Hibiclens
- Product NDC
- 0234-0575
- Requested package NDC
- 0234-0575-17
- 11-digit product format
- 002340575
- Labeler code
- 0234
- Product ID
- 0234-0575_29f35571-d7a5-b30f-e063-6394a90aca88
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Chlorhexidine Gluconate
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Molnlycke Health Care
- Application
- NDA017768
- Marketing category
- NDA
- Marketing start
- 2016-02-15
- Substance
- CHLORHEXIDINE GLUCONATE
- Active strength
- 4 g/100mL
- Pharmacologic classes
- Decreased Cell Wall Integrity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 0234-0575 | 0234-0575-17 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 0234-0575 | 0234-0575-17 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 0234-0575 | 0234-0575-17 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017768-001 | HIBICLENS | CHLORHEXIDINE GLUCONATE | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 |
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 | 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 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N017768-001 | HIBICLENS | 4% | SOLUTION / TOPICAL | RLD, RS, Approved before 1982 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hibiclens
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CHLORHEXIDINE GLUCONATE | 4 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| MOR84MUD8E | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 29b547bf-c08e-14c2-e054-00144ff88e88 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| bb6d6c68-649d-4e6d-a1f6-603d969c8f68 | Product name | 1 | 20160303 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0234-0575-40 | Hibiclens | 118 mL in 1 BOTTLE | SOLUTION | 118 | 14 | |
| 0234-0575-41 | Hibiclens | 118 mL in 1 BOTTLE, PUMP | SOLUTION | 118 | 14 | |
| 0234-0575-80 | Hibiclens | 236 mL in 1 BOTTLE, PUMP | SOLUTION | 236 | 14 | |
| 0234-0575-04 | Hibiclens | 118 mL in 1 BOTTLE | SOLUTION | 118 | 13 | |
| 0234-0575-08 | Hibiclens | 236 mL in 1 BOTTLE | SOLUTION | 236 | 13 | |
| 0234-0575-16 | Hibiclens | 473 mL in 1 BOTTLE | SOLUTION | 473 | 13 | |
| 0234-0575-32 | Hibiclens | 946 mL in 1 BOTTLE | SOLUTION | 946 | 13 | |
| 0234-0575-91 | Hibiclens | 3790 mL in 1 BOTTLE | SOLUTION | 3790 | 13 | |
| 0234-0575-17 | Hibiclens | 50 in 1 CARTON | SOLUTION | 50 | 11 | |
| 0234-0575-17 | Hibiclens | 15 mL in 1 PACKET | SOLUTION | 15 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0234-0575-04 | ML - Milliliter | 0234-0575 | 2c7f09fc-94c5-4fc5-b48c-71188619df18 | 1 | 2012-07-24 |
| 0234-0575-08 | ML - Milliliter | 0234-0575 | 9eea668e-5fde-456f-a7ee-3251bffca1c5 | 1 | 2012-07-24 |
| 0234-0575-16 | ML - Milliliter | 0234-0575 | 0cc2b373-1d80-4637-99b6-75fb80ba95a2 | 1 | 2012-07-24 |
| 0234-0575-17 | ML - Milliliter | 0234-0575 | 94926e3b-31c8-456c-8dea-5c4ed2b69cdd | 1 | 2012-07-24 |
| 0234-0575-32 | ML - Milliliter | 0234-0575 | 588c6c29-dfd9-40e4-ba05-8544184bdfca | 1 | 2012-07-24 |
| 0234-0575-40 | ML - Milliliter | 0234-0575 | b49c8b95-df57-4aea-b30b-e4892191a037 | 1 | 2017-11-06 |
| 0234-0575-41 | ML - Milliliter | 0234-0575 | 2d7ae4b3-648f-4ab7-bb82-dca7abcd265c | 1 | 2019-12-10 |
| 0234-0575-80 | ML - Milliliter | 0234-0575 | d0508c6d-a36c-46d0-be06-7f8f2d689bb7 | 1 | 2026-04-20 |
| 0234-0575-91 | ML - Milliliter | 0234-0575 | 7ea5bf35-011c-4299-a7e2-29b0c6ecbb6e | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0234-0575 | HIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE] | 14 | Current NDC, Legacy NDC, 3 package rows | 20241225_29b547bf-c08e-14c2-e054-00144ff88e88.zip |
| 0234-0575 | HIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE] | 13 | Current NDC, Legacy NDC, 5 package rows | 20241225_4275eb53-1a7e-4a91-aac1-1085f40fac88.zip |
| 0234-0575 | HIBICLENS (CHLORHEXIDINE GLUCONATE) SOLUTION [MOLNLYCKE HEALTH CARE] | 11 | Current NDC, Legacy NDC, 2 package rows | 20241225_8b37a721-79bb-4051-95a7-fcb4edebfcb7.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hibiclens | CHLORHEXIDINE GLUCONATE | Molnlycke Health Care | 29b547bf-c08e-14c2-e054-00144ff88e88 | 2024-12-23 | Warnings | 017768 NDA017768 0234-0575 |
