Chlorhexidine Gluconate Oral Rinse
- Product NDC
- 68071-3630
- 11-digit product format
- 680713630
- Labeler code
- 68071
- Product ID
- 68071-3630_1b1ca163-8860-2b1c-e063-6294a90a1572
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Chlorhexidine Gluconate Oral Rinse
- Dosage form
- SOLUTION
- Route
- DENTAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA075561
- Marketing category
- ANDA
- Marketing start
- 2023-07-27
- Substance
- CHLORHEXIDINE GLUCONATE
- Active strength
- 1.2 mg/mL
- Pharmacologic classes
- Decreased Cell Wall Integrity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075561-001 | CHLORHEXIDINE GLUCONATE | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075561-001 | AT |
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 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | 2000-11-14 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | 2000-11-14 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | 2000-11-14 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | 2000-11-14 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | 2000-11-14 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | 2000-11-14 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | 2000-11-14 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075561-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2000-11-14 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075561-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075561-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075561-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075561-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075561-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075561-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075561-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075561-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075561-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075561-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075561-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075561-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075561-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075561-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075561-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075561-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075561-001 | AT | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A075561-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A075561-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075561-001 | AT | 1 | 87673890dc5c… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075561-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A075561-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A075561-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075561-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075561-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075561-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075561-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A075561-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A075561-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075561-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A075561-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A075561-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075561-001 | AT | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A075561-001 | AT | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| CleanCare Chlorhexidine Gluconate 0.12% Oral Rinse | CHLORHEXIDINE GLUCONATE | Safco Dental Supply LLC | 0d950be9-9d25-202c-e063-6294a90ada7d | 2026-03-02 | Warnings, Adverse reactions | 075561 ANDA075561 |
| CleanCare Chlorhexidine Gluconate 0.12% Oral Rinse | CHLORHEXIDINE GLUCONATE | Safco Dental Supply LLC | 0d9624f6-2a0b-c30f-e063-6294a90ae717 | 2026-03-02 | Warnings, Adverse reactions | 075561 ANDA075561 |
| Chlorhexidine Gluconate Oral Rinse | CHLORHEXIDINE GLUCONATE ORAL RINSE | Rising Pharma Holdings, Inc. | b6b45b87-aa53-4d3a-be59-f3d3b0774a7b | 2026-01-16 | Warnings, Adverse reactions | 075561 ANDA075561 |
| Chlorhexidine Gluconate, 0.12% Oral Rinse | CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE | American Health Packaging | 21002357-1780-4a5d-ad54-9936f4a9c031 | 2025-03-20 | Warnings, Adverse reactions | 075561 ANDA075561 |
| Chlorhexidine Gluconate Oral Rinse | CHLORHEXIDINE GLUCONATE ORAL RINSE | Brisk Pharmaceuticals | 2dcc3920-d9ed-bd56-e063-6294a90a0f3e | 2025-02-10 | Warnings, Adverse reactions | 075561 ANDA075561 |
| Chlorhexidine Gluconate, 0.12% Oral Rinse Solution | CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE | Kesin Pharma Corporation | 326c15fc-90d8-48de-abd0-61e0c4165529 | 2025-02-07 | Warnings, Adverse reactions | 075561 ANDA075561 |
| Chlorhexidine Gluconate, 0.12% Oral Rinse Solution | CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE | A2A Integrated Pharmaceuticals, LLC | 27d81483-e58c-593d-e063-6394a90a0db4 | 2025-01-10 | Warnings, Adverse reactions | 075561 ANDA075561 |
| Chlorhexidine Gluconate Oral Rinse | CHLORHEXIDINE GLUCONATE ORAL RINSE | NuCare Pharmaceuticals,Inc. | 1b1c9dc5-bd3d-d611-e063-6294a90a245d | 2024-06-17 | Warnings, Adverse reactions | 075561 ANDA075561 68071-3630 |
| Chlorhexidine Gluconate, 0.12% Oral Rinse Solution | CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE SOLUTION | Bajaj Medical, LLC | d44f4e79-e684-a1ef-e053-2995a90a4620 | 2024-01-02 | Warnings, Adverse reactions | 075561 ANDA075561 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Chlorhexidine Gluconate Oral Rinse
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CHLORHEXIDINE GLUCONATE | 1.2 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| MOR84MUD8E | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 834127 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1b1c9dc5-bd3d-d611-e063-6294a90a245d | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-3630-6 | Chlorhexidine Gluconate Oral Rinse | 473 mL in 1 BOTTLE | SOLUTION | 473 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-3630 | CHLORHEXIDINE GLUCONATE ORAL RINSE SOLUTION [NUCARE PHARMACEUTICALS,INC.] | 1 | Current NDC, 1 package rows | 20240619_1b1c9dc5-bd3d-d611-e063-6294a90a245d.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 834127 | chlorhexidine gluconate 0.12 % Oral Rinse | PSN | 1b1c9dc5-bd3d-d611-e063-6294a90a245d | 1 |
| 834127 | chlorhexidine gluconate 1.2 MG/ML Mouthwash | SCD | 1b1c9dc5-bd3d-d611-e063-6294a90a245d | 1 |
| 834127 | chlorhexidine gluconate 0.12 % Mouthwash | SY | 1b1c9dc5-bd3d-d611-e063-6294a90a245d | 1 |
| 834127 | chlorhexidine gluconate 0.12 % Oral Rinse | SY | 1b1c9dc5-bd3d-d611-e063-6294a90a245d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-3630-6 | 68071363006 | 473 mL in 1 BOTTLE (68071-3630-6) | 473 ml | 2024-06-17 | No | No | Current |