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 10 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FifthPulse Hydrocortisone 4ozHYDROCORTISONEFront Pharmaceutical PLC39fb29c8-6a28-e87e-e063-6294a90a78da2025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEFred's, Inc.41ee7a50-d36b-4214-b6f8-44f47ab44a842025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATELidl US, LLC98389314-c2cf-4510-ab3d-41c4c47200192025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN BPublix Super Markets Inc72bdb96c-af93-4a9b-93d9-81a94b6ff7562025-07-15WarningsExact identifier
application number: M004
Live Better Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEThe Great Atlantic & Pacific Tea Company7e7a0b4c-67a9-42f3-aacd-2606fde250902025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATETopco Associates LLC55a8a52c-4d03-417d-9283-406f6879bcb52025-07-15WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEFRED'S, INC.a44db5d1-7a74-44aa-9aa7-6247e771aaf22025-07-15WarningsExact identifier
application number: M004
Shopko Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEShopko Stores Operating Co., LLC5a9b2ea4-9b9d-4147-8aa0-7313d6be2cfa2025-07-15WarningsExact identifier
application number: M004
sunmark triple antibiotic plus pain reliefPOLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC941a6a71-e898-4af3-989a-6d3aa32243382025-07-15WarningsExact identifier
application number: M004
TopCare Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETopco Associates LLC0fc0dbc6-ca1d-42be-8016-68e64f1197062025-07-15WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalgreen Companye2b7fc5b-c796-4ed1-aea7-4c810df250d52025-07-15WarningsExact identifier
application number: M004
Publix antibiotic plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEPublix Super Markets Incd0193bf1-a257-490e-a058-5e6a514981da2025-07-15WarningsExact identifier
application number: M004
Live Better Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEThe Great Atlantic & Pacific Tea Company7d3435ad-7d73-4db6-8019-3040b3dadfa92025-07-14WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEWal-Mart Stores, Inc.f5199476-1ce2-4a82-9685-40d78b7a89352025-07-14WarningsExact identifier
application number: M004
Double AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATESTRATEGIC SOURCING SERVICES LLC38414fff-8dad-44d0-9dfa-f89a63ef9b442025-07-14WarningsExact identifier
application number: M004
sunmark double antibioticBACITRACIN ZINC AND POLYMYXIN B SULFATEStrategic Sourcing Services LLC2868de5c-4894-45ee-9647-9acd3bde7cfc2025-07-14WarningsExact identifier
application number: M004
Live Better Bacitracin ZincBACITRACIN ZINCThe Great Atlantic & Pacific Tea Company6915940c-2eae-445c-ba58-e39d221e9d3d2025-07-11WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCSTRATEGIC SOURCING SERVICES LLC4594948d-1f25-4d3c-a615-9e6edda05a102025-07-11WarningsExact identifier
application number: M004
Good Neighbor Pharmacy Bacitracin ZincBACITRACIN ZINCAmerisourceBergen3fb302b5-7273-412c-a2ba-b76183e3f1792025-07-11WarningsExact identifier
application number: M004
TopCare Bacitracin ZincBACITRACIN ZINCTopco Associates LLC5b59e26d-cc25-49a6-ac8b-f79398e18f2d2025-07-07WarningsExact 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