FDA.reportPublic FDA data

Bacitracin

Product NDC
67777-116
11-digit product format
677770116
Labeler code
67777
Product ID
67777-116_5c2bc26d-07df-dec4-e063-6294a90ad482
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-09-12
Substance
BACITRACIN
Active strength
500 [USP'U]/1000mg
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Bacitracin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN500 [USP'U]/1000mg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-116-10Bacitracin1728 in 1 CASEOINTMENT172810
67777-116-11Bacitracin144 in 1 BOXOINTMENT14410
67777-116-11Bacitracin900 mg in 1 PACKETOINTMENT90010
67777-116-20Bacitracin72 in 1 CASEOINTMENT7210
67777-116-21Bacitracin14000 mg in 1 TUBEOINTMENT1400010
67777-116-30Bacitracin72 in 1 CASEOINTMENT7210
67777-116-31Bacitracin28400 mg in 1 TUBEOINTMENT2840010
67777-116-31Bacitracin1 in 1 BOXOINTMENT110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-116-10EA - Each67777-11681543e57-a59d-40dc-8dee-7b6749b6bcf412023-07-06
67777-116-11EA - Each67777-1161fd8a2da-8c1f-4251-90e6-f8f313e3687212023-07-06
67777-116-20GM - Gram67777-1163b081bc4-8e96-4dc0-a6cd-6b8e76999f7512023-07-06
67777-116-21GM - Gram67777-116d872c710-0600-45d6-a69e-cbd24ac0b2f512023-07-06
67777-116-30GM - Gram67777-116be7113ed-2faa-4520-b558-009c856210dc12023-07-06
67777-116-31GM - Gram67777-116e1d78b49-c513-4871-9bfe-252a4b32455d12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-116BACITRACIN OINTMENT [DYNAREX CORPORATION]10Current NDC, Legacy NDC, 8 package rows20241122_7f8752c7-6839-261d-e053-2991aa0a0c30.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 · 424 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSN7f8752c7-6839-261d-e053-2991aa0a0c3010
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD7f8752c7-6839-261d-e053-2991aa0a0c3010
1648110bacitracin 500 UNT per GM Topical OintmentSY7f8752c7-6839-261d-e053-2991aa0a0c3010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-116-10677770116101728 BOX in 1 CASE (67777-116-10) / 144 PACKET in 1 BOX (67777-116-11) / 900 mg in 1 PACKET1728 box2016-09-120000-00-00NoNoCurrent
67777-116-1167777011611144 in 1 BOXHistorical
67777-116-206777701162072 TUBE in 1 CASE (67777-116-20) / 14000 mg in 1 TUBE (67777-116-21) 72 tube2016-09-120000-00-00NoNoCurrent
67777-116-216777701162114000 mg in 1 TUBE14000 mgHistorical
67777-116-306777701163072 BOX in 1 CASE (67777-116-30) / 1 TUBE in 1 BOX (67777-116-31) / 28400 mg in 1 TUBE72 box2016-09-120000-00-00NoNoCurrent
67777-116-316777701163128400 mg in 1 TUBE28400 mgHistorical