triple antibiotic

Generic: bacitracin zinc neomycin sulfate polymyxin b sulfate pramoxine hcl

Labeler: encube ethicals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name triple antibiotic
Generic Name bacitracin zinc neomycin sulfate polymyxin b sulfate pramoxine hcl
Labeler encube ethicals, inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin zinc 500 [USP'U]/g, neomycin sulfate 3.5 mg/g, polymyxin b sulfate 10000 [USP'U]/g, pramoxine hydrochloride 10 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-101
Product ID 21922-101_e439b001-c222-4bcd-b4cf-0bbfd652da5e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2025-03-06

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs] decreased cell wall synthesis & repair [pe] polymyxin-class antibacterial [epc] polymyxins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922101
Hyphenated Format 21922-101

Supplemental Identifiers

RxCUI
1359350
UPC
0321922101058
UNII
89Y4M234ES 057Y626693 19371312D4 88AYB867L5

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name triple antibiotic (source: ndc)
Generic Name bacitracin zinc neomycin sulfate polymyxin b sulfate pramoxine hcl (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 500 [USP'U]/g
  • 3.5 mg/g
  • 10000 [USP'U]/g
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-101-04) / 14 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-101-05) / 28 g in 1 TUBE
source: ndc

Packages (2)

21922-101-04 1 TUBE in 1 CARTON (21922-101-04) / 14 g in 1 TUBE 21922-101-05 1 TUBE in 1 CARTON (21922-101-05) / 28 g in 1 TUBE

Ingredients (4)

bacitracin zinc (500 [USP'U]/g) neomycin sulfate (3.5 mg/g) polymyxin b sulfate (10000 [USP'U]/g) pramoxine hydrochloride (10 mg/g)

Linked Drug Pages (1)

TRIPLE ANTIBIOTIC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "e439b001-c222-4bcd-b4cf-0bbfd652da5e", "openfda": {"upc": ["0321922101058"], "unii": ["89Y4M234ES", "057Y626693", "19371312D4", "88AYB867L5"], "rxcui": ["1359350"], "spl_set_id": ["dfea6b2e-cd76-439d-a3da-64e2d8717163"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-101-04)  / 14 g in 1 TUBE", "package_ndc": "21922-101-04", "marketing_start_date": "20250306"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-101-05)  / 28 g in 1 TUBE", "package_ndc": "21922-101-05", "marketing_start_date": "20250306"}], "brand_name": "TRIPLE ANTIBIOTIC", "product_id": "21922-101_e439b001-c222-4bcd-b4cf-0bbfd652da5e", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "21922-101", "generic_name": "Bacitracin zinc Neomycin sulfate Polymyxin B sulfate Pramoxine Hcl", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TRIPLE ANTIBIOTIC", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "500 [USP'U]/g"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250306", "listing_expiration_date": "20261231"}