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 18 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Major Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFATMajor Pharmaceuticalsa6cc3fbc-6302-4033-e053-2a95a90a19f02024-09-11WarningsExact identifier
application number: M004
Leader Triple antibioticBACITRACIN,NEOMYCIN,POLYMXINCardinal Health 110 dba LEADER2175e00a-bf85-3377-e063-6394a90a916f2024-09-06WarningsExact identifier
application number: M004
Members Mark Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BSam's West Inc200f4020-7699-4a9e-8fab-2d3df9e768362024-09-05WarningsExact identifier
application number: M004
Leader Poly BacitracinBACITRACIN ZINC POLYMIXIN B SULFATECardinal Health 110 dba LEADER20d7624f-cafa-25e1-e063-6394a90a44392024-08-29WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BMeijer Distribution Incedcb423e-b5c2-4e26-8f7f-9b9ee575042c2024-08-19WarningsExact identifier
application number: M004
Major ClotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals,Inc.562dfc9f-1897-330a-e054-00144ff8d46c2024-08-14WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWildeman Business Group1f96450a-3bda-1f0a-e063-6294a90a514f2024-08-13WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEProvision Medicalbbf4b99c-9738-4855-82a6-f4e213924ec92024-08-09WarningsExact identifier
application number: M004
Tetracyte Topical Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC4ac5177d-bb67-45e6-adcf-44f0821746bd2024-08-01WarningsExact identifier
application number: M004
BacitracinBACITRACINPadagis Israel Pharmaceuticals Ltdbebbedf6-dd65-47a4-aa3e-ad197b3e05a12024-07-31WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCChain Drug Marketing Association Inc.1cd9ded3-068c-496e-e063-6394a90a6a0b2024-07-09WarningsExact identifier
application number: M004
Anti-Itch with AloeHYDROCORTISONE 1%Chain Drug Marketing Association Inc.1cbea7cd-03a0-1469-e063-6294a90a7cc12024-07-08WarningsExact identifier
application number: M004
astonea First AidBACITRACIN ZINCASTONEA LABS PRIVATE LIMITEDde0b2e06-64bc-78f0-e053-2995a90a39a02024-06-25WarningsExact identifier
application number: M004
Publix Bacitracin ZincBACITRACIN ZINCPUBLIX SUPER MARKETS, INC.51f21123-7826-40c9-b2aa-b202125085e22024-06-17WarningsExact identifier
application number: M004
Publix Triple AntibioticBACITRACIN ZINC 400 U, POLYMXYIN B SULFATE 5,000 U, NEOMYCIN SULFATE 3.5MG/GPUBLIX SUPER MARKETS, INC.871fa43c-a1be-4c15-bbfa-a998a2d89d2e2024-06-17WarningsExact identifier
application number: M004
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMNuCare Pharmaceuticals,Inc.66ff9726-20da-688a-e053-2a91aa0a59ac2024-06-06WarningsExact identifier
application number: M004
QC Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.Chain Drug Marketing Association1a1501a4-75b0-5900-e063-6394a90ad77a2024-06-04WarningsExact identifier
application number: M004
Always Save Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLC1a00df31-a38a-fc82-e063-6394a90abbf32024-06-03WarningsExact identifier
application number: M004
PENTREXCILINA TRIPLE ANTIBIOTIC PLUS PAIN RELIEFBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINEOPMX LLC7c0d3cdf-af50-4a65-a01b-a33510feeb942024-05-17WarningsExact identifier
application number: M004
PENIMIXCINABACITRACIN, NEOMYCIN SULFATE, POLYMIXIN B SULFATE, PRAMOXINE HYDROCHLORIDEOPMX LLC92bcbc02-9683-4117-af2b-6d4687796f1f2024-05-17WarningsExact 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