 1184 Triple Antibiotic Ointment 14.17 g NDC 67777-217-02, 1185 Triple Antibiotic Ointment 28.35 g NDC 67777-217-01 1180UB-10 Triple Antibiotic Ointment 0.5 g NDC 67777-217
67777-217-072022-11-171180 Triple Antibiotic Ointment 0.5 g NDC 67777-217-05, 1182 Triple Antibiotic Ointment 0.9 g NDC 67777-217-07 1184 Triple Antibiotic Ointment 14.17 g NDC 67777-217-02, 1185 Triple Antibiotic Ointment 28.35 g NDC 67777-217-01 1180UB-10 Triple Antibiotic Ointment 0.5 g NDC 67777-217
67777-217-072022-11-171180 Triple Antibiotic Ointment 0.5 g NDC 67777-217-05, 1182 Triple Antibiotic Ointment 0.9 g NDC 67777-217-07 1184 Triple Antibiotic Ointment 14.17 g NDC 67777-217-02, 1185 Triple Antibiotic Ointment 28.35 g NDC 67777-217-01 1180UB-10 Triple Antibiotic Ointment 0.5 g NDC 67777-217
67777-217-012022-07-291180 Triple Antibiotic Ointment 0.5 g NDC 67777-217-05, 1182 Triple Antibiotic Ointment 0.9 g NDC 67777-217-07 1184 Triple Antibiotic Ointment 14.17 g NDC 67777-217-02, 1185 Triple Antibiotic Ointment 28.35 g NDC 67777-217-01 1180UB-10 Triple Antibiotic Ointment 0.5 g NDC 67777-217
67777-217-012022-07-291180 Triple Antibiotic Ointment 0.5 g NDC 67777-217-05, 1182 Triple Antibiotic Ointment 0.9 g NDC 67777-217-07 1184 Triple Antibiotic Ointment 14.17 g NDC 67777-217-02, 1185 Triple Antibiotic Ointment 28.35 g NDC 67777-217-01 1180UB-10 Triple Antibiotic Ointment 0.5 g NDC 67777-217
67777-217-022022-07-291180 Triple Antibiotic Ointment 0.5 g NDC 67777-217-05, 1182 Triple Antibiotic Ointment 0.9 g NDC 67777-217-07 1184 Triple Antibiotic Ointment 14.17 g NDC 67777-217-02, 1185 Triple Antibiotic Ointment 28.35 g NDC 67777-217-01 1180UB-10 Triple Antibiotic Ointment 0.5 g NDC 67777-217
67777-217-022022-07-291180 Triple Antibiotic Ointment 0.5 g NDC 67777-217-05, 1182 Triple Antibiotic Ointment 0.9 g NDC 67777-217-07 1184 Triple Antibiotic Ointment 14.17 g NDC 67777-217-02, 1185 Triple Antibiotic Ointment 28.35 g NDC 67777-217-01 1180UB-10 Triple Antibiotic Ointment 0.5 g NDC 67777-217
67777-217-052022-07-291180 Triple Antibiotic Ointment 0.5 g NDC 67777-217-05, 1182 Triple Antibiotic Ointment 0.9 g NDC 67777-217-07 1184 Triple Antibiotic Ointment 14.17 g NDC 67777-217-02, 1185 Triple Antibiotic Ointment 28.35 g NDC 67777-217-01 1180UB-10 Triple Antibiotic Ointment 0.5 g NDC 67777-217
67777-217-052022-07-291180 Triple Antibiotic Ointment 0.5 g NDC 67777-217-05, 1182 Triple Antibiotic Ointment 0.9 g NDC 67777-217-07 1184 Triple Antibiotic Ointment 14.17 g NDC 67777-217-02, 1185 Triple Antibiotic Ointment 28.35 g NDC 67777-217-01 1180UB-10 Triple Antibiotic Ointment 0.5 g NDC 67777-217
67777-217-072022-07-291180 Triple Antibiotic Ointment 0.5 g NDC 67777-217-05, 1182 Triple Antibiotic Ointment 0.9 g NDC 67777-217-07 1184 Triple Antibiotic Ointment 14.17 g NDC 67777-217-02, 1185 Triple Antibiotic Ointment 28.35 g NDC 67777-217-01 1180UB-10 Triple Antibiotic Ointment 0.5 g NDC 67777-217
67777-217-072022-07-291180 Triple Antibiotic Ointment 0.5 g NDC 67777-217-05, 1182 Triple Antibiotic Ointment 0.9 g NDC 67777-217-07 1184 Triple Antibiotic Ointment 14.17 g NDC 67777-217-02, 1185 Triple Antibiotic Ointment 28.35 g NDC 67777-217-01 1180UB-10 Triple Antibiotic Ointment 0.5 g NDC 67777-217

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-217-01bacitracin zinc, neomycin sulfate and polymyxin b sulfate28.35 g in 1 TUBEOINTMENT28.3515
67777-217-02bacitracin zinc, neomycin sulfate and polymyxin b sulfate14.17 g in 1 TUBEOINTMENT14.1715
