GenRx Anti-Bacterial Gel

Product NDC
59088-299
11-digit product format
590880299
Labeler code
59088
Product ID
59088-299_23733118-0f3a-e4a8-e063-6394a90aa41e
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
PureTek Corporation
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-18
Substance
ALCOHOL
Active strength
62 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59088-29959088-299-48DDiscontinued by firm2026-10-15

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
GenRx Anti-Bacterial Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL62 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581660Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a124e37e-1a44-212a-e053-2995a90a0af0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-299-08GenRx Anti-Bacterial Gel118 mL in 1 BOTTLE, PUMPLIQUID1186
59088-299-31GenRx Anti-Bacterial Gel500 mL in 1 BOTTLE, DISPENSINGLIQUID5006
59088-299-39GenRx Anti-Bacterial Gel710 mL in 1 BOTTLE, PUMPLIQUID7106
59088-299-48GenRx Anti-Bacterial Gel710 mL in 1 BOTTLE, PUMPLIQUID7106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-299GENRX ANTI-BACTERIAL GEL (ALCOHOL) LIQUID [PURETEK CORPORATION]6Current NDC, Legacy NDC, 4 package rows20241004_a124e37e-1a44-212a-e053-2995a90a0af0.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 6 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SuavEar Earwax Removal AidEARWAX REMOVAL AIDNEILMED PHARMACEUTICALS INCc067f1a4-1f67-3f4d-e053-2a95a90a60952024-01-11WarningsExact identifier
application number: M014
Ear Drops MajorCARBAMIDE PEROXIDE 6.5%A-S Medication Solutionseb7df1cc-50db-479a-bc1c-dfd7004dd35b2024-01-08WarningsExact identifier
application number: M014
Wax B Gone Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%SIGMAR, LLC3339cac0-8f32-4f71-bef3-dd1524c4b2442024-01-08WarningsExact identifier
application number: M014
Ear Drops for SwimmersISOPROPYL ALCOHOLPharma Nobis, LLCe42fd693-24ab-0fc0-e053-2995a90ab9542023-12-26WarningsExact identifier
application number: M014
LEADER Ear Drops for SwimmersLEADER EAR DROPS FOR SWIMMERSCardinal Health, 110 dba Leader874857eb-2a9d-6ef7-e053-2995a90af1562023-12-22WarningsExact identifier
application number: M014
Earwax Removal DropsCARBAMIDE PEROXIDE 6.5%Pharma Nobis, LLCe21e114c-99b6-861c-e053-2995a90aeac12023-12-22WarningsExact identifier
application number: M014
Quality Choice Instant Ear DryISOPROPYL ALCOHOLChain Drug Manufacturing Association9d3c681b-a941-6ddb-e053-2a95a90ad3bf2023-12-20WarningsExact identifier
application number: M014
Premiere Value Ear Drops for SwimmersISOPROPYL ALCOHOLPharmacy Value Alliance; LLC9d606fe6-ae57-724f-e053-2a95a90abffe2023-12-20WarningsExact identifier
application number: M014
CVS Ear Drops for SwimmersISOPROPYL ALCOHOLCVS Pharmacycc4614ee-5d6e-4a07-9826-aff12cc35abd2023-12-20WarningsExact identifier
application number: M014
Earwax Removal DropsCARBAMIDE PEROXIDE 6.5%Randob Labs, Ltd.a9904b63-27a4-205c-e053-2995a90af7622023-12-19WarningsExact identifier
application number: M014
DDM Ear Drops for SwimmersISOPROPYL ALCOHOLDiscount Drug Mart5d565cbc-874b-41dc-e053-2991aa0a67872023-12-19WarningsExact identifier
application number: M014
TopCare Swimmers Ear DropsISOPROPYL ALCOHOLTOPCO ASSOCIATES9dccbc25-d954-f917-e053-2a95a90a0eff2023-12-18WarningsExact identifier
application number: M014
HEB Water Drying AidISOPROPYL ALCOHOLH E B5d5741f8-64fd-0a9a-e053-2991aa0a0b5e2023-12-18WarningsExact identifier
application number: M014
Best Choice Earwax Removal KitCARBAMIDE PEROXIDEValu Merchandisers, Co.f943ac0e-8171-446d-8c6c-69612b4826432023-12-15WarningsExact identifier
application number: M014
Quality Choice Earwax Removal KitCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.ba8d71b5-7f1f-44a5-ac5b-1f7ceeb028752023-12-15WarningsExact identifier
application number: M014
DISCOUNT drug mart FOOD FAIR earwax removal kitCARBAMIDE PEROXIDEDiscount Drug Mart83fdf4d6-3cdf-429d-b53d-80775a35d0c92023-12-15WarningsExact identifier
application number: M014
Discount Drug Mart Earwax Removal DropsCARBAMIDE PEROXIDEDiscount Drug Marte30c943e-bba5-4520-8f83-16bfa29ee1cf2023-12-15WarningsExact identifier
application number: M014
HUMCO Ear Drops for SwimmersISOPROPYL ALCOHOLHumco Holding Group, Inc.6f7ba0a6-8dad-47d3-b7c1-6cc9a02808b22023-12-15WarningsExact identifier
application number: M014
Earwax Removal DropsCARBAMIDE PEROXIDE 6.5%Humco Holding Group, Inca8c052d8-fb9c-09f2-e053-2a95a90a37af2023-12-15WarningsExact identifier
application number: M014
EAR DRYING AGENTISOPROPYL ALCOHOL 94.998% GLYCERIN 5%Rite Aid9b4299af-c1a2-43e6-90d4-25f4c89d1bef2023-12-15WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSNa124e37e-1a44-212a-e053-2995a90a0af06
581660ethanol 0.62 ML/ML Topical GelSCDa124e37e-1a44-212a-e053-2995a90a0af06
581660ethanol 62 % Topical GelSYa124e37e-1a44-212a-e053-2995a90a0af06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-299-0859088029908118 mL in 1 BOTTLE, PUMP (59088-299-08) 118 ml2020-03-180000-00-00NoNoCurrent
59088-299-3159088029931500 mL in 1 BOTTLE, DISPENSING (59088-299-31) 500 ml2020-03-180000-00-00NoNoCurrent
59088-299-3959088029939710 mL in 1 BOTTLE, PUMP (59088-299-39) 710 ml2020-03-180000-00-00NoNoCurrent
59088-299-4859088029948710 mL in 1 BOTTLE, PUMP710 mlHistorical