FDA.reportPublic FDA data

TRIPLE ANTIBIOTIC

Product NDC
21922-101
11-digit product format
219220101
Labeler code
21922
Product ID
21922-101_e439b001-c222-4bcd-b4cf-0bbfd652da5e
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin zinc Neomycin sulfate Polymyxin B sulfate Pramoxine Hcl
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-06
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/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
TRIPLE ANTIBIOTIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [USP'U]/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4, 88AYB867L5
Rxcui1359350

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21922-101-04TRIPLE ANTIBIOTIC14 g in 1 TUBEOINTMENT142
21922-101-04TRIPLE ANTIBIOTIC1 in 1 CARTONOINTMENT12
21922-101-05TRIPLE ANTIBIOTIC1 in 1 CARTONOINTMENT12
21922-101-05TRIPLE ANTIBIOTIC28 g in 1 TUBEOINTMENT282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-101-05GM - Gram21922-101b2dc1641-bd1f-4026-96de-1145a47f470912025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-101TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE PRAMOXINE HCL) OINTMENT [ENCUBE ETHICALS PRIVATE LIMITED]1Current NDC, 4 package rows20250419_dfea6b2e-cd76-439d-a3da-64e2d8717163.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSNdfea6b2e-cd76-439d-a3da-64e2d87171632
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCDdfea6b2e-cd76-439d-a3da-64e2d87171632
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSYdfea6b2e-cd76-439d-a3da-64e2d87171632

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-101-04219220101041 TUBE in 1 CARTON (21922-101-04) / 14 g in 1 TUBE1 tube2025-03-06NoNoCurrent
21922-101-05219220101051 TUBE in 1 CARTON (21922-101-05) / 28 g in 1 TUBE1 tube2025-03-06NoNoCurrent