Prevantics Swabstick

Product NDC
10819-4077
11-digit product format
108194077
Labeler code
10819
Product ID
10819-4077_2dced465-11bf-7823-e063-6394a90a9fac
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
2020-06-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021524-001PREVANTICS SWABCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-03
N021524-002PREVANTICS SWABSTICKCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-03
N021524-003PREVANTICS MAXI SWABSTICKCHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-03

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-0384e616aacf4f…
2026-09-14 22:38:342026-08N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-0384e616aacf4f…
2026-09-14 22:38:342026-08N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-0384e616aacf4f…
2026-08-18 06:07:402026-07N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021524-002PREVANTICS SWABSTICK3.15%;70% (1.6ML)SWAB / TOPICALRLD, RS2005-06-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021524-003PREVANTICS MAXI SWABSTICK3.15%;70% (5.1ML)SWAB / TOPICALRLD, RS2005-06-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021524-001PREVANTICS SWAB3.15%;70% (1ML)SWAB / TOPICALRLD, RS2005-06-03301d65b070ca…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N021524-001M-2212021-02-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021524-002M-2212021-02-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021524-003M-2212021-02-1474a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021524-001M-2212021-02-14782e0a99824c…
2021-12-28 21:50 UTC2021-12N021524-002M-2212021-02-14782e0a99824c…
2021-12-28 21:50 UTC2021-12N021524-003M-2212021-02-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021524-001M-2212021-02-1487673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021524-002M-2212021-02-1487673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021524-003M-2212021-02-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N021524-001M-2212021-02-145aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021524-002M-2212021-02-145aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021524-003M-2212021-02-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021524-001M-2212021-02-148869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021524-002M-2212021-02-148869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021524-003M-2212021-02-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021524-001M-2212021-02-14c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021524-002M-2212021-02-14c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021524-003M-2212021-02-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021524-001M-2212021-02-143f01610625f2…
2019-12-14 00:12 UTC2019-12N021524-002M-2212021-02-143f01610625f2…
2019-12-14 00:12 UTC2019-12N021524-003M-2212021-02-143f01610625f2…
2019-09-15 20:21 UTC2019-09N021524-001M-2212021-02-14b00525d2431f…
2019-09-15 20:21 UTC2019-09N021524-002M-2212021-02-14b00525d2431f…
2019-09-15 20:21 UTC2019-09N021524-003M-2212021-02-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N021524-001M-2212021-02-14ea99ee380514…
2019-07-19 19:46 UTC2019-07N021524-002M-2212021-02-14ea99ee380514…
2019-07-19 19:46 UTC2019-07N021524-003M-2212021-02-14ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Prevantics Swabstick
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE31.5 mg/mL
ISOPROPYL ALCOHOL.7 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MOR84MUD8EInternal UNII lookup
ND2M416302Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1191171Internal RxNorm lookup
1366736Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9841200b-d4c6-b40c-e053-2995a90a5596Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10819-4077-1Prevantics Swabstick1.6 mL in 1 POUCHSOLUTION1.63
10819-4077-2Prevantics Swabstick500 in 1 CASESOLUTION5003
10819-4077-2Prevantics Swabstick1.6 mL in 1 POUCHSOLUTION1.63
10819-4077-3Prevantics Swabstick500 in 1 CASESOLUTION5003
10819-4077-3Prevantics Swabstick1.6 mL in 1 POUCHSOLUTION1.63
10819-4077-4Prevantics Swabstick50 in 1 BOXSOLUTION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10819-4077PREVANTICS SWABSTICK (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.]3Current NDC, Legacy NDC, 6 package rows20250212_9841200b-d4c6-b40c-e053-2995a90a5596.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.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prevantics SwabstickCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLProfessional Disposables International, Inc.9841200b-d4c6-b40c-e053-2995a90a55962025-02-10WarningsExact identifier
application applno (NDA): 021524
application number: NDA021524
ndc (product): 10819-4077
Prevantics SwabCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLProfessional Disposables International, Inc.ff999b50-0b6b-404e-b4f1-c6694fe47a9b2023-10-13WarningsExact identifier
application applno (NDA): 021524
application number: NDA021524
Prevantics SwabCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLProfessional Disposables International, Inc.db61e7fd-c421-4e3c-bc88-0343230273de2023-10-13WarningsExact identifier
application applno (NDA): 021524
application number: NDA021524
Prevantics Maxi SwabstickCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLProfessional Disposables International, Inc.93ca3c07-40b4-3a91-e053-2995a90a0afd2023-06-30WarningsExact identifier
application applno (NDA): 021524
application number: NDA021524

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191171chlorhexidine gluconate 3.15 % / Isopropyl Alcohol 70 % Medicated PadPSN9841200b-d4c6-b40c-e053-2995a90a55963
1366736Prevantics 3.15 % / 70 % SwabstickPSN9841200b-d4c6-b40c-e053-2995a90a55963
1366736chlorhexidine gluconate 31.5 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated Pad [Prevantics]SBD9841200b-d4c6-b40c-e053-2995a90a55963
1191171chlorhexidine gluconate 31.5 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated PadSCD9841200b-d4c6-b40c-e053-2995a90a55963
1366736Prevantics (chlorhexidine gluconate 3.15 % / isopropyl alcohol 70 % ) SwabstickSY9841200b-d4c6-b40c-e053-2995a90a55963
1366736Prevantics (chlorhexidine gluconate 31.5 MG/ML / isopropyl alcohol 0.7 ML/ML) Medicated PadSY9841200b-d4c6-b40c-e053-2995a90a55963

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10819-4077-1108194077011.6 mL in 1 POUCH1.6 mlHistorical
10819-4077-210819407702500 POUCH in 1 CASE (10819-4077-2) / 1.6 mL in 1 POUCH500 pouch2020-06-010000-00-00NoNoCurrent
10819-4077-310819407703500 POUCH in 1 CASE (10819-4077-3) / 1.6 mL in 1 POUCH500 pouch2020-06-010000-00-00NoNoCurrent
10819-4077-41081940770450 POUCH in 1 BOX (10819-4077-4) / 1.6 mL in 1 POUCH (10819-4077-1) 50 pouch2020-06-010000-00-00NoNoCurrent