67777-217-04bacitracin zinc, neomycin sulfate and polymyxin b sulfate10 in 1 BOXOINTMENT1015
67777-217-04bacitracin zinc, neomycin sulfate and polymyxin b sulfate0.5 g in 1 PACKETOINTMENT0.515
67777-217-05bacitracin zinc, neomycin sulfate and polymyxin b sulfate0.5 g in 1 PACKETOINTMENT0.515
67777-217-07bacitracin zinc, neomycin sulfate and polymyxin b sulfate0.9 g in 1 PACKETOINTMENT0.915
67777-217-08bacitracin zinc, neomycin sulfate and polymyxin b sulfate100 in 1 CASEOINTMENT10015
67777-217-10bacitracin zinc, neomycin sulfate and polymyxin b sulfate1 in 1 BOXOINTMENT115
67777-217-11bacitracin zinc, neomycin sulfate and polymyxin b sulfate72 in 1 CASEOINTMENT7215
67777-217-12bacitracin zinc, neomycin sulfate and polymyxin b sulfate1 in 1 BOXOINTMENT115
67777-217-13bacitracin zinc, neomycin sulfate and polymyxin b sulfate72 in 1 CASEOINTMENT7215
67777-217-14bacitracin zinc, neomycin sulfate and polymyxin b sulfate144 in 1 BOXOINTMENT14415
67777-217-15bacitracin zinc, neomycin sulfate and polymyxin b sulfate12 in 1 CASEOINTMENT1215
67777-217-16bacitracin zinc, neomycin sulfate and polymyxin b sulfate144 in 1 BOXOINTMENT14415
67777-217-17bacitracin zinc, neomycin sulfate and polymyxin b sulfate12 in 1 CASEOINTMENT1215

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-217-01GM - Gram67777-217fb4089b2-1bd6-405e-beef-7eb53214d41012022-06-06
67777-217-02GM - Gram67777-21789c0706a-0ea1-4e96-a1cd-e51a0d4d024112022-06-06
67777-217-05EA - Each67777-2172a3db4fc-b8ba-47cc-9137-8dd313f5c7aa12017-07-07
67777-217-07EA - Each67777-2172ded4ce0-f0d6-4483-a218-951e2356f53112022-06-06
67777-217-10GM - Gram67777-217c31fc000-6c1f-404f-98db-1272755a3fe112023-01-09
67777-217-11GM - Gram67777-217b546f392-c8ce-4344-bcfc-4757ee7bd76112023-01-09
67777-217-12GM - Gram67777-217e571d5a7-2478-44a2-9b2f-2218f1fba4a412023-01-09
67777-217-13GM - Gram67777-217dd9a9c3b-ec79-4d19-8fdd-b9d0f7619fba12023-01-09
67777-217-14EA - Each67777-217373936ff-a1bc-485b-865d-4d3554867cf512023-01-09
67777-217-15EA - Each67777-217c4d88eeb-6571-435c-ab4f-ec99eb9abe1412023-01-09
67777-217-16EA - Each67777-21717674551-4a49-4dc0-bbf2-98ae2799413612023-01-09
67777-217-17EA - Each67777-217031cc35c-225c-461d-a26c-16dd29c9783212023-01-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESBACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [DYNAREX CORPORATION]6
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [DYNAREX CORPORATION]6
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [DYNAREX CORPORATION]6
BACITRACIN ZINCACTIVE MOIETY89Y4M234ESBACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [DYNAREX CORPORATION]6
NEOMYCINACTIVE MOIETYI16QD7X297BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [DYNAREX CORPORATION]6
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KBACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [DYNAREX CORPORATION]6
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [DYNAREX CORPORATION]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-217BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [DYNAREX CORPORATION]14Current NDC, Legacy NDC, 15 package rows20240124_96d06e4c-c9e7-446f-8b2d-5d030e51d3d3.zip
67777-217SX1 MEDICATED POST-OPERATIVE SYSTEM (LIDOCAINE HYDROCHLORIDE) KIT [IT3 MEDICAL LLC]4Current NDC, Legacy NDC20220302_906c715a-c47c-47f7-9ba0-4e990fb82e89.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 22 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Antiseptic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEFRONT PHARMACEUTICAL PLCcb7fdcde-2bd8-4834-ba4e-4d6fd15125992023-10-26WarningsExact identifier
