FDA.reportPublic FDA data

3M SoluPrep S

Product NDC
17518-083
11-digit product format
175180083
Labeler code
17518
Product ID
17518-083_dc639f31-0e60-42dc-ab1c-e1f114c28a7a
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorhexidine Gluconate and Isopropyl Alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Solventum US LLC
Application
NDA208288
Marketing category
NDA
Marketing start
2023-01-23
Substance
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Active strength
20; .7 mg/mL; mL/mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
3M SoluPrep S
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE20 mg/mL
ISOPROPYL ALCOHOL.7 mL/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiND2M416302, MOR84MUD8E
Rxcui858726, 2629724

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17518-083-023M SoluPrep S10.5 mL in 1 APPLICATORSOLUTION10.55
17518-083-023M SoluPrep S1 in 1 POUCHSOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17518-0833M SOLUPREP S (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [SOLVENTUM US LLC]4Current NDC, 2 package rows20240808_084aa305-5863-441a-a94d-36bc1b05195a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858726chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical SolutionPSN084aa305-5863-441a-a94d-36bc1b05195a5
2629724SoluPrep 2 % / 70 % Topical SolutionPSN084aa305-5863-441a-a94d-36bc1b05195a5
2629724chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical Solution [Soluprep]SBD084aa305-5863-441a-a94d-36bc1b05195a5
858726chlorhexidine gluconate 20 MG/ML / isopropyl alcohol 0.7 ML/ML Topical SolutionSCD084aa305-5863-441a-a94d-36bc1b05195a5
858726chlorhexidine gluconate 2 % / isopropyl alcohol 70 % Topical SolutionSY084aa305-5863-441a-a94d-36bc1b05195a5
2629724SoluPrep (chlorhexidine gluconate 2 % / isopropyl alcohol 70 % ) Topical SolutionSY084aa305-5863-441a-a94d-36bc1b05195a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17518-083-02175180083021 APPLICATOR in 1 POUCH (17518-083-02) / 10.5 mL in 1 APPLICATOR1 applicator2023-01-23NoNoCurrent