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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63868-945IInactivated by FDA2026-07-31
excluded packagepackage63868-94563868-945-94IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Water-Jel 3-in-1 AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATEWater-Jel Technologiesd5fcaffd-af38-4285-a79c-6df7424c76fa2017-11-16WarningsExact identifier
CVS Triple AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN BCVS Pharmacy454bfeed-f58f-003a-e054-00144ff8d46c2017-01-04WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only Do not use in the eyes or over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor Ask a doctor before use if you have a deep or puncture wounds, animal bites, or serious burns Stop use and ask a doctor if Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away.

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