FDA.reportPublic FDA data

Signature Care Triple Antibiotic

Product NDC
21130-409
11-digit product format
211300409
Labeler code
21130
Product ID
21130-409_083b9108-bd39-4e41-b718-ae7d5240dbb4
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin, polymyxin B
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Safeway
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-10-14
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
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
Signature Care Triple Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

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

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204602Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
044aff98-f398-40f5-8c18-2751b4ab4384Available 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
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
21130-409-58Signature Care Triple Antibiotic1 in 1 CARTONOINTMENT15
21130-409-58Signature Care Triple Antibiotic14 g in 1 TUBEOINTMENT145
21130-409-64Signature Care Triple Antibiotic28 g in 1 TUBEOINTMENT285
21130-409-64Signature Care Triple Antibiotic1 in 1 CARTONOINTMENT15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESSIGNATURE CARE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [SAFEWAY]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693SIGNATURE CARE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [SAFEWAY]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4SIGNATURE CARE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [SAFEWAY]1
BACITRACINACTIVE MOIETY58H6RWO52ISIGNATURE CARE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [SAFEWAY]1
NEOMYCINACTIVE MOIETYI16QD7X297SIGNATURE CARE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [SAFEWAY]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KSIGNATURE CARE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [SAFEWAY]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SIGNATURE CARE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [SAFEWAY]1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRSIGNATURE CARE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [SAFEWAY]1
COTTONSEED OILINACTIVE INGREDIENTH3E878020NSIGNATURE CARE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [SAFEWAY]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1ESIGNATURE CARE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [SAFEWAY]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USIGNATURE CARE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [SAFEWAY]1
SODIUM PYRUVATEINACTIVE INGREDIENTPOD38AIF08SIGNATURE CARE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [SAFEWAY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-409SIGNATURE CARE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [SAFEWAY]5Current NDC, Legacy NDC, 4 package rows20240920_044aff98-f398-40f5-8c18-2751b4ab4384.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 13 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Balma Septic Antiseptic Hand WashBENZALKONIUM CHLORIDERochester Midland Corporation1b8e0a27-dcdd-4d07-b0f2-55cf74a9b5282025-01-10WarningsExact identifier
application number: M004
LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380CHLOROXYLENOLABC Compounding Co., Inc.efa3938f-64de-77ba-e053-2a95a90ac8402025-01-10WarningsExact identifier
application number: M004
BacitracinBACITRACINA-S Medication Solutions64aa660d-2d69-48e8-bd0d-4876815d89ff2025-01-08WarningsExact identifier
application number: M004
BacitracinBACITRACINWater-Jel Technologies412928a1-3708-4fa8-99c5-aaa2b079cf6e2025-01-06WarningsExact identifier
application number: M004
AVON HeXashield Triple Antibiotic with Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLTai Guk Pharm. Co., Ltd.8e0cb861-d8aa-1f71-e053-2a95a90aaa882025-01-01WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA LLC087694c2-4b1b-e293-e063-6294a90a961f2024-12-31WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETRIFECTA PHARMACEUTICALS USA LLC0c017b10-29b6-e30f-e063-6294a90a8a3c2024-12-31WarningsExact identifier
application number: M004
Triple Antibiotic and Pain ReliefBACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC0bf08cf6-be3f-f9aa-e063-6294a90a43932024-12-31WarningsExact identifier
application number: M004
Single Antibiotic with BacitracinBACITRACIN ZINCRandob Labs Ltd.2a807f1b-986f-a9ea-e063-6394a90aed252024-12-30WarningsExact identifier
application number: M004
TripleantibioticapainscaritchFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCLTrifecta Pharmaceutical USA LLC935106c6-8a9e-07fa-e053-2a95a90a24842024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.TRIFECTA PHARMACEUTICALS USA LLC00c52a31-9bfa-a8bf-e063-6294a90ac4d72024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETrifecta Pharmaceuticals Usa Llcd04b397c-1608-4fd9-be28-ef7285d6a9962024-12-20WarningsExact identifier
application number: M004
TripleantibioticointmentandpainreliefFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC91575333-5268-5d8f-e053-2a95a90a7a892024-12-20WarningsExact identifier
application number: M004
Premier Value Max Strength Antibiotic plus pain reliefPREMIER VALUE NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLPharmacy Value Alliance LLC9767821e-054b-3bd3-e053-2a95a90a4b0e2024-12-20WarningsExact identifier
application number: M004
Premier Value Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPremier Value Alliance LLC.ab843664-a1e0-6716-e053-2995a90a20632024-12-20WarningsExact identifier
application number: M004
Premier Value Bacitracin ZincBACITRACIN ZINCPharmacy Value Alliance LLC99d789be-aa85-0917-e053-2a95a90acd132024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPremier Value Alliance LLC.ab863d90-1a8f-3c1f-e053-2a95a90aa0a72024-12-20WarningsExact identifier
application number: M004
Family Wellness First Aid AntibioticFAMILY WELLNESS BACITRACIN ZINC, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA, LLC9157681a-3ed1-096e-e053-2a95a90a05e32024-12-18WarningsExact identifier
application number: M004
Family Wellness OriginalFAMILY WELLNESS BACITRACIN, NEOMYCIN, POLYMYXIN BTrifecta Pharmaceuticals USA LLC.915759af-0d4f-6a87-e053-2a95a90acbd62024-12-18WarningsExact identifier
application number: M004
Family Wellness Pain Scar ItchBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLTrifecta Pharmaceutical USA LLC9e507ec5-310d-3a21-e053-2a95a90a15a62024-12-18WarningsExact 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 OintmentPSN044aff98-f398-40f5-8c18-2751b4ab43845
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD044aff98-f398-40f5-8c18-2751b4ab43845
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY044aff98-f398-40f5-8c18-2751b4ab43845

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-409-58211300409581 TUBE in 1 CARTON (21130-409-58) / 14 g in 1 TUBE1 tube2015-11-130000-00-00NoNoCurrent
21130-409-64211300409641 TUBE in 1 CARTON (21130-409-64) / 28 g in 1 TUBE1 tube2015-10-140000-00-00NoNoCurrent