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 90 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betadine SolutionPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.41891599-420e-48d2-8e31-d28a2209e3832025-01-06WarningsExact identifier
application number: M003
Signature Care Alcohol Prep PadISOPROPYL ALCOHOLBetter Living Brands LLCadc87331-1aa1-3457-e053-2a95a90a7eb12025-01-03WarningsExact identifier
application number: M003
Alcohol Extra-ThickISOPROPYL ALCOHOLMeijer Distribution Inc0b02643d-ea14-4877-ae9c-f0749d1b2d102025-01-03WarningsExact identifier
application number: M003
Premier ValueISOPROPYL ALCOHOLPharmacy Value Alliance, LLCd2baa47e-9673-7f23-e053-2a95a90adcb72025-01-03WarningsExact identifier
application number: M003
CVS Alcohol PrepISOPROPYL ALCOHOLCVS Pharmacy88f761c1-cb50-4edc-9a54-43444378eff72025-01-03WarningsExact identifier
application number: M003
Sterile AlcoholISOPROPYL ALCOHOLChain Drug Marketing Association Inc55922632-3768-4450-9389-ba7d7d91f2c92025-01-03WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCASAD Company, Inc1e314157-c64e-492a-89ad-2b28831d551d2025-01-03WarningsExact identifier
application number: M003
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.00002127-02bc-4c66-b0c3-ca29d8224afc2025-01-02WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON CANDYALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d02e4d6-8751-b5bc-e063-6394a90a9d972025-01-01WarningsExact identifier
application number: M003
COVISIDE HAND SANITIZERISOPROPYL ALCOHOLCREAGEN INCa9f07fcd-4d5c-362c-e053-2a95a90a2e792024-12-30WarningsExact identifier
application number: M003
KEEPAN ABENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.a30679d5-5507-499d-9d9f-498095fd32ac2024-12-30WarningsExact identifier
application number: M003
DE LA CRUZ GENTIAN VIOLETGENTIAN VIOLETDLC Laboratories, Inc.d7b4ca59-1bc3-4540-bc0a-2f4b7495a0a72024-12-30WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLR&C Imports LLC4e3fe418-d1d9-3024-e054-00144ff88e882024-12-27WarningsExact identifier
application number: M003
terrasil First Aid Antiseptic Wound and Burn CareHEXYLRESORCINOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2a2d81c9-5a9f-bb72-e063-6294a90aaf182024-12-26WarningsExact identifier
application number: M003
ABOVE INTIMATE LIQUIDSOAPABOVE INTIMATEBASTON INDUSTRIA DE AEROSSOIS LTDA02f37e55-72fb-532b-e063-6394a90ab0c32024-12-26WarningsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMMY IMPORTS USA LLC2a23da19-aca0-6d86-e063-6394a90ad52e2024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOLETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.2a23ed29-20c3-ab51-e063-6394a90a13a22024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOLETHYL ALCOHOLMY IMPORTS USA LLC2a24bfc4-cf6e-29a4-e063-6394a90afa782024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMZhejiang Guoyao Jingyue Aerosol Co., Ltd.29ff1d68-06f7-e133-e063-6294a90a61542024-12-24WarningsExact identifier
application number: M003
MedBox Hand SanitizerALCOHOLHarpers Pharmacy, Inc.f66c6abe-161c-48fa-8736-0abf97c3799a2024-12-20WarningsExact 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