Prevantics Swab
- Product NDC
- 10819-1080
- 11-digit product format
- 108191080
- Labeler code
- 10819
- Product ID
- 10819-1080_078de79b-c16c-78f8-e063-6294a90a384a
- 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
- Substance
- CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
- Active strength
- 31.5; .7 mg/mL; mL/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 |
|---|---|---|---|---|---|---|---|
| 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… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Prevantics Swab
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CHLORHEXIDINE GLUCONATE | 31.5 mg/mL |
| ISOPROPYL ALCOHOL | .7 mL/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| MOR84MUD8E | Internal UNII lookup |
| ND2M416302 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ff999b50-0b6b-404e-b4f1-c6694fe47a9b | 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 |
|---|---|---|---|---|---|---|
| 10819-1080-1 | Prevantics Swab | 100 in 1 BOX | SOLUTION | 100 | 10 | |
| 10819-1080-1 | Prevantics Swab | 1 mL in 1 POUCH | SOLUTION | 1 | 10 | |
| 10819-1080-2 | Prevantics Swab | 1 mL in 1 POUCH | SOLUTION | 1 | 10 | |
| 10819-1080-2 | Prevantics Swab | 3000 in 1 CASE | SOLUTION | 3000 | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10819-1080 | PREVANTICS SWAB (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20231014_db61e7fd-c421-4e3c-bc88-0343230273de.zip |
| 10819-1080 | PREVANTICS SWAB (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20231014_ff999b50-0b6b-404e-b4f1-c6694fe47a9b.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 |
|---|---|---|---|---|---|---|
| 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 10819-1080 |
| Prevantics Swab | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | Professional Disposables International, Inc. | db61e7fd-c421-4e3c-bc88-0343230273de | 2023-10-13 | Warnings | 021524 NDA021524 10819-1080 |
| Prevantics Maxi Swabstick | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | Professional Disposables International, Inc. | 93ca3c07-40b4-3a91-e053-2995a90a0afd | 2023-06-30 | Warnings | 021524 NDA021524 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1191171 | chlorhexidine gluconate 3.15 % / Isopropyl Alcohol 70 % Medicated Pad | PSN | db61e7fd-c421-4e3c-bc88-0343230273de | 10 |
| 1191171 | chlorhexidine gluconate 3.15 % / Isopropyl Alcohol 70 % Medicated Pad | PSN | ff999b50-0b6b-404e-b4f1-c6694fe47a9b | 10 |
| 1366736 | Prevantics 3.15 % / 70 % Swabstick | PSN | db61e7fd-c421-4e3c-bc88-0343230273de | 10 |
| 1366736 | Prevantics 3.15 % / 70 % Swabstick | PSN | ff999b50-0b6b-404e-b4f1-c6694fe47a9b | 10 |
| 1366736 | chlorhexidine gluconate 31.5 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated Pad [Prevantics] | SBD | db61e7fd-c421-4e3c-bc88-0343230273de | 10 |
| 1366736 | chlorhexidine gluconate 31.5 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated Pad [Prevantics] | SBD | ff999b50-0b6b-404e-b4f1-c6694fe47a9b | 10 |
| 1191171 | chlorhexidine gluconate 31.5 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | db61e7fd-c421-4e3c-bc88-0343230273de | 10 |
| 1191171 | chlorhexidine gluconate 31.5 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | ff999b50-0b6b-404e-b4f1-c6694fe47a9b | 10 |
| 1366736 | Prevantics (chlorhexidine gluconate 3.15 % / isopropyl alcohol 70 % ) Swabstick | SY | db61e7fd-c421-4e3c-bc88-0343230273de | 10 |
| 1366736 | Prevantics (chlorhexidine gluconate 3.15 % / isopropyl alcohol 70 % ) Swabstick | SY | ff999b50-0b6b-404e-b4f1-c6694fe47a9b | 10 |
| 1366736 | Prevantics (chlorhexidine gluconate 31.5 MG/ML / isopropyl alcohol 0.7 ML/ML) Medicated Pad | SY | db61e7fd-c421-4e3c-bc88-0343230273de | 10 |
| 1366736 | Prevantics (chlorhexidine gluconate 31.5 MG/ML / isopropyl alcohol 0.7 ML/ML) Medicated Pad | SY | ff999b50-0b6b-404e-b4f1-c6694fe47a9b | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 10819-1080-1 | 10819108001 | 100 POUCH in 1 BOX (10819-1080-1) / 1 mL in 1 POUCH | 100 pouch | 2013-01-15 | 0000-00-00 | No | No | Current |
| 10819-1080-2 | 10819108002 | 3000 POUCH in 1 CASE (10819-1080-2) / 1 mL in 1 POUCH | 3000 pouch | 2013-01-15 | 0000-00-00 | No | No | Current |