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

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 Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4
Rxcui204602

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

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