FDA.reportPublic FDA data

TopCare

Product NDC
36800-089
11-digit product format
368000089
Labeler code
36800
Product ID
36800-089_395c0efb-f780-1635-e063-6394a90abf53
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-05-11
Substance
BACITRACIN ZINC
Active strength
500 [iU]/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
TopCare
Brand name suffix
Bacitracin Zinc
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [iU]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1366116Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5b59e26d-cc25-49a6-ac8b-f79398e18f2dAvailable 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
36800-089-02TopCareBacitracin Zinc28.4 g in 1 TUBEOINTMENT28.44
36800-089-02TopCareBacitracin Zinc1 in 1 CARTONOINTMENT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-089-02GM - Gram36800-0893d2954cb-9d1e-462e-83d6-8d69753dd14112018-05-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESTOPCARE BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [TOPCO ASSOCIATES LLC]1
BacitracinACTIVE MOIETY58H6RWO52ITOPCARE BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [TOPCO ASSOCIATES LLC]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPTOPCARE BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [TOPCO ASSOCIATES LLC]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UTOPCARE BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-089TOPCARE BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 2 package rows20241107_5b59e26d-cc25-49a6-ac8b-f79398e18f2d.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 9 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibiotic Maximum StrengthBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWalgreens9a092f24-65b2-4b57-8103-265ea3e033112025-09-02WarningsExact identifier
application number: M004
AerosootheTRIPLE ANTIBIOTIC OINTMENTAero Healthcare US LLC2287a31c-750c-728d-e054-00144ff88e882025-08-29WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEChain Drug Marketing Association Inc.3d4b3d73-171a-bc6a-e063-6394a90a69c12025-08-26WarningsExact identifier
application number: M004
Dual Action CreamNEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCLTrifecta Pharmaceutical USA LLCb84015ae-9c76-b1d7-e053-2a95a90a2cc82025-08-23WarningsExact identifier
application number: M004
Natureplex Antibiotic Plus Pain, Itch, Scar ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDENatureplex LLCf0af8829-72fb-46b1-9328-6f4920710bb12025-08-15WarningsExact identifier
application number: M004
PROHEAL TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.6c61d88e-4ced-4468-8f99-91652f7a03e42025-08-13WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEJ&A Digital Inc.9f006f16-083d-4e95-aec2-6ef83405f3932025-08-07WarningsExact identifier
application number: M004
Vitacilina First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETaisho Pharmaceutical California Inc.93fb9e05-f78c-4d37-b6f1-926cbcb2e7a72025-08-07WarningsExact identifier
application number: M004
SurviveX Triple AntibioticTRIPLE ANTIBIOTIC OINTMENTNantong Health & Beyond Hygienic Products Inc.3bd25bb6-6486-8a0a-e063-6394a90a085c2025-08-07WarningsExact identifier
application number: M004
Thera Plus Original Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEFOURSTAR GROUP USA, INC.09e8bdb7-dc14-4f28-8306-c0e2bf73f0812025-07-31WarningsExact identifier
application number: M004
BacitracinBACITRACINBryant Ranch Prepack0c081802-429f-468f-9650-293cb7a1ad342025-07-29WarningsExact identifier
application number: M004
health and .beyond Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0070ea5f-434d-53a7-e063-6294a90abf182025-07-27WarningsExact identifier
application number: M004
health and beyond TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.13cbe416-a146-447d-be36-8b3af9b3c8952025-07-27WarningsExact identifier
application number: M004
AOSI HEALTHCARE TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.70c53369-7cf6-4352-a19f-c85a55c5a4bd2025-07-27WarningsExact identifier
application number: M004
Pomada de SulfaNEOMYCIN SULFATEMenper Distributors, Inc.216f4d22-e5e8-46c8-a4ef-8d1532792b562025-07-22WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATESTRATEGIC SOURCING SERVICES LLC1bda9c30-8fc8-4814-b211-94550672b22f2025-07-21WarningsExact identifier
application number: M004
Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC6a61c900-2dfc-4c07-8ae5-32ffbd89d2b62025-07-21WarningsExact identifier
application number: M004
FifthPulse Bacitracin Zinc 1ozBACITRACIN ZINCFront Pharmaceutical PLC39f994d4-5f41-fb34-e063-6294a90a45ea2025-07-15WarningsExact identifier
application number: M004
FifthPulse Bacitracin Zinc 4ozBACITRACIN ZINCFront Pharmaceutical PLC39fa0e5f-b794-e1e3-e063-6394a90a4ce32025-07-15WarningsExact identifier
application number: M004
FifthPulse Hydrocortisone 1ozHYDROCORTISONEFront Pharmaceutical PLC39fae2a4-902e-3c88-e063-6394a90acbd52025-07-15WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN5b59e26d-cc25-49a6-ac8b-f79398e18f2d4
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD5b59e26d-cc25-49a6-ac8b-f79398e18f2d4
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY5b59e26d-cc25-49a6-ac8b-f79398e18f2d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-089-02368000089021 TUBE in 1 CARTON (36800-089-02) / 28.4 g in 1 TUBE1 tube2006-05-110000-00-00NoNoCurrent