Prevantics swabstick
- Product NDC
- 10819-4075
- Requested package NDC
- 10819-4075-2
- 11-digit product format
- 108194075
- Labeler code
- 10819
- Product ID
- 10819-4075_96375545-612c-e27d-e053-2995a90a59d6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- chlorhexidine gluconate and isopropyl alcohol
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Professional Disposables International, Inc.
- Application
- NDA021524
- Marketing category
- NDA
- Marketing start
- 2013-01-15
- Marketing end
- 2022-12-31
- Substance
- CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
- Active strength
- 32 mg/mL; mL/mL
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 package | package | 10819-4075 | 10819-4075-2 | D | Discontinued by firm | 2026-09-14 |
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 | 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… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021524-001 | PREVANTICS SWAB | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 3.15%;70% (1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | |
| N021524-002 | PREVANTICS SWABSTICK | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 3.15%;70% (1.6ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | |
| N021524-003 | PREVANTICS MAXI SWABSTICK | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | 3.15%;70% (5.1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021524-001 | PREVANTICS SWAB | 3.15%;70% (1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021524-002 | PREVANTICS SWABSTICK | 3.15%;70% (1.6ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021524-003 | PREVANTICS MAXI SWABSTICK | 3.15%;70% (5.1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021524-001 | PREVANTICS SWAB | 3.15%;70% (1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021524-002 | PREVANTICS SWABSTICK | 3.15%;70% (1.6ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021524-003 | PREVANTICS MAXI SWABSTICK | 3.15%;70% (5.1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021524-001 | PREVANTICS SWAB | 3.15%;70% (1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021524-002 | PREVANTICS SWABSTICK | 3.15%;70% (1.6ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021524-003 | PREVANTICS MAXI SWABSTICK | 3.15%;70% (5.1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021524-001 | PREVANTICS SWAB | 3.15%;70% (1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021524-002 | PREVANTICS SWABSTICK | 3.15%;70% (1.6ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021524-003 | PREVANTICS MAXI SWABSTICK | 3.15%;70% (5.1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021524-001 | PREVANTICS SWAB | 3.15%;70% (1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021524-002 | PREVANTICS SWABSTICK | 3.15%;70% (1.6ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021524-003 | PREVANTICS MAXI SWABSTICK | 3.15%;70% (5.1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021524-001 | PREVANTICS SWAB | 3.15%;70% (1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021524-002 | PREVANTICS SWABSTICK | 3.15%;70% (1.6ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021524-003 | PREVANTICS MAXI SWABSTICK | 3.15%;70% (5.1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021524-001 | PREVANTICS SWAB | 3.15%;70% (1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021524-002 | PREVANTICS SWABSTICK | 3.15%;70% (1.6ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021524-003 | PREVANTICS MAXI SWABSTICK | 3.15%;70% (5.1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021524-001 | PREVANTICS SWAB | 3.15%;70% (1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021524-002 | PREVANTICS SWABSTICK | 3.15%;70% (1.6ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021524-003 | PREVANTICS MAXI SWABSTICK | 3.15%;70% (5.1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021524-001 | PREVANTICS SWAB | 3.15%;70% (1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021524-002 | PREVANTICS SWABSTICK | 3.15%;70% (1.6ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021524-003 | PREVANTICS MAXI SWABSTICK | 3.15%;70% (5.1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021524-001 | PREVANTICS SWAB | 3.15%;70% (1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021524-002 | PREVANTICS SWABSTICK | 3.15%;70% (1.6ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021524-003 | PREVANTICS MAXI SWABSTICK | 3.15%;70% (5.1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021524-001 | PREVANTICS SWAB | 3.15%;70% (1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021524-002 | PREVANTICS SWABSTICK | 3.15%;70% (1.6ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021524-003 | PREVANTICS MAXI SWABSTICK | 3.15%;70% (5.1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021524-001 | PREVANTICS SWAB | 3.15%;70% (1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021524-002 | PREVANTICS SWABSTICK | 3.15%;70% (1.6ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021524-003 | PREVANTICS MAXI SWABSTICK | 3.15%;70% (5.1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021524-001 | PREVANTICS SWAB | 3.15%;70% (1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021524-002 | PREVANTICS SWABSTICK | 3.15%;70% (1.6ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021524-003 | PREVANTICS MAXI SWABSTICK | 3.15%;70% (5.1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021524-001 | PREVANTICS SWAB | 3.15%;70% (1ML) | SWAB / TOPICAL | RLD, RS | 2005-06-03 | 301d65b070ca… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021524-001 | M-221 | 2021-02-14 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021524-002 | M-221 | 2021-02-14 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021524-003 | M-221 | 2021-02-14 | 74a2ff9319b5… |
| 2021-12-28 21:50 UTC | 2021-12 | N021524-001 | M-221 | 2021-02-14 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021524-002 | M-221 | 2021-02-14 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021524-003 | M-221 | 2021-02-14 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021524-001 | M-221 | 2021-02-14 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021524-002 | M-221 | 2021-02-14 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021524-003 | M-221 | 2021-02-14 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021524-001 | M-221 | 2021-02-14 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021524-002 | M-221 | 2021-02-14 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021524-003 | M-221 | 2021-02-14 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021524-001 | M-221 | 2021-02-14 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021524-002 | M-221 | 2021-02-14 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021524-003 | M-221 | 2021-02-14 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021524-001 | M-221 | 2021-02-14 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021524-002 | M-221 | 2021-02-14 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021524-003 | M-221 | 2021-02-14 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021524-001 | M-221 | 2021-02-14 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021524-002 | M-221 | 2021-02-14 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021524-003 | M-221 | 2021-02-14 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021524-001 | M-221 | 2021-02-14 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021524-002 | M-221 | 2021-02-14 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021524-003 | M-221 | 2021-02-14 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021524-001 | M-221 | 2021-02-14 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021524-002 | M-221 | 2021-02-14 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021524-003 | M-221 | 2021-02-14 | ea99ee380514… |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Prevantics Swabstick | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | Professional Disposables International, Inc. | 9841200b-d4c6-b40c-e053-2995a90a5596 | 2025-02-10 | Warnings | 021524 NDA021524 |
| Prevantics Swab | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | Professional Disposables International, Inc. | ff999b50-0b6b-404e-b4f1-c6694fe47a9b | 2023-10-13 | Warnings | 021524 NDA021524 |
| Prevantics Swab | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | Professional Disposables International, Inc. | db61e7fd-c421-4e3c-bc88-0343230273de | 2023-10-13 | Warnings | 021524 NDA021524 |
| Prevantics Maxi Swabstick | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | Professional Disposables International, Inc. | 93ca3c07-40b4-3a91-e053-2995a90a0afd | 2023-06-30 | Warnings | 021524 NDA021524 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 10819-4075-2 | 10819407502 | 500 POUCH in 1 CASE (10819-4075-2) > 1.6 mL in 1 POUCH | 500 pouch | 2013-01-15 | 2022-12-31 | No | No | Current |