FDA.reportPublic FDA data

First Aid Antibiotic

Product NDC
0363-0841
11-digit product format
003630841
Labeler code
0363
Product ID
0363-0841_f072c90e-0654-4837-b936-c4bebb5f23f8
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Walgreen Company
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-02-16
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
First Aid 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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
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
0363-0841-58First Aid Antibiotic14 g in 1 TUBEOINTMENT145
0363-0841-58First Aid Antibiotic1 in 1 CARTONOINTMENT15
0363-0841-64First Aid Antibiotic28 g in 1 TUBEOINTMENT285
0363-0841-64First Aid Antibiotic1 in 1 CARTONOINTMENT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0841-58GM - Gram0363-0841a0738563-12c1-4c61-a732-19962498dde412022-06-06
0363-0841-64GM - Gram0363-0841a763b810-c902-49c4-ab4d-8980f852d23f12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0841FIRST AID ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL) OINTMENT [WALGREEN COMPANY]5Current NDC, Legacy NDC, 4 package rows20241108_b982091a-5aa0-4bbc-bb1d-08016f6d0a70.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 OintmentPSNb982091a-5aa0-4bbc-bb1d-08016f6d0a705
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCDb982091a-5aa0-4bbc-bb1d-08016f6d0a705
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSYb982091a-5aa0-4bbc-bb1d-08016f6d0a705

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0841-58003630841581 TUBE in 1 CARTON (0363-0841-58) / 14 g in 1 TUBE1 tube2017-02-160000-00-00NoNoCurrent
0363-0841-64003630841641 TUBE in 1 CARTON (0363-0841-64) > 28 g in 1 TUBE1 tube2017-02-160000-00-00NoNoCurrent