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_38cfd292-4dae-2caf-e063-6394a90a0527
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
bacitracin zinc, neomycin sulfate and polymyxin b sulfate
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4
Rxcui204602

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67777-217-012022-11-17C16284748780-1e4f33bdf-a790-d8a0-e053-dadaa90a6e4e1180 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
67777-217-022022-11-17C16284748780-1e4f33bdf-a790-d8a0-e053-dadaa90a6e4e1180 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
67777-217-052022-11-17C16284748780-1e4f33bdf-a790-d8a0-e053-dadaa90a6e4e1180 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
67777-217-072022-11-17C16284748780-1e4f33bdf-a790-d8a0-e053-dadaa90a6e4e1180 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
67777-217-012022-07-29C16284748780-1e4f33bdf-a790-d8a0-e053-dadaa90a6e4e1180 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
67777-217-022022-07-29C16284748780-1e4f33bdf-a790-d8a0-e053-dadaa90a6e4e1180 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
67777-217-052022-07-29C16284748780-1e4f33bdf-a790-d8a0-e053-dadaa90a6e4e1180 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
67777-217-072022-07-29C16284748780-1e4f33bdf-a790-d8a0-e053-dadaa90a6e4e1180 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

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 box2009-12-01NoNoHistorical
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