FDA.reportPublic FDA data

3M SoluPrep S

Product NDC
17518-082
11-digit product format
175180082
Labeler code
17518
Product ID
17518-082_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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208288-001SOLUPREP SCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL2%;70%SOLUTION / TOPICALRLD, RS2018-08-08

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N208288-001M-2922026-01-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-08a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N208288-001M-2922026-01-20a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3M SoluPrep SCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLSolventum US LLC084aa305-5863-441a-a94d-36bc1b05195a2026-04-23WarningsExact identifier
application applno (NDA): 208288
application number: NDA208288
ndc (product): 17518-082

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ND2M416302Internal UNII lookup
MOR84MUD8EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
858726Internal RxNorm lookup
2629724Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
084aa305-5863-441a-a94d-36bc1b05195aAvailable on FDA.report

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
17518-082-013M SoluPrep S26 mL in 1 APPLICATORSOLUTION265
17518-082-013M SoluPrep S1 in 1 POUCHSOLUTION15
17518-082-023M SoluPrep S10.5 mL in 1 APPLICATORSOLUTION10.55
17518-082-023M SoluPrep S1 in 1 POUCHSOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17518-0823M SOLUPREP S (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [SOLVENTUM US LLC]4Current NDC, 4 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
17518-082-01175180082011 APPLICATOR in 1 POUCH (17518-082-01) / 26 mL in 1 APPLICATOR1 applicator2023-01-23NoNoCurrent
17518-082-02175180082021 APPLICATOR in 1 POUCH (17518-082-02) / 10.5 mL in 1 APPLICATOR1 applicator2023-01-23NoNoCurrent