Denti-Care Denti-Rinse
- Product NDC
- 0116-0244
- 11-digit product format
- 001160244
- Labeler code
- 0116
- Product ID
- 0116-0244_b17d2149-2713-07f7-e053-2995a90a8fba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Chlorhexidine Gluconante
- Dosage form
- LIQUID
- Route
- DENTAL
- Labeler
- Xttrium Laboratories, Inc.
- Application
- ANDA077789
- Marketing category
- ANDA
- Marketing start
- 2006-06-02
- Marketing end
- 0000-00-00
- Substance
- CHLORHEXIDINE GLUCONATE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Decreased Cell Wall Integrity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0116-0244 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 0116-0244 | 0116-0244-01 | D | Discontinued by firm | 2026-08-17 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077789-001 | CHLORHEXIDINE GLUCONATE | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077789-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A077789-001 | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION / DENTAL | AT | 2009-06-18 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077789-001 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077789-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077789-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077789-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077789-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077789-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077789-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077789-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077789-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077789-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077789-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077789-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077789-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077789-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077789-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077789-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077789-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077789-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077789-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077789-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077789-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077789-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A077789-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077789-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077789-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077789-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077789-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077789-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077789-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A077789-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A077789-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077789-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077789-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077789-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077789-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A077789-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A077789-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077789-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A077789-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A077789-001 | AT | 1 | e64feba35796… |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Major Oral Rinse | 0.12% CHLORHEXIDINE GLUCONATE | Cardinal Health 107, LLC | baad6ebb-ba44-4abe-8882-f2391d17d816 | 2026-05-29 | Warnings, Adverse reactions | 077789 ANDA077789 |
| Major Oral Rinse | 0.12% CHLORHEXIDINE GLUCONATE | Cardinal Health 107, LLC | 772889a1-fc68-4400-9612-6fa51d0b6878 | 2026-05-11 | Warnings, Adverse reactions | 077789 ANDA077789 |
| Acclean Chlorhexidine Gluconate 0.12% Oral Rinse | CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE | Henry Schein, Inc. | 0829509a-1b9b-5d8a-e054-00144ff8d46c | 2026-04-30 | Warnings, Adverse reactions | 077789 ANDA077789 |
| Chlorhexidine Gluconate | CHLORHEXIDINE GLUCONATE | Major Pharmaceuticals | b48e69dc-0913-423f-e053-2a95a90a53df | 2026-04-29 | Warnings, Adverse reactions | 077789 ANDA077789 |
| Chlorhexidine Gluconate | CHLORHEXIDINE GLUCONATE | Benco Dental | 21b03b2a-44ee-41c0-e054-00144ff8d46c | 2026-04-29 | Warnings, Adverse reactions | 077789 ANDA077789 |
| Chlorhexidine Gluconate | CHLORHEXIDINE GLUCONATE | Xttrium Laboratories, Inc. | 4a3a4cfe-88e0-0a10-e054-00144ff88e88 | 2026-04-27 | Warnings, Adverse reactions | 077789 ANDA077789 |
| Chlorhexidine Gluconate | CHLORHEXIDINE GLUCONATE | Xttrium Laboratories, Inc. | 4a3a684f-5f72-347a-e054-00144ff8d46c | 2026-04-27 | Warnings, Adverse reactions | 077789 ANDA077789 |
| Chlorhexidine Gluconate | CHLORHEXIDINE GLUCONATE | Preferred Pharmaceuticals, Inc. | 1c3401ef-6a7a-485e-ab7e-52420a36f4e2 | 2026-03-27 | Warnings, Adverse reactions | 077789 ANDA077789 |
| Chlorhexidine Gluconate 0.12% Oral Rinse | CHLORHEXIDINE GLUCONATE | Sage Products LLC | 3c754532-d9a5-f876-00c4-05a4c9b21efa | 2025-10-21 | Warnings, Adverse reactions | 077789 ANDA077789 |
| Chlorhexidine Gluconate | CHLORHEXIDINE GLUCONATE | Medline Industries, LP | 92eddf00-7e23-4d5b-b5cd-38af99ad9e56 | 2025-10-13 | Warnings, Adverse reactions | 077789 ANDA077789 |
| Chlorhexidine Gluconate | CHLORHEXIDINE GLUCONATE | REMEDYREPACK INC. | 7e3862b9-3786-4cfe-bfad-c992a7038eca | 2025-10-08 | Warnings, Adverse reactions | 077789 ANDA077789 |
| Chlorhexidine Gluconate | CHLORHEXIDINE GLUCONATE | Xttrium Laboratories, Inc. | 4a2c3c98-4e4e-1c9b-e054-00144ff88e88 | 2025-05-28 | Warnings, Adverse reactions | 077789 ANDA077789 |
| Acclean Chlorhexidine Gluconate 0.12% Oral Rinse | CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE | Xttrium Laboratories, Inc. | 4a2a6bb8-85b0-6c36-e054-00144ff8d46c | 2025-05-28 | Warnings, Adverse reactions | 077789 ANDA077789 |
| Chlorhexidine Gluconate | CHLORHEXIDINE GLUCONATE | ATLANTIC BIOLOGICALS CORP. | ec1c2a9f-f0e3-c560-360a-2d2cbdd0cb7c | 2025-05-12 | Warnings, Adverse reactions | 077789 ANDA077789 |
| Chlorhexidine Gluconate | CHLORHEXIDINE GLUCONATE | Atlantic Biologicals Corps. | b445d769-a9e3-f72a-fbab-d485457996d0 | 2025-05-12 | Warnings, Adverse reactions | 077789 ANDA077789 |
| NUPRO Chlorhexidine Gluconate | CHLORHEXIDINE GLUCONATE | Xttrium Laboratories, Inc. | 4a3b87bc-d913-6c88-e054-00144ff8d46c | 2025-04-30 | Warnings, Adverse reactions | 077789 ANDA077789 |
| Acclean Chlorhexidine Gluconate 0.12% Oral Rinse | CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE | Xttrium Laboratories, Inc. | 4a2bd280-918d-0e26-e054-00144ff88e88 | 2025-04-30 | Warnings, Adverse reactions | 077789 ANDA077789 |
| Chlorhexidine Gluconate | CHLORHEXIDINE GLUCONATE | NuCare Pharmaceuticals,Inc. | 56e5e687-b1b5-6b43-e054-00144ff88e88 | 2024-12-31 | Warnings, Adverse reactions | 077789 ANDA077789 |
| NUPRO Chlorhexidine Gluconate | CHLORHEXIDINE GLUCONATE | Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" | d9d25abd-c3b4-4713-91c7-538f98e8fb70 | 2024-12-24 | Warnings, Adverse reactions | 077789 ANDA077789 |
| Chlorhexidine Gluconate | CHLORHEXIDINE GLUCONATE | A-S Medication Solutions | b589dcb9-883a-4f80-8f66-7a6c2051bf2a | 2024-06-10 | Warnings, Adverse reactions | 077789 ANDA077789 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0116-0244-01 | 00116024401 | 473 mL in 1 BOTTLE, PLASTIC (0116-0244-01) | 473 ml | 2006-06-02 | 0000-00-00 | No | No | Current |