3M SoluPrep

Product NDC
17518-080
11-digit product format
175180080
Labeler code
17518
Product ID
17518-080_143b2b24-3df5-4e62-9212-a448f43744ef
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorhexidine Gluconate and Isopropyl Alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
3M Company
Application
NDA208288
Marketing category
NDA
Marketing start
2018-10-08
Marketing end
0000-00-00
Substance
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Active strength
20 mg/mL; mL/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17518-080DDiscontinued by firm2026-08-10
excluded packagepackage17518-08017518-080-01DDiscontinued by firm2026-08-10
excluded packagepackage17518-08017518-080-02DDiscontinued by firm2026-08-10

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17518-080-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17518-080-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17518-080-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17518-080-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17518-080-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17518-080-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17518-080-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17518-080-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17518-080-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17518-080-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17518-080-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17518-080-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17518-080-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17518-080-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17518-080-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17518-080-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17518-080-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17518-080-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17518-080-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17518-080-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17518-080-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17518-080-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17518-080-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17518-080-02557ba5c1ecfa…9c80585c8c6e…

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-083f01610625f2…
2019-09-15 20:21 UTC2019-09N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N208288-001SOLUPREP S2%;70%SOLUTION / TOPICALRLD, RS2018-08-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208288-001SOLUPREP2%;70%SOLUTION / TOPICALRLD, RS2018-08-08cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208288-00186239352029-07-26U-1022Drug product2018-09-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208288-00186239352029-07-26U-1022Drug product2018-09-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208288-00186239352029-07-26U-1022Drug product2018-09-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208288-00186239352029-07-26U-1022Drug product2018-09-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208288-00186239352029-07-26U-1022Drug product2018-09-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208288-00186239352029-07-26U-1022Drug product2018-09-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208288-00186239352029-07-26U-1022Drug product2018-09-0687673890dc5c…
2021-03-12 10:30 UTC2021-03N208288-00186239352029-07-26U-1022Drug product2018-09-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208288-00186239352029-07-26U-1022Drug product2018-09-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208288-00186239352029-07-26U-1022Drug product2018-09-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208288-00186239352029-07-26U-1022Drug product2018-09-063f01610625f2…
2019-09-15 20:21 UTC2019-09N208288-00186239352029-07-26U-1022Drug product2018-09-06b00525d2431f…
2019-07-19 19:46 UTC2019-07N208288-00186239352029-07-26U-1022Drug product2018-09-06ea99ee380514…
2023-01-26 05:58 UTC2023-01N208288-00186239352029-07-26U-1022Drug product2018-09-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208288-00186239352029-07-26U-1022Drug product2018-09-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208288-00186239352029-07-26U-1022Drug product2018-09-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208288-00186239352029-07-26U-1022Drug product2018-09-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208288-00186239352029-07-26U-1022Drug product2018-09-06cb3db0bc1861…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N208288-001M-2922026-01-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208288-001M-2922026-01-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N208288-001M-2922026-01-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208288-001M-2922026-01-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208288-001M-2922026-01-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208288-001M-2922026-01-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208288-001M-2922026-01-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208288-001M-2922026-01-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208288-001M-2922026-01-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208288-001M-2922026-01-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208288-001M-2922026-01-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208288-001M-2922026-01-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208288-001M-2922026-01-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208288-001M-2922026-01-208072bd15b7f6…
2019-12-13 00:20 UTC2019-12N208288-001NP2021-08-0874a2ff9319b5…
2021-12-28 21:50 UTC2021-12N208288-001NP2021-08-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208288-001NP2021-08-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N208288-001NP2021-08-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208288-001NP2021-08-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208288-001NP2021-08-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208288-001NP2021-08-083f01610625f2…
2019-09-15 20:21 UTC2019-09N208288-001NP2021-08-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N208288-001NP2021-08-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208288-001M-2922026-01-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208288-001M-2922026-01-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208288-001M-2922026-01-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208288-001M-2922026-01-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208288-001M-2922026-01-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208288-001M-2922026-01-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208288-001M-2922026-01-203f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N208288-001M-2922026-01-20a50c72e98297…

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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17518-080-01175180080011 APPLICATOR in 1 POUCH (17518-080-01) > 26 mL in 1 APPLICATOR1 applicator2018-10-080000-00-00NoNoCurrent
17518-080-02175180080021 APPLICATOR in 1 POUCH (17518-080-02) > 10.5 mL in 1 APPLICATOR1 applicator2018-10-080000-00-00NoNoCurrent