| Hibiclens | CHLORHEXIDINE GLUCONATE | Molnlycke Health Care | 4275eb53-1a7e-4a91-aac1-1085f40fac88 | 2024-12-23 | Warnings | 017768 NDA017768 0234-0575 |
| Hibiclens | CHLORHEXIDINE GLUCONATE | Molnlycke Health Care | 8b37a721-79bb-4051-95a7-fcb4edebfcb7 | 2024-12-23 | Warnings | 017768 NDA017768 0234-0575-17 0234-0575 00234057517 |
| Hibiclens | CHLORHEXIDINE GLUCONATE | Asclemed USA, Inc. | c7363108-0b4e-4d8a-9ec8-ea048604ecb2 | 2024-10-05 | Warnings | 017768 NDA017768 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 211365 | chlorhexidine gluconate 4 % Medicated Liquid Soap | PSN | 29b547bf-c08e-14c2-e054-00144ff88e88 | 14 |
| 834167 | HIBICLENS 4 % Medicated Liquid Soap | PSN | 29b547bf-c08e-14c2-e054-00144ff88e88 | 14 |
| 834167 | chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Hibiclens] | SBD | 29b547bf-c08e-14c2-e054-00144ff88e88 | 14 |
| 211365 | chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap | SCD | 29b547bf-c08e-14c2-e054-00144ff88e88 | 14 |
| 211365 | chlorhexidine gluconate 4 % Medicated Liquid Soap | SY | 29b547bf-c08e-14c2-e054-00144ff88e88 | 14 |
| 211365 | chlorhexidine gluconate 4 % Medicated Surgical Scrub | SY | 29b547bf-c08e-14c2-e054-00144ff88e88 | 14 |
| 834167 | Hibiclens 4 % Medicated Liquid Soap | SY | 29b547bf-c08e-14c2-e054-00144ff88e88 | 14 |
| 211365 | chlorhexidine gluconate 4 % Medicated Liquid Soap | PSN | 4275eb53-1a7e-4a91-aac1-1085f40fac88 | 13 |
| 834167 | HIBICLENS 4 % Medicated Liquid Soap | PSN | 4275eb53-1a7e-4a91-aac1-1085f40fac88 | 13 |
| 834167 | chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Hibiclens] | SBD | 4275eb53-1a7e-4a91-aac1-1085f40fac88 | 13 |
| 211365 | chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap | SCD | 4275eb53-1a7e-4a91-aac1-1085f40fac88 | 13 |
| 211365 | chlorhexidine gluconate 4 % Medicated Liquid Soap | SY | 4275eb53-1a7e-4a91-aac1-1085f40fac88 | 13 |
| 211365 | chlorhexidine gluconate 4 % Medicated Surgical Scrub | SY | 4275eb53-1a7e-4a91-aac1-1085f40fac88 | 13 |
| 834167 | Hibiclens 4 % Medicated Liquid Soap | SY | 4275eb53-1a7e-4a91-aac1-1085f40fac88 | 13 |
| 211365 | chlorhexidine gluconate 4 % Medicated Liquid Soap | PSN | 8b37a721-79bb-4051-95a7-fcb4edebfcb7 | 11 |
| 834167 | HIBICLENS 4 % Medicated Liquid Soap | PSN | 8b37a721-79bb-4051-95a7-fcb4edebfcb7 | 11 |
| 834167 | chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Hibiclens] | SBD | 8b37a721-79bb-4051-95a7-fcb4edebfcb7 | 11 |
| 211365 | chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap | SCD | 8b37a721-79bb-4051-95a7-fcb4edebfcb7 | 11 |
| 211365 | chlorhexidine gluconate 4 % Medicated Liquid Soap | SY | 8b37a721-79bb-4051-95a7-fcb4edebfcb7 | 11 |
| 211365 | chlorhexidine gluconate 4 % Medicated Surgical Scrub | SY | 8b37a721-79bb-4051-95a7-fcb4edebfcb7 | 11 |
| 834167 | Hibiclens 4 % Medicated Liquid Soap | SY | 8b37a721-79bb-4051-95a7-fcb4edebfcb7 | 11 |
| 211365 | chlorhexidine gluconate 4 % Medicated Liquid Soap | PSN | c7363108-0b4e-4d8a-9ec8-ea048604ecb2 | 3 |
| 834167 | HIBICLENS 4 % Medicated Liquid Soap | PSN | c7363108-0b4e-4d8a-9ec8-ea048604ecb2 | 3 |
| 834167 | chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Hibiclens] | SBD | c7363108-0b4e-4d8a-9ec8-ea048604ecb2 | 3 |
| 211365 | chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap | SCD | c7363108-0b4e-4d8a-9ec8-ea048604ecb2 | 3 |
| 211365 | chlorhexidine gluconate 4 % Medicated Liquid Soap | SY | c7363108-0b4e-4d8a-9ec8-ea048604ecb2 | 3 |
| 211365 | chlorhexidine gluconate 4 % Medicated Surgical Scrub | SY | c7363108-0b4e-4d8a-9ec8-ea048604ecb2 | 3 |
| 834167 | Hibiclens 4 % Medicated Liquid Soap | SY | c7363108-0b4e-4d8a-9ec8-ea048604ecb2 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0234-0575-17 | 00234057517 | 50 PACKET in 1 CARTON (0234-0575-17) / 15 mL in 1 PACKET | 50 packet | 1976-09-17 | 0000-00-00 | No | No | Current |