FDA.reportPublic FDA data

Antiseptic

Product NDC
66977-032
Requested package NDC
66977-032-08
11-digit product format
669770032
Labeler code
66977
Product ID
66977-032_471c8cbc-1bec-3105-e063-6394a90a3cd3
Type
HUMAN OTC DRUG
Nonproprietary name
benzethonium chloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
MPM Medical, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1997-06-01
Substance
BENZETHONIUM CHLORIDE
Active strength
1 mg/mL
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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05110d247fa046…a55b01930146…

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
Antiseptic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PH41D05744Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049095Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f660269-f83d-4f71-9a70-e2ddb2c57ec6Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
66977-032-082024-05-19MP00032 MPM Antiseptic Wound & Skin Cleanser 8 fl.oz
66977-032-082024-01-30MP00032 MPM Antiseptic Wound & Skin Cleanser 8 fl.oz
66977-032-022022-03-10MP00032 MPM Antiseptic Wound & Skin Cleanser 8 fl.oz
66977-032-082022-03-10MP00032 MPM Antiseptic Wound & Skin Cleanser 8 fl.oz
66977-032-022019-11-27MP00032 MPM Antiseptic Wound & Skin Cleanser 8 fl.oz
66977-032-082019-11-27MP00032 MPM Antiseptic Wound & Skin Cleanser 8 fl.oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66977-032-08Antiseptic237 mL in 1 BOTTLESOLUTION2374

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66977-032-02ML - Milliliter66977-0326000ff1d-42c8-40d1-8ca9-8a2c34d394e512015-10-02
66977-032-08ML - Milliliter66977-032a4674886-b7b6-4200-bab1-98bfdfa8269812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D05744ANTISEPTIC (BENZETHONIUM CHLORIDE) SOLUTION [MPM MEDICAL, INC.]1
BENZETHONIUMACTIVE MOIETY1VU15B70BPANTISEPTIC (BENZETHONIUM CHLORIDE) SOLUTION [MPM MEDICAL, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KANTISEPTIC (BENZETHONIUM CHLORIDE) SOLUTION [MPM MEDICAL, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXANTISEPTIC (BENZETHONIUM CHLORIDE) SOLUTION [MPM MEDICAL, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TANTISEPTIC (BENZETHONIUM CHLORIDE) SOLUTION [MPM MEDICAL, INC.]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNANTISEPTIC (BENZETHONIUM CHLORIDE) SOLUTION [MPM MEDICAL, INC.]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGANTISEPTIC (BENZETHONIUM CHLORIDE) SOLUTION [MPM MEDICAL, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IANTISEPTIC (BENZETHONIUM CHLORIDE) SOLUTION [MPM MEDICAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RANTISEPTIC (BENZETHONIUM CHLORIDE) SOLUTION [MPM MEDICAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66977-032ANTISEPTIC (BENZETHONIUM CHLORIDE) SOLUTION [MPM MEDICAL, LLC]3Current NDC, Legacy NDC, 1 package rows20240521_3f660269-f83d-4f71-9a70-e2ddb2c57ec6.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 97 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol sterileISOPROPYL ALCOHOLCardinal Health, Incbb7c530f-5d80-4158-b715-09c1c837299d2024-11-21WarningsExact identifier
application number: M003
Alcohol sterileISOPROPYL ALCOHOLCardinal Health 200 LLC10135db9-f614-4511-96ac-faa6a02a1b612024-11-21WarningsExact identifier
application number: M003
BZK Antiseptic Swabsticks 4 TripleBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltdd9f35c14-2f5a-4e1a-bc2b-a7e1631342132024-11-21WarningsExact identifier
application number: M003
Povidone-lodine Swabsticks TriplePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd74e70ea9-640b-4295-a40f-56f65fca13002024-11-21WarningsExact identifier
application number: M003
MK Alcohol Prep Pads MediumISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd37f10b1f-b73c-4d71-91c2-1252f3d9d4ce2024-11-21WarningsExact identifier
application number: M003
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd1936d749-bf38-a433-e063-6294a90aba8c2024-11-21WarningsExact identifier
application number: M003
Maokang 10 Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd7c17ce40-0358-44ff-aa60-53711666914b2024-11-21WarningsExact identifier
application number: M003
MK Alcohol Prep Pads MediumISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd11390854-9e72-40a2-9c89-3c29a585dced2024-11-21WarningsExact identifier
application number: M003
Instant Hand Sanitizeing WipeISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTSShandong Yayun Sanitary Products Co., Ltd.aa0dc01a-2c6b-7402-e053-2a95a90af6a22024-11-21WarningsExact identifier
application number: M003
Dynarex Povidone Iodine Prep SolutionPOVIDONE IODINE PREP SOLUTIONDynarex Corporation6bb4d55b-2be7-3549-e053-2a91aa0a2bb02024-11-20WarningsExact identifier
application number: M003
Dynarex Povidone Iodine Surgical ScrubPOVIDONE IODINE SURGICAL SCRUB SOLUTIONDynarex Corporation6f053e55-cbf6-9072-e053-2991aa0a2edd2024-11-20WarningsExact identifier
application number: M003
Dynarex GreenALCOHOLDynarex Corporation072572be-49dd-4594-bc40-b56db57ada5b2024-11-20WarningsExact identifier
application number: M003
Dynarex GreenCHLOROXYLENOLDynarex Corporation59b098d2-08de-4fdb-a209-ae226abf37d62024-11-20WarningsExact identifier
application number: M003
Baby WipesPROPYLENE GLYCOLShandong Yayun Sanitary Products Co., Ltd.aeb9a12c-955f-5030-e053-2995a90a2dd62024-11-20WarningsExact identifier
application number: M003
Pet wipesBENZALKONIUM CHLORIDEShandong Yayun Sanitary Products Co., Ltd.2764ea79-32d8-b7f6-e063-6394a90a55012024-11-20WarningsExact identifier
application number: M003
Premium Hand SanitizerETHANOLMCKESSON MEDICAL-SURGICAL INC.a9514466-e0c6-4792-984a-9f07d94ee8872024-11-18WarningsExact identifier
application number: M003
MARVEL BZK ANTISEPTIC WIPEBENZALKONIUM CHLORIDEAshtel Studios, Inc.93ed0bb4-834d-44ca-9c0a-20086fc09ab82024-11-18WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMcKesson Medical-Surgical Inc.98b0bcc2-539b-4471-ba98-bbe17bb881bd2024-11-15WarningsExact identifier
application number: M003
CVS Health Hydrogen Peroxide WipesHYDROGEN PEROXIDECVS PHARMACY, INC7a930a5e-5b69-428f-9cbb-d03dae1802952024-11-12WarningsExact identifier
application number: M003
First Aid Only Povidone-Iodine Prep PadPOVIDONE-IODINEAcme United Corporation509b6c8e-6a9f-2656-e054-00144ff8d46c2024-11-09WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049095benzethonium chloride 0.1 % Topical SprayPSN3f660269-f83d-4f71-9a70-e2ddb2c57ec64
1049095benzethonium chloride 1 MG/ML Topical SpraySCD3f660269-f83d-4f71-9a70-e2ddb2c57ec64
1049095benzethonium chloride 0.1 % Topical SpraySY3f660269-f83d-4f71-9a70-e2ddb2c57ec64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66977-032-0866977003208237 mL in 1 BOTTLE (66977-032-08) 237 ml1997-06-010000-00-00NoNoCurrent