FDA.reportPublic FDA data

Rexall Antibiotic

Product NDC
55910-536
11-digit product format
559100536
Labeler code
55910
Product ID
55910-536_0b3913da-2bc7-4d3f-88cd-8b2005863fde
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dolgencorp, LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-09-22
Substance
BACITRACIN
Active strength
500 [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
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
Rexall Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

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

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
7ad42602-6e42-47c8-91a8-e4785fa8d24bAvailable 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
55910-536-64Rexall Antibiotic1 in 1 CARTONOINTMENT16
55910-536-64Rexall Antibiotic28 g in 1 TUBEOINTMENT286

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACINACTIVE INGREDIENT58H6RWO52IREXALL ANTIBIOTIC (BACITRACIN) OINTMENT [DOLGENCORP, LLC]1
BACITRACINACTIVE MOIETY58H6RWO52IREXALL ANTIBIOTIC (BACITRACIN) OINTMENT [DOLGENCORP, LLC]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPREXALL ANTIBIOTIC (BACITRACIN) OINTMENT [DOLGENCORP, LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UREXALL ANTIBIOTIC (BACITRACIN) OINTMENT [DOLGENCORP, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-536REXALL ANTIBIOTIC (BACITRACIN) OINTMENT [DOLGENCORP, LLC]6Current NDC, Legacy NDC, 2 package rows20240925_7ad42602-6e42-47c8-91a8-e4785fa8d24b.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 5 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ora Zen Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incabbf8c34-87cb-4366-9840-7264a5114b542026-03-11WarningsExact identifier
application number: M004
FM-24 FOAMINGCHLOROXYLENOLPeople's Janitorial Supplyb3c2e174-6099-ba08-e053-2995a90a72902026-03-10WarningsExact identifier
application number: M004
doubleantibioticointmentBACITRACIN ZINC, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA LLC4eb5202e-8e5b-6d31-e054-00144ff88e882026-03-04WarningsExact identifier
application number: M004
Neomycin SulfateNEOMYCIN SULFATEAldermed Inc.4978bb06-8b7c-9a44-e063-6294a90ac4cf2026-02-12WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATENatureplex LLCfbb64891-2219-451d-96b0-e7c0430fadda2026-02-12WarningsExact identifier
application number: M004
Double AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATESTRATUS PHARMACEUTICALS INCf64b3564-ea3c-4316-8f00-f92c08dcad352026-02-04WarningsExact identifier
application number: M004
TheraCare Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, AND PRAMIXINE HCLVeridian Healthcared2374664-4668-4da5-9df7-44e6e421ad542026-01-29WarningsExact identifier
application number: M004
TheraCare Bacitracin ZincFIRST AID ANTIBIOTICVeridian Healthcare8217648d-5acb-4a1e-913f-43695f4e01ad2026-01-29WarningsExact identifier
application number: M004
Equate First Aid Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMart907d44c5-cbd1-4d13-8c5c-c164f7a536e52026-01-29WarningsExact identifier
application number: M004
Natureplex Antibiotic plus PainBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDENatureplex, LLC317acec2-8ab7-4b62-9d72-f98cab4f979c2026-01-29WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4963f926-3d48-36de-e063-6294a90a9acc2026-01-27WarningsExact identifier
application number: M004
A-Cute Derm AntisepationBENZETHONIUM CHLORIDEABBE Laboratories, Inc.d7e69169-dc8a-4ad7-b8bb-d97a5d30cbec2026-01-24WarningsExact identifier
application number: M004
A-Cute Derm B-KleerBENZETHONIUM CHLORIDEABBE Laboratories, Inc.544333fe-6c3a-485b-b899-e029d97ea9622026-01-24WarningsExact identifier
application number: M004
Brace ReliefBENZOCAINEInfaLab,Incd7e57d67-4234-44a9-bbd3-72e99cd5bdb32026-01-16WarningsExact identifier
application number: M004
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLC0e1f57c4-8b46-b8cc-e063-6294a90a0ebb2026-01-15WarningsExact identifier
application number: M004
ViaDerma Care Tetracycline HCl First Aid AntibioticTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.5437777e-7f2b-412d-a2f5-380c09de4b1d2026-01-14WarningsExact identifier
application number: M004
Hermon bed sore and pressure sore creamCALENDULA OFFICINALIS1X HPUS 1.5%Beautivity LLC48053402-b6c8-0443-e063-6294a90abce72026-01-10WarningsExact identifier
application number: M004
Walgreens Arthritis Pain Relief Capsaicin AnalgesicCAPSAICINWalgreen Companyda818dd5-bf64-46c2-a3ad-440b2874edbb2026-01-09WarningsExact identifier
application number: M004
QS Plus Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDEABC Compounding Co., Inc.343f9139-47bc-44b0-9da1-d9d6f6334bc72026-01-06WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC AND NEOMYCIN AND POLYMYXIN B SULFATEMelaleuca, Inc.65ae4607-689d-6056-e053-2a91aa0aff562025-12-31WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSN7ad42602-6e42-47c8-91a8-e4785fa8d24b6
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD7ad42602-6e42-47c8-91a8-e4785fa8d24b6
1648110bacitracin 500 UNT per GM Topical OintmentSY7ad42602-6e42-47c8-91a8-e4785fa8d24b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-536-64559100536641 TUBE in 1 CARTON (55910-536-64) / 28 g in 1 TUBE1 tube2015-09-220000-00-00NoNoCurrent