american safety and first aid triple antibiotic

Generic: bacitracin zinc, neomycin sulfate, polymyxin b sulfate

Labeler: orazen inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name american safety and first aid triple antibiotic
Generic Name bacitracin zinc, neomycin sulfate, polymyxin b sulfate
Labeler orazen inc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin zinc 400 [USP'U]/g, neomycin sulfate .0035 g/g, polymyxin b sulfate 5000 [USP'U]/g

Manufacturer
Orazen Inc

Identifiers & Regulatory

Product NDC 71927-016
Product ID 71927-016_0effc169-28e6-9eb0-e063-6394a90a432a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2022-10-17

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 71927016
Hyphenated Format 71927-016

Supplemental Identifiers

RxCUI
204602
UNII
89Y4M234ES 057Y626693 19371312D4

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 american safety and first aid triple antibiotic (source: ndc)
Generic Name bacitracin zinc, neomycin sulfate, polymyxin b sulfate (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 400 [USP'U]/g
  • .0035 g/g
  • 5000 [USP'U]/g
source: ndc
Packaging
  • 144 POUCH in 1 BOX (71927-016-03) / .5 g in 1 POUCH (71927-016-01)
source: ndc

Packages (1)

71927-016-03 144 POUCH in 1 BOX (71927-016-03) / .5 g in 1 POUCH (71927-016-01)

Ingredients (3)

bacitracin zinc (400 [USP'U]/g) neomycin sulfate (.0035 g/g) polymyxin b sulfate (5000 [USP'U]/g)

Linked Drug Pages (1)

American Safety and First Aid Triple Antibiotic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0effc169-28e6-9eb0-e063-6394a90a432a", "openfda": {"unii": ["89Y4M234ES", "057Y626693", "19371312D4"], "rxcui": ["204602"], "spl_set_id": ["eb0df2da-1688-c477-e053-2995a90a74a2"], "manufacturer_name": ["Orazen Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "144 POUCH in 1 BOX (71927-016-03)  / .5 g in 1 POUCH (71927-016-01)", "package_ndc": "71927-016-03", "marketing_start_date": "20221017"}], "brand_name": "American Safety and First Aid Triple Antibiotic", "product_id": "71927-016_0effc169-28e6-9eb0-e063-6394a90a432a", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "71927-016", "generic_name": "Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate", "labeler_name": "Orazen Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "American Safety and First Aid Triple Antibiotic", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "400 [USP'U]/g"}, {"name": "NEOMYCIN SULFATE", "strength": ".0035 g/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "5000 [USP'U]/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20221017", "listing_expiration_date": "20261231"}