Family Wellness Plus Pain Relief

Product NDC
69396-043
11-digit product format
693960043
Labeler code
69396
Product ID
69396-043_98fac7f9-0d41-8da5-e053-2995a90a8390
Type
HUMAN OTC DRUG
Nonproprietary name
Family Wellness Neomycin,PolymyxinB,PramoxineHCL
Dosage form
CREAM
Route
TOPICAL
Labeler
Trifecta Pharmaceutical USA LLC
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-08-30
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE
Active strength
4 mg/g; mg/g; [USP'U]/g
NDC exclude flag
No
Listing certified through
2020-12-31
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
69396-043-012021-01-29C16284748780-1ba0f9c33-169e-a910-e053-dadaa90a0b85Triple Antibiotic + Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-043-01Family Wellness Plus Pain Relief28.4 g in 1 TUBECREAM28.44
69396-043-01Family Wellness Plus Pain Relief1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-043FAMILY WELLNESS PLUS PAIN RELIEF (FAMILY WELLNESS NEOMYCIN,POLYMYXINB,PRAMOXINEHCL) CREAM [TRIFECTA PHARMACEUTICAL USA LLC]4Legacy NDC, 2 package rows20191221_9350688e-f456-d9e5-e053-2995a90aa8bb.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 CreamPSN9350688e-f456-d9e5-e053-2995a90aa8bb4
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD9350688e-f456-d9e5-e053-2995a90aa8bb4
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSY9350688e-f456-d9e5-e053-2995a90aa8bb4
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSY9350688e-f456-d9e5-e053-2995a90aa8bb4
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSY9350688e-f456-d9e5-e053-2995a90aa8bb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69396-043-016939600430128.4 g in 1 TUBE28.4 gHistorical