FDA.reportPublic FDA data

MEDI-FIRST

Product NDC
71927-017
11-digit product format
719270017
Labeler code
71927
Product ID
71927-017_3ded7523-0f2e-82da-e063-6394a90a8f29
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Orazen Inc
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-03
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; .0035; 5000 [USP'U]/g; g/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
MEDI-FIRST
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [USP'U]/g
NEOMYCIN SULFATE.0035 g/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
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71927-017-022025-09-03C16284748780-12cef2736-9e69-d83d-e063-dadaa90ab31f71927-017-01, -02, MEDI-FIRST Triple Antibiotic Ointment
71927-017-032025-09-03C16284748780-12cef2736-622e-d83d-e063-dadaa90ab31f71927-017-01, -03, MEDI-FIRST Triple Antibiotic Ointment
71927-017-042025-09-03C16284748780-12cef2736-7150-d83d-e063-dadaa90ab31f71729-017-01, -04 MEDI-FIRST PLUS Triple Antibiotic Ointment
71927-017-022025-01-30C16284748780-12cef2736-9e69-d83d-e063-dadaa90ab31f71927-017-01, -02, MEDI-FIRST Triple Antibiotic Ointment
71927-017-032025-01-30C16284748780-12cef2736-622e-d83d-e063-dadaa90ab31f71927-017-01, -03, MEDI-FIRST Triple Antibiotic Ointment
71927-017-042025-01-30C16284748780-12cef2736-7150-d83d-e063-dadaa90ab31f71729-017-01, -04 MEDI-FIRST PLUS Triple Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71927-017-01MEDI-FIRST0.5 g in 1 POUCHOINTMENT0.52
71927-017-01MEDI-FIRST0.5 g in 1 POUCHOINTMENT0.52
71927-017-01MEDI-FIRST0.5 g in 1 POUCHOINTMENT0.52
71927-017-02MEDI-FIRST25 in 1 BOXOINTMENT252
71927-017-03MEDI-FIRST144 in 1 BOXOINTMENT1442
71927-017-04MEDI-FIRST25 in 1 BOXOINTMENT252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71927-017MEDI-FIRST (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ORAZEN INC]1Current NDC, 2 package rows20230219_f4e4854a-ee01-df72-e053-2995a90aa8ea.zip
71927-017MEDI-FIRST (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ORAZEN INC]1Current NDC, 2 package rows20230219_f4e4d0a4-b90c-99b0-e053-2995a90ab423.zip
71927-017MEDI-FIRST (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ORAZEN INC]1Current NDC, 2 package rows20230219_f4e42c5c-e080-4efb-e053-2a95a90af52e.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 OintmentPSNf4e42c5c-e080-4efb-e053-2a95a90af52e2
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSNf4e4854a-ee01-df72-e053-2995a90aa8ea2
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSNf4e4d0a4-b90c-99b0-e053-2995a90ab4232
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDf4e42c5c-e080-4efb-e053-2a95a90af52e2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDf4e4854a-ee01-df72-e053-2995a90aa8ea2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDf4e4d0a4-b90c-99b0-e053-2995a90ab4232
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYf4e42c5c-e080-4efb-e053-2a95a90af52e2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYf4e4854a-ee01-df72-e053-2995a90aa8ea2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYf4e4d0a4-b90c-99b0-e053-2995a90ab4232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71927-017-01719270017010.5 g in 1 POUCH0.5 gHistorical
71927-017-027192700170225 POUCH in 1 BOX (71927-017-02) / .5 g in 1 POUCH (71927-017-01) 25 pouch2025-08-29NoNoHistorical
71927-017-0371927001703144 POUCH in 1 BOX (71927-017-03) / .5 g in 1 POUCH (71927-017-01) 144 pouch2025-09-03NoNoHistorical
71927-017-047192700170425 POUCH in 1 BOX (71927-017-04) / .5 g in 1 POUCH (71927-017-01) 25 pouch2025-09-03NoNoHistorical