FDA.reportPublic FDA data

NATUREPLEX ANTIBIOTIC plus PAIN RELIEF

Product NDC
67234-068
Requested package NDC
67234-068-02
11-digit product format
672340068
Labeler code
67234
Product ID
67234-068_5c7bf435-0722-43f9-8d3b-2b0e14d15981
Type
HUMAN OTC DRUG
Nonproprietary name
NEOMYCIN SULFATE, POLYMYXIN B SULFATE, and PRAMOXINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Natureplex
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-12-06
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
4 mg/9.4g; [iU]/9.4g; mg/9.4g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67234-06867234-068-02IInactivated by FDA2026-10-12

Reported adverse events (FAERS/openFDA)#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67234-068-01NATUREPLEX ANTIBIOTIC plus PAIN RELIEF1 in 1 CARTONCREAM13
67234-068-01NATUREPLEX ANTIBIOTIC plus PAIN RELIEF9.4 g in 1 TUBECREAM9.43
67234-068-02NATUREPLEX ANTIBIOTIC plus PAIN RELIEF28 g in 1 TUBECREAM283
67234-068-02NATUREPLEX ANTIBIOTIC plus PAIN RELIEF1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-068NATUREPLEX ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [NATUREPLEX]3Legacy NDC, 4 package rows20250101_0b9e4364-b7ea-44ee-bb27-2804976ee158.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 CreamPSN0b9e4364-b7ea-44ee-bb27-2804976ee1583
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD0b9e4364-b7ea-44ee-bb27-2804976ee1583
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSY0b9e4364-b7ea-44ee-bb27-2804976ee1583
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSY0b9e4364-b7ea-44ee-bb27-2804976ee1583
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSY0b9e4364-b7ea-44ee-bb27-2804976ee1583

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67234-068-02672340068021 TUBE in 1 CARTON (67234-068-02) > 28 g in 1 TUBE1 tube2021-12-140000-00-00NoNoCurrent