FDA.reportPublic FDA data

DG Health Triple Antibiotic

Product NDC
55910-209
11-digit product format
559100209
Labeler code
55910
Product ID
55910-209_a47d8bb3-ddb4-4a36-a87b-b4bba9a096bf
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin, polymyxin B
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dolgencorp, LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-23
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/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

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
DG Health Triple Antibiotic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [USP'U]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [USP'U]/g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-209-16DG Health Triple Antibiotic2 in 1 CARTONOINTMENT25
55910-209-16DG Health Triple Antibiotic28 g in 1 TUBEOINTMENT285
55910-209-64DG Health Triple Antibiotic28 g in 1 TUBEOINTMENT285
55910-209-64DG Health Triple Antibiotic1 in 1 CARTONOINTMENT15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESDG HEALTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [DOLGENCORP, LLC]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693DG HEALTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [DOLGENCORP, LLC]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4DG HEALTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [DOLGENCORP, LLC]1
BACITRACINACTIVE MOIETY58H6RWO52IDG HEALTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [DOLGENCORP, LLC]1
NEOMYCINACTIVE MOIETYI16QD7X297DG HEALTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [DOLGENCORP, LLC]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KDG HEALTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [DOLGENCORP, LLC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0DG HEALTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [DOLGENCORP, LLC]1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRDG HEALTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [DOLGENCORP, LLC]1
COTTONSEED OILINACTIVE INGREDIENTH3E878020NDG HEALTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [DOLGENCORP, LLC]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EDG HEALTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [DOLGENCORP, LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UDG HEALTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [DOLGENCORP, LLC]1
SODIUM PYRUVATEINACTIVE INGREDIENTPOD38AIF08DG HEALTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [DOLGENCORP, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-209DG HEALTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [DOLGENCORP, LLC]5Current NDC, Legacy NDC, 4 package rows20240920_1694f4ee-1065-4b13-b642-b8437f473541.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 18 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Major Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFATMajor Pharmaceuticalsa6cc3fbc-6302-4033-e053-2a95a90a19f02024-09-11WarningsExact identifier
application number: M004
Leader Triple antibioticBACITRACIN,NEOMYCIN,POLYMXINCardinal Health 110 dba LEADER2175e00a-bf85-3377-e063-6394a90a916f2024-09-06WarningsExact identifier
application number: M004
Members Mark Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BSam's West Inc200f4020-7699-4a9e-8fab-2d3df9e768362024-09-05WarningsExact identifier
application number: M004
Leader Poly BacitracinBACITRACIN ZINC POLYMIXIN B SULFATECardinal Health 110 dba LEADER20d7624f-cafa-25e1-e063-6394a90a44392024-08-29WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BMeijer Distribution Incedcb423e-b5c2-4e26-8f7f-9b9ee575042c2024-08-19WarningsExact identifier
application number: M004
Major ClotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals,Inc.562dfc9f-1897-330a-e054-00144ff8d46c2024-08-14WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWildeman Business Group1f96450a-3bda-1f0a-e063-6294a90a514f2024-08-13WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEProvision Medicalbbf4b99c-9738-4855-82a6-f4e213924ec92024-08-09WarningsExact identifier
application number: M004
Tetracyte Topical Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC4ac5177d-bb67-45e6-adcf-44f0821746bd2024-08-01WarningsExact identifier
application number: M004
BacitracinBACITRACINPadagis Israel Pharmaceuticals Ltdbebbedf6-dd65-47a4-aa3e-ad197b3e05a12024-07-31WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCChain Drug Marketing Association Inc.1cd9ded3-068c-496e-e063-6394a90a6a0b2024-07-09WarningsExact identifier
application number: M004
Anti-Itch with AloeHYDROCORTISONE 1%Chain Drug Marketing Association Inc.1cbea7cd-03a0-1469-e063-6294a90a7cc12024-07-08WarningsExact identifier
application number: M004
astonea First AidBACITRACIN ZINCASTONEA LABS PRIVATE LIMITEDde0b2e06-64bc-78f0-e053-2995a90a39a02024-06-25WarningsExact identifier
application number: M004
Publix Bacitracin ZincBACITRACIN ZINCPUBLIX SUPER MARKETS, INC.51f21123-7826-40c9-b2aa-b202125085e22024-06-17WarningsExact identifier
application number: M004
Publix Triple AntibioticBACITRACIN ZINC 400 U, POLYMXYIN B SULFATE 5,000 U, NEOMYCIN SULFATE 3.5MG/GPUBLIX SUPER MARKETS, INC.871fa43c-a1be-4c15-bbfa-a998a2d89d2e2024-06-17WarningsExact identifier
application number: M004
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMNuCare Pharmaceuticals,Inc.66ff9726-20da-688a-e053-2a91aa0a59ac2024-06-06WarningsExact identifier
application number: M004
QC Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.Chain Drug Marketing Association1a1501a4-75b0-5900-e063-6394a90ad77a2024-06-04WarningsExact identifier
application number: M004
Always Save Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLC1a00df31-a38a-fc82-e063-6394a90abbf32024-06-03WarningsExact identifier
application number: M004
PENTREXCILINA TRIPLE ANTIBIOTIC PLUS PAIN RELIEFBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINEOPMX LLC7c0d3cdf-af50-4a65-a01b-a33510feeb942024-05-17WarningsExact identifier
application number: M004
PENIMIXCINABACITRACIN, NEOMYCIN SULFATE, POLYMIXIN B SULFATE, PRAMOXINE HYDROCHLORIDEOPMX LLC92bcbc02-9683-4117-af2b-6d4687796f1f2024-05-17WarningsExact 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 OintmentPSN1694f4ee-1065-4b13-b642-b8437f4735415
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD1694f4ee-1065-4b13-b642-b8437f4735415
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY1694f4ee-1065-4b13-b642-b8437f4735415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-209-16559100209162 TUBE in 1 CARTON (55910-209-16) / 28 g in 1 TUBE2 tube2016-09-200000-00-00NoNoCurrent
55910-209-64559100209641 TUBE in 1 CARTON (55910-209-64) / 28 g in 1 TUBE1 tube2015-06-230000-00-00NoNoCurrent