FDA.reportPublic FDA data

Triple Antibiotic Ointment, Lil Drug Store

Product NDC
66715-9631
11-digit product format
667159631
Labeler code
66715
Product ID
66715-9631_0d98477b-aa34-ebb7-e063-6294a90a597f
Type
HUMAN OTC DRUG
Nonproprietary name
Triple Antibiotic
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Lil' Drug Store products, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-28
Substance
NEOMYCIN SULFATE; BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
3.5; 400; 5000 mg/g; [iU]/g; [iU]/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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Triple Antibiotic Ointment, Lil Drug Store
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE3.5 mg/g
BACITRACIN ZINC400 [iU]/g
POLYMYXIN B SULFATE5000 [iU]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19371312D4Internal UNII lookup
89Y4M234ESInternal UNII lookup
057Y626693Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204602Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0d98477b-aa33-ebb7-e063-6294a90a597fAvailable on FDA.report

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
66715-9631-0Triple Antibiotic Ointment, Lil Drug Store1 in 1 CARTONOINTMENT11
66715-9631-0Triple Antibiotic Ointment, Lil Drug Store14.2 g in 1 TUBEOINTMENT14.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9631TRIPLE ANTIBIOTIC OINTMENT, LIL DRUG STORE (TRIPLE ANTIBIOTIC) OINTMENT TRIPLE ANTIBIOTIC OINTMENT, CIRCLE K (TRIPLE ANTIBIOTIC) OINTMENT [LIL' DRUG STORE PRODUCTS, INC.]1Current NDC, 2 package rows20240104_0d98477b-aa33-ebb7-e063-6294a90a597f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 22 of 22 · 422 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.f4921508-c32f-426f-a2f0-16c3acbd47132023-10-14WarningsExact identifier
application number: M004
CuadridermaBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEProMex LLC4fa99b96-ab4b-4523-82bc-343dbaf39fb62022-01-25WarningsExact identifier
application number: M004

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 OintmentPSN0d98477b-aa33-ebb7-e063-6294a90a597f1
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD0d98477b-aa33-ebb7-e063-6294a90a597f1
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY0d98477b-aa33-ebb7-e063-6294a90a597f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66715-9631-0667159631001 TUBE in 1 CARTON (66715-9631-0) / 14.2 g in 1 TUBE1 tube2023-12-28NoNoCurrent