FDA.reportPublic FDA data

American Safety and First Aid Triple Antibiotic

Product NDC
71927-016
11-digit product format
719270016
Labeler code
71927
Product ID
71927-016_0effc169-28e6-9eb0-e063-6394a90a432a
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
2022-10-17
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
American Safety and First Aid Triple Antibiotic
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
71927-016-022024-01-30C16284748780-11030e365-457c-111a-e063-dadaa90a10e2American Safety & First Aid Triple Antibiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71927-016-01American Safety and First Aid Triple Antibiotic0.5 g in 1 POUCHOINTMENT0.52
71927-016-03American Safety and First Aid Triple Antibiotic144 in 1 BOXOINTMENT1442
71927-016-01American Safety and First Aid Triple Antibiotic0.5 g in 1 POUCHOINTMENT0.51
71927-016-02American Safety and First Aid Triple Antibiotic25 in 1 BOXOINTMENT251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71927-016AMERICAN SAFETY AND FIRST AID TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ORAZEN INC]2Current NDC, Legacy NDC, 2 package rows20240116_eb0df2da-1688-c477-e053-2995a90a74a2.zip
71927-016AMERICAN SAFETY AND FIRST AID TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ORAZEN INC]1Current NDC, Legacy NDC, 2 package rows20221018_eb0d108f-42bf-3364-e053-2a95a90a4542.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 OintmentPSNeb0df2da-1688-c477-e053-2995a90a74a22
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDeb0df2da-1688-c477-e053-2995a90a74a22
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYeb0df2da-1688-c477-e053-2995a90a74a22
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSNeb0d108f-42bf-3364-e053-2a95a90a45421
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDeb0d108f-42bf-3364-e053-2a95a90a45421
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYeb0d108f-42bf-3364-e053-2a95a90a45421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71927-016-01719270016010.5 g in 1 POUCH0.5 gHistorical
71927-016-027192700160225 POUCH in 1 BOX (71927-016-02) > .5 g in 1 POUCH (71927-016-01) 25 pouch2022-10-170000-00-00NoNoCurrent
71927-016-0371927001603144 POUCH in 1 BOX (71927-016-03) / .5 g in 1 POUCH (71927-016-01) 144 pouch2022-10-170000-00-00NoNoCurrent