FDA.reportPublic FDA data

Bacitracin

Product NDC
67777-116
11-digit product format
677770116
Labeler code
67777
Product ID
67777-116_275e9fdf-28d0-498a-e063-6294a90a7eea
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bacitracin
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
58H6RWO52IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1648110Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7f8752c7-6839-261d-e053-2991aa0a0c30Available on FDA.report

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 1 of 22 · 430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dealmed Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEDealmed Medical Supplies, LLC.b3f1e834-4e8f-49f6-af0d-38097ae4f9282026-08-13WarningsExact identifier
application number: M004
First Aid Antibiotic and Burn ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEAmazon.com Services LLC3459a453-0a94-4122-adad-bb120daecd9e2026-08-12WarningsExact identifier
application number: M004
Dealmed BacitracinBACITRACIN ZINCDealmed Medical Supplies, LLC.26f282b5-b3af-4049-93f6-659071be721d2026-08-12WarningsExact identifier
application number: M004
triple antibiotic pain reliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLWalgreen Companyf0fa2822-02a2-49e5-ad47-aa7e9cc2da712026-08-11WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCA-S Medication Solutions9fcda25b-3940-4028-a8ee-6e6c6e4b2a532026-08-07WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATESalado Sales, Inc52e275d3-88c9-47f1-8dcf-68445c7be4a72026-08-05WarningsExact identifier
application number: M004
Wound Wash Antiseptic Saline with Benzalkonium ChlorideWOUND WASH ANTISEPTIC SALINE WITH BENZALKONIUM CHLORIDENeilMed Pharmaceuticals, Inc.55a1fc63-2527-4033-e054-00144ff8d46c2026-08-05WarningsExact identifier
application number: M004
ProcureTriple Antibiotic Triple AntibioticBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN BTWIN MED, LLC71592776-407b-489c-8cdb-8c0573d844f82026-08-03WarningsExact identifier
application number: M004
procureFirst Aid Antibio First Aid AntibioticBACITRACINTWIN MED, LLC8d19e931-99c4-47b8-b7ec-94c16535166f2026-08-03WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEVive Health LLC236c62bf-3de0-0b3e-e063-6394a90ad6c62026-07-21WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEVive Health LLC21b38b00-1e64-83d8-e063-6294a90a07bd2026-07-21WarningsExact identifier
application number: M004
DERMFREE Triple AntibioticTRIPLE ANTIBIOTICJiangxi Yudexi Pharmaceutical Co., LTD4a5a5603-3478-5f7a-e063-6294a90acc402026-07-21WarningsExact identifier
application number: M004
BacitracinBACITRACIN ZINCPreferred Pharmaceuticals Inc.e094566b-3b80-45ac-be73-54c798bbb7632026-07-15WarningsExact identifier
application number: M004
CAREALL BacitracinBACITRACIN ZINCNew World Imports, Inc560ba2ca-ad0f-9202-e063-6294a90aaefd2026-07-14WarningsExact identifier
application number: M004
CareALL Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENew World Imports, Inc561bf89c-ca78-d7e4-e063-6394a90a983f2026-07-14WarningsExact identifier
application number: M004
Good Sense First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BL. Perrigo Company3eadd35c-3df2-4e46-b76d-a6e5378959172026-07-10WarningsExact identifier
application number: M004
CareALL Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLNew World Imports, Inc561c1e51-19f4-90ce-e063-6294a90a5f9b2026-07-08WarningsExact identifier
application number: M004
Ever Ready First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEVER READY FIRST AIDee1ad6d7-e9c1-2b20-e053-2995a90a33662026-07-03WarningsExact identifier
application number: M004
Single Antibiotic with bacitracinBACITRACIN ZINCSafetec of America4ae9a105-e3f9-4015-8844-085e0b34cdb62026-06-25WarningsExact identifier
application number: M004
Antibacterial Hand Wipes (0.13% Benzalkonium Chloride)BENZALKONIUM CHLORIDEEleeo Brands LLC551baf59-39b9-e994-e063-6294a90a65e62026-06-25WarningsExact 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