FDA.reportPublic FDA data

Family Wellness First Aid Antibiotic

Product NDC
69396-037
11-digit product format
693960037
Labeler code
69396
Product ID
69396-037_298d8c06-7975-7cc0-e063-6394a90a3e43
Type
HUMAN OTC DRUG
Nonproprietary name
Family Wellness bacitracin zinc, polymyxin B sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA, LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-29
Substance
POLYMYXIN B SULFATE; BACITRACIN ZINC
Active strength
10000; 500 [USP'U]/g; [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Family Wellness First Aid Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYMYXIN B SULFATE10000 [USP'U]/g
BACITRACIN ZINC500 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19371312D4Internal UNII lookup
89Y4M234ESInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308512Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9157681a-3ed1-096e-e053-2a95a90a05e3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-037-04Family Wellness First Aid Antibiotic1 in 1 BOXOINTMENT19
69396-037-04Family Wellness First Aid Antibiotic14.2 g in 1 TUBEOINTMENT14.29
69396-037-05Family Wellness First Aid Antibiotic15 g in 1 TUBEOINTMENT159
69396-037-05Family Wellness First Aid Antibiotic1 in 1 BOXOINTMENT19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-037FAMILY WELLNESS FIRST AID ANTIBIOTIC (FAMILY WELLNESS BACITRACIN ZINC, POLYMYXIN B SULFATE) OINTMENT [TRIFECTA PHARMACEUTICALS USA, LLC]9Current NDC, Legacy NDC, 4 package rows20241220_9157681a-3ed1-096e-e053-2a95a90a05e3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATENuCare Pharmaceutical, Inc.5b14499e-e45c-7c05-e063-6294a90a1cc22026-09-09WarningsExact identifier
application number: M004
American Safety and First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Inceb0df2da-1688-c477-e053-2995a90a74a22026-09-07WarningsExact identifier
application number: M004
American Safety and First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Inceb0d108f-42bf-3364-e053-2a95a90a45422026-09-07WarningsExact identifier
application number: M004
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e4d0a4-b90c-99b0-e053-2995a90ab4232026-09-04WarningsExact identifier
application number: M004
Lil Drug Store Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEORAZEN INCe6e5263b-328f-4775-9fac-34302f050ce02026-09-04WarningsExact identifier
application number: M004
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e42c5c-e080-4efb-e053-2a95a90af52e2026-09-04WarningsExact identifier
application number: M004
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e4854a-ee01-df72-e053-2995a90aa8ea2026-09-04WarningsExact identifier
application number: M004
Circle K Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEORAZEN INC84c3f7e4-b28b-40bb-8d9d-7c8d679e3a3a2026-09-04WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLWalgreen Companyb982091a-5aa0-4bbc-bb1d-08016f6d0a702026-09-03WarningsExact identifier
application number: M004
SurviveX Triple AntibioticTRIPLE ANTIBIOTICNantong Health & Beyond Hygienic Products Inc.5a7cb52d-a60c-b947-e063-6394a90afb0d2026-09-02WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BWalgreen Company4f3cfe39-2df8-48b4-954d-5997217c92ba2026-08-31WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINCNINGBO TIANBO FIRST AID PRODUCT CO., LTD.217aa2b8-94f5-468a-99b4-52824a77b5732026-08-28WarningsExact identifier
application number: M004
OP Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEYiwu Ori-Power Medtech Co., Ltd.03f3cce9-7e9f-90a6-e063-6294a90a660b2026-08-28WarningsExact identifier
application number: M004
Alcare Extra Hand SanitizerALCOHOLSC Johnson Professional USA Inc.5dc007a2-61fa-4115-a82c-1aa489a6bd392026-08-27WarningsExact identifier
application number: M004
InstantFoam Complete PUREALCOHOLSC Johnson Professional USA Inc.398ca23c-7202-4670-be14-9829675f71742026-08-27WarningsExact identifier
application number: M004
Be Smart Get Prepared Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETotal Resources International, Inc57ed1a03-7e1b-4eb4-8001-dfd118805edc2026-08-24WarningsExact identifier
application number: M004
ClaravieBACITRACIN ZINCGentell LLC59c5a363-6d79-d07e-e063-6294a90a87532026-08-24WarningsExact identifier
application number: M004
ClaravieBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN BGentell LLC597cb2f0-ff05-a1ab-e063-6294a90acda92026-08-20WarningsExact identifier
application number: M004
Medpride First AidBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEShield Line LLC5ba3e703-7873-4724-a0bf-bb22d8a257482026-08-18WarningsExact identifier
application number: M004
Medpride First AidBACITRACIN ZINCShield Line LLCe6a6fb0f-5ab7-4647-84a0-7b9948eed3032026-08-18WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSN9157681a-3ed1-096e-e053-2a95a90a05e39
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCD9157681a-3ed1-096e-e053-2a95a90a05e39
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSY9157681a-3ed1-096e-e053-2a95a90a05e39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-037-04693960037041 TUBE in 1 BOX (69396-037-04) / 14.2 g in 1 TUBE1 tube2020-01-100000-00-00NoNoCurrent
69396-037-05693960037051 TUBE in 1 BOX (69396-037-05) / 15 g in 1 TUBE1 tube2019-08-300000-00-00NoNoCurrent