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 6 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Water-Jel Neomycin AntibioticFIRST AID OINTMENTWater-Jel Technologiesabea91a2-4453-406d-a7ed-3ffc19ef521a2025-12-31WarningsExact identifier
application number: M004
Caring Mill Triple Antibiotic and PainPRAMOXINE HYDROCHLORIDE, BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATEFSA Store Inc. (Caring Mills)3c5b6909-6b30-5256-e063-6294a90a90962025-12-29WarningsExact identifier
application number: M004
Caring Mills Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEVeridian Healthcarefbd11419-4513-10d7-e053-6394a90ac82b2025-12-27WarningsExact identifier
application number: M004
Caring Mill Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEVeridian Healthcare8cd0cd64-fe62-4225-8986-5e8641dd6df22025-12-22WarningsExact identifier
application number: M004
PS-2261 Triple Antibiotic, 0.5gPS-2261 TRIPLE ANTIBIOTIC, 0.5GProStat First Aid LLC0072f8de-fc06-d529-e063-6294a90a08db2025-12-15WarningsExact identifier
application number: M004
PS - 2895 Triple Antibiotic , 0.5gPS - 2895 TRIPLE ANTIBIOTIC , 0.5GProstat First Aid LLC0050de33-914b-f76d-e063-6394a90a7fab2025-12-15WarningsExact identifier
application number: M004
Triple AntibioticTRIPLE ANTIBIOTICProStat First Aidf76d7d18-0fa1-d943-e053-6294a90ac20a2025-12-15WarningsExact identifier
application number: M004
Triple AntibioticTRIPLE ANTIBIOTICFront Line Safety0f509f96-a083-37d1-e063-6394a90a622c2025-12-15WarningsExact identifier
application number: M004
ElixirTripleGuard Triple AntibioticBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN BELIXIR HEALTHCARE USA, LLC.43edfb80-4d50-9362-e063-6394a90a21992025-12-13WarningsExact identifier
application number: M004
El Valle Decolorized IodineALCOHOLPharmadel LLCfd7a227b-536c-b3f7-e053-6394a90a41582025-12-04WarningsExact identifier
application number: M004
Vitastem First Aid AntibioticTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC3970ac49-ab0f-4492-ba61-95a12faed5002025-12-02WarningsExact identifier
application number: M004
Thera Plus Original Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEFourstar Group USA, Inc2f916502-4daf-4cb9-a638-f37bb96c80772025-12-02WarningsExact identifier
application number: M004
CAREALL BacitracinBACITRACIN ZINCNew World Imports, Incea16e1de-0100-456b-abe6-d33de78221da2025-12-02WarningsExact identifier
application number: M004
Triple Antibiotic Ointment, Circle KTRIPLE ANTIBIOTIC OINTMENTLil' Drug Store Products, Inc.44e5107e-832a-2ce6-e063-6294a90a711d2025-12-01WarningsExact identifier
application number: M004
Viaderma Care First Aid AntibioticBACITRACIN ZINCVIADERMA DISTRIBUTION INC0f36f396-e479-486c-b047-2760477609e22025-12-01WarningsExact identifier
application number: M004
CareALL Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLNew World Imports, Inc1982b664-e8fd-4030-aa89-f7543e1b487b2025-12-01WarningsExact identifier
application number: M004
CareALL Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENew World Imports, Inc9c2d417e-6fec-42f4-9f0c-2ec79de9342d2025-12-01WarningsExact identifier
application number: M004
BacitracinBACITRACINBryant Ranch Prepack5b0249c0-c196-4d3c-973f-49bd2d3d4a752025-12-01WarningsExact identifier
application number: M004
Neosporin Plus LidocaineBACITRACIN, NEOMYCIN, POLYMYXIN B, LIDOCAINEKenvue Brands LLCe450b6a1-a8da-e5db-e053-2995a90a0ef02025-11-24WarningsExact identifier
application number: M004
ElixirZincoCareZINC OXIDE 20%ELIXIR HEALTHCARE USA, LLC.bac18496-3b76-4faf-abde-968d79b718d82025-11-22WarningsExact 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