FDA.reportPublic FDA data

QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER

Product NDC
63868-945
11-digit product format
638680945
Labeler code
63868
Product ID
63868-945_77e0cd5d-ee86-4a22-bb22-953136742c9c
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-02-09
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
500 [USP'U]/g; mg/g; [USP'U]/g; mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
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
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
63868-945-942019-11-13C16284748780-197449f38-c0aa-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-945-94QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER28 g in 1 TUBEOINTMENT287
63868-945-94QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER1 in 1 CARTONOINTMENT17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESQUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]7
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]7
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]7
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]7
BACITRACINACTIVE MOIETY58H6RWO52IQUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]7
NEOMYCINACTIVE MOIETYI16QD7X297QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]7
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KQUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]7
PRAMOXINEACTIVE MOIETY068X84E056QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TQUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]7
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UQUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HQUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]7
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHQUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]7
WATERINACTIVE INGREDIENT059QF0KO0RQUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-945QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]7Legacy NDC, 2 package rows20120224_dced282a-97f6-44a3-b3ab-bc19912844bd.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 OintmentPSNdced282a-97f6-44a3-b3ab-bc19912844bd7
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCDdced282a-97f6-44a3-b3ab-bc19912844bd7
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSYdced282a-97f6-44a3-b3ab-bc19912844bd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63868-945-946386809459428 g in 1 TUBE28 gHistorical