FDA.reportPublic FDA data

sunmark

Product NDC
49348-600
11-digit product format
493480600
Labeler code
49348
Product ID
49348-600_39fd0345-f7e8-70ae-e063-6294a90a45c3
Type
HUMAN OTC DRUG
Nonproprietary name
polymyxin B sulfate, bacitracin zinc, neomycin sulfate, and pramoxine hydrochloride
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Strategic Sourcing Services LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-03-31
Marketing end
2027-08-31
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
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
sunmark
Brand name suffix
triple antibiotic plus pain relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [iU]/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup
057Y626693Internal UNII lookup
19371312D4Internal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1359350Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
941a6a71-e898-4af3-989a-6d3aa3224338Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-600-72sunmarktriple antibiotic plus pain relief1 in 1 CARTONOINTMENT14
49348-600-72sunmarktriple antibiotic plus pain relief28.4 g in 1 TUBEOINTMENT28.44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-600-72GM - Gram49348-6001ee9eb64-810b-4e1e-b8f3-aaa352812cd412013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESSUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON]1
BACITRACINACTIVE MOIETY58H6RWO52ISUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON]1
NEOMYCINACTIVE MOIETYI16QD7X297SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KSUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON]1
PRAMOXINEACTIVE MOIETY068X84E056SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-600SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [STRATEGIC SOURCING SERVICES LLC]3Current NDC, Legacy NDC, 2 package rows20241006_941a6a71-e898-4af3-989a-6d3aa3224338.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
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSN941a6a71-e898-4af3-989a-6d3aa32243384
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD941a6a71-e898-4af3-989a-6d3aa32243384
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY941a6a71-e898-4af3-989a-6d3aa32243384
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSN01131ba6-6d5b-4710-bec3-ba1769c08c792
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD01131ba6-6d5b-4710-bec3-ba1769c08c792
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY01131ba6-6d5b-4710-bec3-ba1769c08c792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-600-72493480600721 TUBE in 1 CARTON (49348-600-72) / 28.4 g in 1 TUBE1 tube2013-02-132027-08-31NoNoCurrent