FDA.reportPublic FDA data

Gerigentle-Bacitracin zinc

Product NDC
69771-106
11-digit product format
697710106
Labeler code
69771
Product ID
69771-106_41d61178-65a8-9310-e063-6394a90a5f5e
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Geri-Gentle Corporation
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-15
Substance
BACITRACIN ZINC
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69771-106-34ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69771-106-35ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69771-106-34367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69771-106-35367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69771-106-34557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69771-106-35557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69771-106-348af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69771-106-358af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69771-106-34834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69771-106-35834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69771-106-341332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69771-106-351332a3947898…d4bfe170f9cd…

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
Gerigentle-Bacitracin zinc
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/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
7e36e4d0-eac3-4aa3-81a7-e21c224b1cd4Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69771-106-342025-01-06Gerigentle-Bacitracin zinc
69771-106-342025-01-06Gerigentle-Bacitracin zinc
69771-106-352025-01-06Gerigentle-Bacitracin zinc
69771-106-352025-01-06Gerigentle-Bacitracin zinc
69771-106-342023-01-30Gerigentle-Bacitracin zinc
69771-106-342023-01-30Gerigentle-Bacitracin zinc
69771-106-352023-01-30Gerigentle-Bacitracin zinc
69771-106-352023-01-30Gerigentle-Bacitracin zinc
69771-106-342020-02-06Gerigentle-Bacitracin zinc
69771-106-342020-02-06Gerigentle-Bacitracin zinc
69771-106-352020-02-06Gerigentle-Bacitracin zinc
69771-106-352020-02-06Gerigentle-Bacitracin zinc
69771-106-342020-01-31Gerigentle-Bacitracin zinc
69771-106-342020-01-31Gerigentle-Bacitracin zinc
69771-106-352020-01-31Gerigentle-Bacitracin zinc
69771-106-352020-01-31Gerigentle-Bacitracin zinc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69771-106-34Gerigentle-Bacitracin zinc0.9 g in 1 PACKETOINTMENT0.97
69771-106-34Gerigentle-Bacitracin zinc144 in 1 BOXOINTMENT1447
69771-106-35Gerigentle-Bacitracin zinc28 g in 1 TUBEOINTMENT287
69771-106-35Gerigentle-Bacitracin zinc1 in 1 CARTONOINTMENT17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69771-106GERIGENTLE-BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [GERI-GENTLE CORPORATION]6Current NDC, Legacy NDC, 4 package rows20250108_7e36e4d0-eac3-4aa3-81a7-e21c224b1cd4.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 17 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple Antibiotic plus pain reliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLKroger Companye31c8d92-bf9f-4b7f-8f81-54199745cd202024-10-06WarningsExact identifier
application number: M004
careone triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEAmerican Sales Company9df0c4c2-f045-4f25-878e-4d55a99b8df42024-10-06WarningsExact identifier
application number: M004
DG Health AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLDolgencorp, LLC0a04da51-d169-4eff-b70c-352913ce39662024-10-06WarningsExact identifier
application number: M004
Signature Care Triple AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLSafeway8d5bac6b-98b6-4fc4-983a-ca5292b4c3612024-10-06WarningsExact identifier
application number: M004
antibiotic plus pain reliefNEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEKroger Company91828614-d0d1-472f-802f-43f4738601252024-09-26WarningsExact identifier
application number: M004
DG Health AntibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLDolgencorp Incefaf3ea5-0a2f-414f-96eb-7e8cfba9e9012024-09-26WarningsExact identifier
application number: M004
Good Sense First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BA-S Medication Solutions29c223ff-3cb7-4578-a326-08516e89cd472024-09-26WarningsExact identifier
application number: M004
Signature Care First Aid AntibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLSafeway78ecfb28-f4c4-4f70-90c9-d6d7bf920fb52024-09-26WarningsExact identifier
application number: M004
Good Neighbor Pharmacy Antibiotic and Pain ReliefNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLAmerisource Bergen3d1694ea-3f3e-45d5-8edf-8b31ac7d3a402024-09-26WarningsExact identifier
application number: M004
Rexall AntibioticBACITRACINDolgencorp, LLC7ad42602-6e42-47c8-91a8-e4785fa8d24b2024-09-23WarningsExact identifier
application number: M004
bacitracinBACITRACINH E B0a5eeef0-309b-4edd-a664-3d9c1c74a6e92024-09-23WarningsExact identifier
application number: M004
signature care first aid antibioticBACITRACINSafeway38fc0c5c-e0bc-44d2-acbd-d4d329fef1e12024-09-23WarningsExact identifier
application number: M004
AntibioticBACITRACINTopco Associates LLC3267a695-9e53-42f2-b30a-022653a0b8bb2024-09-23WarningsExact identifier
application number: M004
BacitracinBACITRACINKroger Company4490cece-0635-4ea7-91ab-324a971fef632024-09-23WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BPadagis Israel Pharmaceuticals Ltd28fff253-ddd4-4669-aa90-b4caf48c905f2024-09-22WarningsExact identifier
application number: M004
Signature Care Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BSafeway044aff98-f398-40f5-8c18-2751b4ab43842024-09-18WarningsExact identifier
application number: M004
careone triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAmerican Sales Company09a0b0b9-1806-4ff9-80fa-448dabbf2cc72024-09-18WarningsExact identifier
application number: M004
equaline first aid antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BUnited Natural Foods, Inc. dba UNFI022e009e-0192-4089-86f3-4d63448e0f882024-09-18WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BKroger Companyc531bac4-ab15-4fde-99a7-19e20ce103872024-09-17WarningsExact identifier
application number: M004
basic care first aid antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BAmazon.com Services LLCc159b18d-0d6e-409f-8b2b-e8f28cd856332024-09-17WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN7e36e4d0-eac3-4aa3-81a7-e21c224b1cd47
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD7e36e4d0-eac3-4aa3-81a7-e21c224b1cd47
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY7e36e4d0-eac3-4aa3-81a7-e21c224b1cd47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69771-106-3469771010634144 PACKET in 1 BOX (69771-106-34) / .9 g in 1 PACKET144 packet2015-01-150000-00-00NoNoCurrent
69771-106-35697710106351 TUBE in 1 CARTON (69771-106-35) / 28 g in 1 TUBE1 tube2015-01-150000-00-00NoNoCurrent