application number: M004
GENUINE FIRST AID AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.23abfe12-5b50-4b49-878e-4fcdb6c341fd2023-10-19WarningsExact identifier
application number: M004
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.f4921508-c32f-426f-a2f0-16c3acbd47132023-10-14WarningsExact identifier
application number: M004
CuadridermaBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEProMex LLC4fa99b96-ab4b-4523-82bc-343dbaf39fb62022-01-25WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN96d06e4c-c9e7-446f-8b2d-5d030e51d3d315
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD96d06e4c-c9e7-446f-8b2d-5d030e51d3d315
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY96d06e4c-c9e7-446f-8b2d-5d030e51d3d315
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN906c715a-c47c-47f7-9ba0-4e990fb82e894
1011852lidocaine HCl 2 % Topical GelPSN906c715a-c47c-47f7-9ba0-4e990fb82e894
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD906c715a-c47c-47f7-9ba0-4e990fb82e894
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD906c715a-c47c-47f7-9ba0-4e990fb82e894
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY906c715a-c47c-47f7-9ba0-4e990fb82e894
1011852lidocaine hydrochloride 2 % Topical JellySY906c715a-c47c-47f7-9ba0-4e990fb82e894
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN3622b293-f4bc-af1d-e063-6394a90a1c1b1
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSNb419c71d-b02c-4fc1-aa3e-838bf86d6ea21
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD3622b293-f4bc-af1d-e063-6394a90a1c1b1
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDb419c71d-b02c-4fc1-aa3e-838bf86d6ea21
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY3622b293-f4bc-af1d-e063-6394a90a1c1b1
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYb419c71d-b02c-4fc1-aa3e-838bf86d6ea21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-217-016777702170128.35 g in 1 TUBE (67777-217-01) 28.35 g2016-04-180000-00-00NoNoCurrent
67777-217-026777702170214.17 g in 1 TUBE (67777-217-02) 14.17 g2016-04-180000-00-00NoNoCurrent
67777-217-046777702170410 in 1 BOXHistorical
67777-217-0567777021705.5 g in 1 PACKET (67777-217-05) 2016-04-180000-00-00NoNoCurrent
67777-217-0767777021707.9 g in 1 PACKET (67777-217-07) 2016-04-180000-00-00NoNoCurrent
67777-217-0867777021708100 BOX in 1 CASE (67777-217-08) / 10 PACKET in 1 BOX (67777-217-04) / .5 g in 1 PACKET100 box2009-12-01NoNoCurrent
67777-217-10677770217101 in 1 BOXHistorical
67777-217-116777702171172 BOX in 1 CASE (67777-217-11) / 1 TUBE in 1 BOX (67777-217-10) / 28.35 g in 1 TUBE (67777-217-01) 72 box2009-12-010000-00-00NoNoCurrent
67777-217-12677770217121 in 1 BOXHistorical
67777-217-136777702171372 BOX in 1 CASE (67777-217-13) / 1 TUBE in 1 BOX (67777-217-12) / 14.17 g in 1 TUBE (67777-217-02) 72 box2009-12-010000-00-00NoNoCurrent
67777-217-1467777021714144 in 1 BOXHistorical
67777-217-156777702171512 BOX in 1 CASE (67777-217-15) / 144 PACKET in 1 BOX (67777-217-14) / .9 g in 1 PACKET (67777-217-07) 12 box2009-12-010000-00-00NoNoCurrent
67777-217-1667777021716144 in 1 BOXHistorical
67777-217-176777702171712 BOX in 1 CASE (67777-217-17) / 144 PACKET in 1 BOX (67777-217-16) / .5 g in 1 PACKET (67777-217-05) 12 box2009-12-010000-00-00NoNoCurrent