FDA.reportPublic FDA data

EQUATE Triple Antibiotic

Product NDC
49035-067
11-digit product format
490350067
Labeler code
49035
Product ID
49035-067_c360fe96-446a-4872-a604-d9a3c813d3ac
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Wal-Mart Stores Inc
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-08-31
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [iU]/g; mg/g; [iU]/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
EQUATE Triple Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [iU]/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
49035-067-16EQUATE Triple Antibiotic2 in 1 CARTONOINTMENT212
49035-067-16EQUATE Triple Antibiotic28 g in 1 TUBEOINTMENT2812
49035-067-64EQUATE Triple Antibiotic28 g in 1 TUBEOINTMENT2812
49035-067-64EQUATE Triple Antibiotic1 in 1 CARTONOINTMENT112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-067-16GM - Gram49035-06712f9aeb9-d252-418a-a33c-7ee3b7371e2012019-01-24
49035-067-64GM - Gram49035-067df4aa58c-8cbf-4a67-a55e-668a992fc4bd12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WAL-MART STORES, INC.]3
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WAL-MART STORES, INC.]3
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WAL-MART STORES, INC.]3
BACITRACINACTIVE MOIETY58H6RWO52ITRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WAL-MART STORES, INC.]3
NEOMYCINACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WAL-MART STORES, INC.]3
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WAL-MART STORES, INC.]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WAL-MART STORES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-067EQUATE TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [WAL-MART STORES INC]12Current NDC, Legacy NDC, 4 package rows20240919_fa35f446-6a58-4d8c-859e-89cd631a9e8f.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 OintmentPSNfa35f446-6a58-4d8c-859e-89cd631a9e8f12
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDfa35f446-6a58-4d8c-859e-89cd631a9e8f12
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYfa35f446-6a58-4d8c-859e-89cd631a9e8f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-067-16490350067162 TUBE in 1 CARTON (49035-067-16) / 28 g in 1 TUBE2 tube2010-08-310000-00-00NoNoCurrent
49035-067-64490350067641 TUBE in 1 CARTON (49035-067-64) / 28 g in 1 TUBE1 tube2010-08-310000-00-00NoNoCurrent