ReadyPrep CHG

Product NDC
53329-244
11-digit product format
533290244
Labeler code
53329
Product ID
53329-244_21b70574-3cd6-865f-e063-6394a90a54ba
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorhexidine gluconate 2%
Dosage form
CLOTH
Route
TOPICAL
Labeler
Medline Industries, LP
Application
NDA207964
Marketing category
NDA
Marketing start
2019-01-14
Substance
CHLORHEXIDINE GLUCONATE
Active strength
500 mg/1
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N207964-001READYPREP CHGCHLORHEXIDINE GLUCONATE2%CLOTH / TOPICALRLD, RS2018-11-20

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N207964-001READYPREP CHG2%CLOTH / TOPICALRLD, RS2018-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207964-001READYPREP CHG2%CLOTH / TOPICALRLD, RS2018-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-2087673890dc5c…
2021-03-12 10:30 UTC2021-03N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-203f01610625f2…
2019-09-15 20:21 UTC2019-09N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-20b00525d2431f…
2019-07-19 19:46 UTC2019-07N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-203f0d92c62455…
2023-05-13 08:27 UTC2023-05N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-20053a50430f4f…
2023-01-26 05:58 UTC2023-01N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N207964-001READYPREP CHG2%CLOTH / TOPICAL2018-11-20cb3db0bc1861…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N207964-001NP2021-11-2074a2ff9319b5…
2021-12-28 21:50 UTC2021-12N207964-001NP2021-11-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N207964-001NP2021-11-2087673890dc5c…
2021-03-12 10:30 UTC2021-03N207964-001NP2021-11-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N207964-001NP2021-11-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11N207964-001NP2021-11-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12N207964-001NP2021-11-203f01610625f2…
2019-09-15 20:21 UTC2019-09N207964-001NP2021-11-20b00525d2431f…
2019-07-19 19:46 UTC2019-07N207964-001NP2021-11-20ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
ReadyPrep CHG
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
846127Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
458cf999-5e3d-4d4d-82d5-02118c331893Available 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
53329-244-01ReadyPrep CHG2 in 1 POUCHCLOTH211
53329-244-03ReadyPrep CHG6 in 1 POUCHCLOTH611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-244-01EA - Each53329-2442919a665-504c-41ff-b172-d81aeab9612a12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-244READYPREP CHG (CHLORHEXIDINE GLUCONATE 2%) CLOTH [MEDLINE INDUSTRIES, LP]11Current NDC, Legacy NDC, 2 package rows20240910_458cf999-5e3d-4d4d-82d5-02118c331893.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ReadyPrep CHGCHLORHEXIDINE GLUCONATE 2%Medline Industries, LP458cf999-5e3d-4d4d-82d5-02118c3318932024-09-09WarningsExact identifier
application applno (NDA): 207964
application number: NDA207964
ndc (product): 53329-244

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
846127chlorhexidine gluconate 2 % Medicated PadPSN458cf999-5e3d-4d4d-82d5-02118c33189311
846127chlorhexidine gluconate 20 MG/ML Medicated PadSCD458cf999-5e3d-4d4d-82d5-02118c33189311
846127chlorhexidine gluconate 2 % Medicated PadSY458cf999-5e3d-4d4d-82d5-02118c33189311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-244-01533290244012 CLOTH in 1 POUCH (53329-244-01) 2 cloth2019-01-140000-00-00NoNoCurrent
53329-244-025332902440224 POUCH in 1 CARTON (53329-244-02) > 2 CLOTH in 1 POUCH (53329-244-01) 24 pouch2019-01-140000-00-00NoNoCurrent
53329-244-03533290244036 CLOTH in 1 POUCH (53329-244-03) 6 cloth2022-12-010000-00-00NoNoCurrent