FDA.reportPublic FDA data

Cuadriderma

Product NDC
58988-1170
11-digit product format
589881170
Labeler code
58988
Product ID
58988-1170_ea8f2105-b483-4ecb-b1a9-babd58f2e44a
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate, and PRAMOXINE HYDROCHLORIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
ProMex LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-31
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/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
Cuadriderma
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [iU]/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4, 88AYB867L5
Rxcui1359350, 1673566

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58988-1170-12022-01-30C16284748780-1d6a99b39-bb02-a426-e053-dadaa90af4c2Cuadriderma ®
58988-1170-12022-01-28C16284748780-1d6a99b39-bb02-a426-e053-dadaa90af4c2Cuadriderma ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58988-1170-1Cuadriderma1 in 1 CARTONOINTMENT110
58988-1170-1Cuadriderma28.35 g in 1 TUBEOINTMENT28.3510

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESCUADRIDERMA (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [PROMEX LLC]1
Neomycin SulfateACTIVE INGREDIENT057Y626693CUADRIDERMA (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [PROMEX LLC]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4CUADRIDERMA (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [PROMEX LLC]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5CUADRIDERMA (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [PROMEX LLC]1
BacitracinACTIVE MOIETY58H6RWO52ICUADRIDERMA (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [PROMEX LLC]1
NeomycinACTIVE MOIETYI16QD7X297CUADRIDERMA (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [PROMEX LLC]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KCUADRIDERMA (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [PROMEX LLC]1
PRAMOXINEACTIVE MOIETY068X84E056CUADRIDERMA (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [PROMEX LLC]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UCUADRIDERMA (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [PROMEX LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58988-1170CUADRIDERMA (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [PROMEX LLC]10Current NDC, Legacy NDC, 2 package rows20241105_4fa99b96-ab4b-4523-82bc-343dbaf39fb6.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 OintmentPSN4fa99b96-ab4b-4523-82bc-343dbaf39fb610
1673566Cuadriderma 500 UNT / 3.5 MG / 10,000 UNT / 10 MG per GM Topical OintmentPSN4fa99b96-ab4b-4523-82bc-343dbaf39fb610
1673566bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical Ointment [Cuadriderma]SBD4fa99b96-ab4b-4523-82bc-343dbaf39fb610
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD4fa99b96-ab4b-4523-82bc-343dbaf39fb610
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY4fa99b96-ab4b-4523-82bc-343dbaf39fb610
1673566Cuadriderma (bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG) per GM Topical OintmentSY4fa99b96-ab4b-4523-82bc-343dbaf39fb610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58988-1170-1589881170011 TUBE in 1 CARTON (58988-1170-1) / 28.35 g in 1 TUBE1 tube2013-05-310000-00-00NoNoCurrent