FDA.reportPublic FDA data

FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF

Product NDC
55319-033
11-digit product format
553190033
Labeler code
55319
Product ID
55319-033_80c68765-ae5a-d554-e053-2a91aa0a966f
Type
HUMAN OTC DRUG
Nonproprietary name
Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine HCI
Dosage form
CREAM
Route
TOPICAL
Labeler
FAMILY DOLLAR
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-10-15
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
4 mg/g; [USP'U]/g; mg/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
55319-033-282022-01-28C16284748780-1d6a99b39-6a15-a426-e053-dadaa90af4c2Family Wellness Triple Antibiotic Pain Relief Cream 1 oz. 3326 (2018)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-033-28FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF28 g in 1 TUBECREAM285
55319-033-28FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF1 in 1 CARTONCREAM15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEOMYCINACTIVE INGREDIENTI16QD7X297FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]2
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]2
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]2
NEOMYCINACTIVE MOIETYI16QD7X297FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]2
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KFAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]2
PRAMOXINEACTIVE MOIETY068X84E056FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPFAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UFAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MFAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]2
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XFAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]2
WATERINACTIVE INGREDIENT059QF0KO0RFAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) CREAM [FAMILY DOLLAR]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-033FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HCI) CREAM [FAMILY DOLLAR]5Legacy NDC, 2 package rows20190201_9f0313a2-3e80-4b93-8362-3e5ea55b29e7.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 CreamPSN9f0313a2-3e80-4b93-8362-3e5ea55b29e75
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD9f0313a2-3e80-4b93-8362-3e5ea55b29e75
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSY9f0313a2-3e80-4b93-8362-3e5ea55b29e75
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSY9f0313a2-3e80-4b93-8362-3e5ea55b29e75
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSY9f0313a2-3e80-4b93-8362-3e5ea55b29e75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-033-28553190033281 TUBE in 1 CARTON (55319-033-28) > 28 g in 1 TUBE1 tube2012-10-150000-00-00NoNoCurrent