FDA.reportPublic FDA data

CareALL Triple Antibiotic

Product NDC
51824-052
11-digit product format
518240052
Labeler code
51824
Product ID
51824-052_44ec1640-b3c7-be5b-e063-6294a90afde4
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
New World Imports, Inc
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-03-15
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 5; 5000 [USP'U]/g; mg/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
CareALL Triple Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [USP'U]/g
NEOMYCIN SULFATE5 mg/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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51824-052-01CareALL Triple Antibiotic28 g in 1 TUBEOINTMENT287
51824-052-09CareALL Triple Antibiotic0.9 g in 1 PACKETOINTMENT0.97
51824-052-14CareALL Triple Antibiotic144 in 1 CARTONOINTMENT1447
51824-052-25CareALL Triple Antibiotic25 in 1 CARTONOINTMENT257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-052-01GM - Gram51824-05244821f27-eb75-4ccd-9c4d-a3ac9a1e341412020-03-10
51824-052-14EA - Each51824-0529fcb71d9-a551-4eec-9e82-4e91fc6603cd12022-11-07
51824-052-25EA - Each51824-052b477e325-f04f-4ef0-bb58-079f8cd9f9a712023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-052CAREALL TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [NEW WORLD IMPORTS, INC]6Current NDC, Legacy NDC, 4 package rows20231013_9c2d417e-6fec-42f4-9f0c-2ec79de9342d.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 OintmentPSN9c2d417e-6fec-42f4-9f0c-2ec79de9342d7
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD9c2d417e-6fec-42f4-9f0c-2ec79de9342d7
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY9c2d417e-6fec-42f4-9f0c-2ec79de9342d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51824-052-015182400520128 g in 1 TUBE (51824-052-01) 28 g2016-03-150000-00-00NoNoCurrent
51824-052-0951824005209.9 g in 1 PACKET (51824-052-09) 2016-03-150000-00-00NoNoCurrent
51824-052-1451824005214144 PACKET in 1 CARTON (51824-052-14) / .9 g in 1 PACKET (51824-052-09) 144 packet2022-05-010000-00-00NoNoCurrent
51824-052-255182400522525 PACKET in 1 CARTON (51824-052-25) / .9 g in 1 PACKET (51824-052-09) 25 packet2022-05-010000-00-00NoNoCurrent