FDA.reportPublic FDA data

Family Wellness Antiseptic and Pain Relief

Product NDC
69571-007
11-digit product format
695710007
Labeler code
69571
Product ID
69571-007_08a19db8-4da9-6529-e063-6394a90a1b4d
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
FRONT PHARMACEUTICAL PLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-06-13
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
.51; .0035; 1; .01 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], 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 Antiseptic and Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC.51 g/100g
NEOMYCIN SULFATE.0035 g/100g
POLYMYXIN B SULFATE1 g/100g
PRAMOXINE HYDROCHLORIDE.01 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup
057Y626693Internal UNII lookup
19371312D4Internal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cb7fdcde-2bd8-4834-ba4e-4d6fd1512599Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69571-007-01Family Wellness Antiseptic and Pain Relief1 in 1 CARTONOINTMENT14
69571-007-01Family Wellness Antiseptic and Pain Relief28 g in 1 TUBEOINTMENT284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69571-007FAMILY WELLNESS ANTISEPTIC AND PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [FRONT PHARMACEUTICAL PLC]4Current NDC, Legacy NDC, 2 package rows20231027_cb7fdcde-2bd8-4834-ba4e-4d6fd1512599.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 4 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lynx LX0864 peachy-foam antiseptic handsoapCHLOROXYLENOLABC Compounding Co., Inc.dd8025cb-d160-83a4-e053-2a95a90a51ac2026-05-11WarningsExact identifier
application number: M004
Satin Foam High Foaming Antiseptic Hand WashCHLOROXYLENOLCertus Medical, Inc.ea49da65-ae5e-bfde-e053-2a95a90adef22026-05-11WarningsExact identifier
application number: M004
Freshands Premium Foamy Antibacterial Handsoap 6876CHLOROXYLENOLConsolidated Chemicals, LLCf17299a4-28d6-e65b-e053-2a95a90a05e72026-05-11WarningsExact identifier
application number: M004
Harris Teeter Triple Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, PRAMOXINE HCLHARRIS TEETER LLC4b0c0a3c-7145-97ca-e063-6394a90a1a962026-05-07WarningsExact identifier
application number: M004
Harris Teeter Triple AntibioticNEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINCHARRIS TEETER LLC4e81590c-32d3-f8aa-e063-6294a90ab3412026-05-06WarningsExact identifier
application number: M004
FIRSTAR TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.5b9434ad-83d7-4df3-bfef-3db152e6c6cc2026-05-04WarningsExact identifier
application number: M004
oopsie First AidBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE4 Visions LLC50b21f0a-1e87-51ae-e063-6294a90a8a3c2026-04-30WarningsExact identifier
application number: M004
First Aid Kit, Lil Drug Store5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTSLil' Drug Store Products, Inc.503c6c0e-3e1a-71ed-e063-6394a90abfa22026-04-24WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.TRIFECTA PHARMACEUTICALS USA LLC23a35ba8-ebc6-4252-bb88-ec237425056c2026-04-15WarningsExact identifier
application number: M004
El Valle Gentian VioletGENTIAN VIOLET 1%Pharmadel LLCfc75aa2b-0e6e-e2f7-e053-6294a90ac01f2026-04-13WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCSun Pharmaceutical Industries, Inc.4afdeedf-9cdf-47d6-919f-ea907fda02902026-04-10WarningsExact identifier
application number: M004
Family Care Triple Antibiotic Original Formula 0.33ozTRIPLE ANTIBIOTIC ORIGINAL FORMULAUnited Exchange Corp4f1ef127-a67e-ca60-e063-6394a90a3a3d2026-04-10WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEH E B2a143950-13b4-457e-91a4-c61a88aad84b2026-04-02WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4e54f479-ad87-e86b-e063-6394a90aa6d22026-03-31WarningsExact identifier
application number: M004
El Valle MerthiolateBENZALKONIUM CHLORIDEPharmadel LLCfd7b28ca-9f71-0ff6-e053-6394a90a48222026-03-26WarningsExact identifier
application number: M004
sojo Triple AntibioticTRIPLE ANTIBIOTICJiangxi Yudexi Pharmaceutical Co., LTD4d8429bd-24b9-ad3c-e063-6294a90aeba02026-03-21WarningsExact identifier
application number: M004
Neosporin Plus Pain Relief ClubtrayBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf4545718-8643-a340-e053-2995a90a00792026-03-18WarningsExact identifier
application number: M004
BacitracinBACITRACINPreferred Pharmaceuticals Inc.2f115e22-10f5-47fe-85df-f59e4387a3732026-03-16WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4cd49c65-e347-7589-e063-6394a90a53bd2026-03-12WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4cc6d822-f383-2ceb-e063-6294a90aecc72026-03-11WarningsExact identifier
application number: M004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69571-007-01695710007011 TUBE in 1 CARTON (69571-007-01) / 28 g in 1 TUBE1 tube2017-06-130000-00-00NoNoCurrent