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
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500; 10000 [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

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
BACITRACIN ZINC500 [USP'U]/g
POLYMYXIN B SULFATE10000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 19371312D4
Rxcui308512

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

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