FDA.reportPublic FDA data

Antibiotic

Product NDC
72663-560
11-digit product format
726630560
Labeler code
72663
Product ID
72663-560_2cdef8a8-b026-c5cc-e063-6294a90af78d
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate, polymyxin b sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Welly Health PBC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-25
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
6; 3.5; .77 mg/mL; mg/mL; mg/mL
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

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
Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC6 mg/mL
NEOMYCIN SULFATE3.5 mg/mL
POLYMYXIN B SULFATE.77 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup
057Y626693Internal UNII lookup
19371312D4Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9446375d-4bb4-4bb1-bdc2-c18e995bfe26Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72663-560-34Antibiotic0.5 mL in 1 POUCHOINTMENT0.57
72663-560-34Welly First Aid Kit0.5 mL in 1 POUCHOINTMENT5 mL in .53.5 mg in 1mL4
72663-560-12Antibiotic12 in 1 BOXOINTMENT122
72663-560-34Antibiotic0.5 g in 1 POUCHOINTMENT0.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72663-560ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WELLY HEALTH PBC]7Current NDC, Legacy NDC, 1 package rows20250130_9446375d-4bb4-4bb1-bdc2-c18e995bfe26.zip
72663-560ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WELLY HEALTH PBC]2Current NDC, Legacy NDC, 2 package rows20200207_74f12f20-c610-4776-97ba-4c2c6350e102.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 21 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Bacitracin ZincBACITRACIN ZINCCardinal Health 110 dba LEADERa353dce2-8ae5-23aa-e053-2a95a90a89c22024-01-02WarningsExact identifier
application number: M004
Triple AntibioticPOLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATENuCare Pharmaceuticals,Inc.0dfe5f6a-6968-68e6-e063-6294a90ae25b2024-01-02WarningsExact identifier
application number: M004
BacitracinBACITRACINProficient Rx LPe1166948-5d80-44c2-a20d-78be631647d92024-01-01WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEProficient Rx LP949c5b44-ee52-4913-8872-39181d3199982024-01-01WarningsExact identifier
application number: M004
Triple Antibiotic PlusPOLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HCLCosette Pharmaceuticals, Inc.69d911c2-cb89-2241-35f8-c83acfe182492023-12-21WarningsExact identifier
application number: M004
BacitracinBACITRACINCosette Pharmaceuticals, Inc.630e0841-baf2-e9fa-b309-ad1a5f95da3b2023-12-20WarningsExact identifier
application number: M004
Triple AntibioticPOLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATECosette Pharmaceuticals, Inc.39893365-c94f-bc83-67f6-0005d5f2aa242023-12-20WarningsExact identifier
application number: M004
Triple AntibioticPOLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATEProficient Rx LP524d65e7-9dc6-47b0-a924-46a765fa18692023-12-01WarningsExact identifier
application number: M004
ViabeclineTETRACYCLINE HYDROCHLORIDEAccuria, LLC9fd7041a-6c23-4332-90fe-759bb4aea2ae2023-12-01WarningsExact identifier
application number: M004
BacitracinBACITRACINProficient Rx LP65f8fd49-1882-4eac-9c0e-d63968da33d42023-12-01WarningsExact identifier
application number: M004
Genuine First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEGFA Production(Xiamen) Co.,Ltd0aaee474-cf35-8b39-e063-6294a90a815c2023-11-21WarningsExact identifier
application number: M004
Sheffield Bacitracin ZincBACITRACIN ZINCSheffield Pharmaceuticals LLC0f446f48-f55d-4de7-b447-285d7a329c842023-11-20WarningsExact identifier
application number: M004
Sheffield Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDESheffield Pharmaceuticals LLC485a779c-017b-4064-a446-e5073c1bdb072023-11-20WarningsExact identifier
application number: M004
BacitracinBACITRACINBluePoint Laboratoriesb4d8ef06-6269-68f7-e053-2995a90ac8ea2023-11-17WarningsExact identifier
application number: M004
Bacitracin ZincFIRST AID ANTIBIOTICBluePoint Laboratoriesd914abe1-5e14-5673-e053-2a95a90ac91b2023-11-17WarningsExact identifier
application number: M004
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEVERLIT GLOBAL INC.e9157891-fc05-41a1-8a86-761a9ae56f8a2023-11-14WarningsExact identifier
application number: M004
CR-371059 Tolnaftate 1%CR-371059 TOLNAFTATE 1%A-S Medication Solutionsbb4e4612-850c-4863-954d-7ad0500b9c052023-11-01WarningsExact identifier
application number: M004
Isopropyl AlcoholISOPROPYL ALCOHOLA-S Medication Solutionsb44b07a0-91ff-476a-ae0a-080fa01917772023-10-31WarningsExact identifier
application number: M004
Family wellnessBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEFRONT PHARMACEUTICAL PLCbd3b8146-6271-488d-bf79-0bb659123b312023-10-27WarningsExact identifier
application number: M004
Family WellnessBACITRACIN ZINCFRONT PHARMACEUTICAL PLCdfc148c1-d1bb-4230-b8cf-9457b99d4e8a2023-10-27WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616762ethanol 66.5 % Topical GelPSN55f717e6-764e-444c-aa70-517174b7553f6
616762ethanol 0.665 ML/ML Topical GelSCD55f717e6-764e-444c-aa70-517174b7553f6
616762ethanol 66.5 % Topical GelSY55f717e6-764e-444c-aa70-517174b7553f6
616762ethanol 66.5 % Topical GelPSN5ef18c81-fa81-4ead-bb13-a14060946cf05
616762ethanol 0.665 ML/ML Topical GelSCD5ef18c81-fa81-4ead-bb13-a14060946cf05
616762ethanol 66.5 % Topical GelSY5ef18c81-fa81-4ead-bb13-a14060946cf05
616762ethanol 66.5 % Topical GelPSNb049bc90-66a9-48a6-b69e-7e890c91d7dd4
310965ibuprofen 200 MG Oral TabletPSN11432329-12a1-4d73-b038-912175a49d094
616762ethanol 0.665 ML/ML Topical GelSCDb049bc90-66a9-48a6-b69e-7e890c91d7dd4
310965ibuprofen 200 MG Oral TabletSCD11432329-12a1-4d73-b038-912175a49d094
616762ethanol 66.5 % Topical GelSYb049bc90-66a9-48a6-b69e-7e890c91d7dd4
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY11432329-12a1-4d73-b038-912175a49d094
616762ethanol 66.5 % Topical GelPSNd4186754-ed6a-4c59-b841-8f4d7b880cd13
310965ibuprofen 200 MG Oral TabletPSN28349109-649b-40a7-bfe7-c910061bc30b3
616762ethanol 0.665 ML/ML Topical GelSCDd4186754-ed6a-4c59-b841-8f4d7b880cd13
310965ibuprofen 200 MG Oral TabletSCD28349109-649b-40a7-bfe7-c910061bc30b3
616762ethanol 66.5 % Topical GelSYd4186754-ed6a-4c59-b841-8f4d7b880cd13
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY28349109-649b-40a7-bfe7-c910061bc30b3
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN74f12f20-c610-4776-97ba-4c2c6350e1022
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD74f12f20-c610-4776-97ba-4c2c6350e1022
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY74f12f20-c610-4776-97ba-4c2c6350e1022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72663-560-127266305601212 in 1 BOXHistorical
72663-560-3472663056034.5 mL in 1 POUCH (72663-560-34) 2019-02-250000-00-00NoNoCurrent