Home NDC 17518-083 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208288-001 SOLUPREP S CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208288-001 M-292 2026-01-20
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 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208288-001 SOLUPREP S 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 e64feba35796…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 ea99ee380514…2023-01-26 05:58 UTC 2023-01 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208288-001 8623935 2029-07-26 U-1022 Drug product 2018-09-06 cb3db0bc1861…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base 3M SoluPrep S
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORHEXIDINE GLUCONATE 20 mg/mL ISOPROPYL ALCOHOL .7 mL/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MOR84MUD8E Internal UNII lookup ND2M416302 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858726 Internal RxNorm lookup 2629724 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17518-083-02 3M SoluPrep S 10.5 mL in 1 APPLICATOR SOLUTION 10.5 5 17518-083-02 3M SoluPrep S 1 in 1 POUCH SOLUTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17518-083 3M SOLUPREP S (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [SOLVENTUM US LLC] 4 Current NDC, 2 package rows 20240808_084aa305-5863-441a-a94d-36bc1b05195a.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 17518-083-02 17518008302 1 APPLICATOR in 1 POUCH (17518-083-02) / 10.5 mL in 1 APPLICATOR 1 applicator 2023-01-23 No No Current