CAREONE

Product NDC
41520-076
11-digit product format
415200076
Labeler code
41520
Product ID
41520-076_eb308349-f997-4748-808d-2cdd0edec392
Type
HUMAN OTC DRUG
Nonproprietary name
Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
American Sales Company
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-03-21
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
4 mg/g; [iU]/g; mg/g
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
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
41520-076-012020-01-31C16284748780-19d75b9d0-93eb-f424-e053-dadaa90a57ceCAREONE™ Antibiotic Plus Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-076-01CAREONE Antibiotic Plus Pain Relief14.2 g in 1 TUBECREAM14.21
41520-076-01CAREONE Antibiotic Plus Pain Relief1 in 1 CARTONCREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Neomycin SulfateACTIVE INGREDIENT057Y626693CAREONE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [AMERICAN SALES COMPANY]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4CAREONE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [AMERICAN SALES COMPANY]1
Pramoxine HydrochlorideACTIVE INGREDIENT88AYB867L5CAREONE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [AMERICAN SALES COMPANY]1
NeomycinACTIVE MOIETYI16QD7X297CAREONE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [AMERICAN SALES COMPANY]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KCAREONE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [AMERICAN SALES COMPANY]1
PramoxineACTIVE MOIETY068X84E056CAREONE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [AMERICAN SALES COMPANY]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TCAREONE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [AMERICAN SALES COMPANY]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPCAREONE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [AMERICAN SALES COMPANY]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UCAREONE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [AMERICAN SALES COMPANY]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CAREONE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [AMERICAN SALES COMPANY]1
waterINACTIVE INGREDIENT059QF0KO0RCAREONE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [AMERICAN SALES COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-076CAREONE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [AMERICAN SALES COMPANY]1Legacy NDC, 2 package rows20130118_b5156e69-0e52-4961-a5e7-e36001fdd3e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSNb5156e69-0e52-4961-a5e7-e36001fdd3e41
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCDb5156e69-0e52-4961-a5e7-e36001fdd3e41
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSYb5156e69-0e52-4961-a5e7-e36001fdd3e41
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSYb5156e69-0e52-4961-a5e7-e36001fdd3e41
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSYb5156e69-0e52-4961-a5e7-e36001fdd3e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
41520-076-014152000760114.2 g in 1 TUBE14.2 gHistorical