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 18 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Major Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFATMajor Pharmaceuticalsa6cc3fbc-6302-4033-e053-2a95a90a19f02024-09-11WarningsExact identifier
application number: M004
Leader Triple antibioticBACITRACIN,NEOMYCIN,POLYMXINCardinal Health 110 dba LEADER2175e00a-bf85-3377-e063-6394a90a916f2024-09-06WarningsExact identifier
application number: M004
Members Mark Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BSam's West Inc200f4020-7699-4a9e-8fab-2d3df9e768362024-09-05WarningsExact identifier
application number: M004
Leader Poly BacitracinBACITRACIN ZINC POLYMIXIN B SULFATECardinal Health 110 dba LEADER20d7624f-cafa-25e1-e063-6394a90a44392024-08-29WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BMeijer Distribution Incedcb423e-b5c2-4e26-8f7f-9b9ee575042c2024-08-19WarningsExact identifier
application number: M004
Major ClotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals,Inc.562dfc9f-1897-330a-e054-00144ff8d46c2024-08-14WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWildeman Business Group1f96450a-3bda-1f0a-e063-6294a90a514f2024-08-13WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEProvision Medicalbbf4b99c-9738-4855-82a6-f4e213924ec92024-08-09WarningsExact identifier
application number: M004
Tetracyte Topical Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC4ac5177d-bb67-45e6-adcf-44f0821746bd2024-08-01WarningsExact identifier
application number: M004
BacitracinBACITRACINPadagis Israel Pharmaceuticals Ltdbebbedf6-dd65-47a4-aa3e-ad197b3e05a12024-07-31WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCChain Drug Marketing Association Inc.1cd9ded3-068c-496e-e063-6394a90a6a0b2024-07-09WarningsExact identifier
application number: M004
Anti-Itch with AloeHYDROCORTISONE 1%Chain Drug Marketing Association Inc.1cbea7cd-03a0-1469-e063-6294a90a7cc12024-07-08WarningsExact identifier
application number: M004
astonea First AidBACITRACIN ZINCASTONEA LABS PRIVATE LIMITEDde0b2e06-64bc-78f0-e053-2995a90a39a02024-06-25WarningsExact identifier
application number: M004
Publix Bacitracin ZincBACITRACIN ZINCPUBLIX SUPER MARKETS, INC.51f21123-7826-40c9-b2aa-b202125085e22024-06-17WarningsExact identifier
application number: M004
Publix Triple AntibioticBACITRACIN ZINC 400 U, POLYMXYIN B SULFATE 5,000 U, NEOMYCIN SULFATE 3.5MG/GPUBLIX SUPER MARKETS, INC.871fa43c-a1be-4c15-bbfa-a998a2d89d2e2024-06-17WarningsExact identifier
application number: M004
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMNuCare Pharmaceuticals,Inc.66ff9726-20da-688a-e053-2a91aa0a59ac2024-06-06WarningsExact identifier
application number: M004
QC Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.Chain Drug Marketing Association1a1501a4-75b0-5900-e063-6394a90ad77a2024-06-04WarningsExact identifier
application number: M004
Always Save Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLC1a00df31-a38a-fc82-e063-6394a90abbf32024-06-03WarningsExact identifier
application number: M004
PENTREXCILINA TRIPLE ANTIBIOTIC PLUS PAIN RELIEFBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINEOPMX LLC7c0d3cdf-af50-4a65-a01b-a33510feeb942024-05-17WarningsExact identifier
application number: M004
PENIMIXCINABACITRACIN, NEOMYCIN SULFATE, POLYMIXIN B SULFATE, PRAMOXINE HYDROCHLORIDEOPMX LLC92bcbc02-9683-4117-af2b-6d4687796f1f2024-05-17WarningsExact 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