Home NDC 17518-080-01 3M SoluPrep
Product NDC 17518-080
Requested package NDC 17518-080-01
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…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-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 · 41 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 2026-02-19 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208288-001 SOLUPREP 2%;70% SOLUTION / TOPICAL RLD, RS 2018-08-08 cb3db0bc1861…
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# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 17518-080-01 17518008001 1 APPLICATOR in 1 POUCH (17518-080-01) > 26 mL in 1 APPLICATOR 1 applicator 2018-10-08 0000-00-00 No No Current