Halyard Chlorhexidine Gluconate

Product NDC
39892-0961
11-digit product format
398920961
Labeler code
39892
Product ID
39892-0961_262e2654-25de-cddb-e063-6394a90a8e58
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorhexidine Gluconate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Owens & Minor, Inc.
Application
NDA019258
Marketing category
NDA
Marketing start
2024-07-31
Substance
CHLORHEXIDINE GLUCONATE
Active strength
40 mg/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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019258-001CIDA-STATCHLORHEXIDINE GLUCONATE2%SOLUTION / TOPICAL1986-07-22
N019258-002CHG SCRUBCHLORHEXIDINE GLUCONATE4%SOLUTION / TOPICAL1986-07-22

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-22caaa826d4ba7…
2026-08-18 06:07:402026-07N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-22bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Halyard Chlorhexidine Gluconate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE40 mg/mL

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
211365Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
262e1975-bf99-cd3f-e063-6394a90a0a5bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39892-0961-1Halyard Chlorhexidine Gluconate118 mL in 1 BOTTLE, PLASTICSOLUTION1181
39892-0961-2Halyard Chlorhexidine Gluconate118 mL in 1 CASESOLUTION1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39892-0961HALYARD CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE GLUCONATE) SOLUTION [OWENS & MINOR, INC.]1Current NDC, 2 package rows20241106_262e1975-bf99-cd3f-e063-6394a90a0a5b.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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%CHLORHEXIDINE GLUCONATEHenry Schein, Inc.4b0b50ef-78e1-5595-e063-6294a90aa84d2026-02-17WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%CHLORHEXIDINE GLUCONATEHenry Schein, Inc.4b0c6bcd-2242-f734-e063-6294a90a8fbf2026-02-17WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%CHLORHEXIDINE GLUCONATEHenry Schein, Inc.4b0d7b42-5757-6248-e063-6394a90a94c52026-02-17WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATERising Pharma Holdings, Inc.d53a01eb-7213-4f19-b74f-acbf0fd544182026-02-10WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
Scrub-StatCHLORHEXIDINE GLUCONATEEcolab Inc.20e79dbb-8f33-469d-a7ca-29afde16a8ee2026-01-02WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
Scrub-StatCHLORHEXIDINE GLUCONATEEcolab Inc.4b4b02c7-b44a-483e-8e6b-79d9940374902025-12-31WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
Bactoshield CHGCHLORHEXIDINE GLUCONATESC Johnson Professional USA, Inc.5d49522f-63e5-4297-adf5-b5f3bd419d472025-07-09WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
Bactoshield CHGCHLORHEXIDINE GLUCONATESC Johnson Professional USA, Inc.da5d244d-e9c1-45a5-8f4e-ed1d3b9d02a92025-07-09WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
Scrub-StatCHLORHEXIDINE GLUCONATEEcolab Inc.b4444803-034c-4e22-9a21-9e07207df36e2024-10-03WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
Scrub-StatCHLORHEXIDINE GLUCONATEEcolab Inc.c126e473-e9ae-4749-a5e9-07191ec8c1fb2024-10-03WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
Halyard Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEOwens & Minor, Inc.240c5de0-dc33-1bb8-e063-6394a90ac7012024-09-04WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
Halyard Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEOwens & Minor, Inc.262e1975-bf99-cd3f-e063-6394a90a0a5b2024-09-04WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
ndc (product): 39892-0961
Scrub, Scrub-Stat, Foam Safe, Micro-GuardCHLORHEXIDINE GLUCONATEAVA, Inc.1f1eebef-9aac-b847-e063-6394a90a26cc2024-08-07WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
Scrub, Scrub-Stat, Foam Safe, Micro-GuardCHLORHEXIDINE GLUCONATEAVA, Inc.3e3c8e79-230e-4dd3-e054-00144ff88e882024-05-02WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
Scrub, Scrub-Stat, Foam Safe, Micro-GuardCHLORHEXIDINE GLUCONATEAVA, Inc.3e398787-7003-6502-e054-00144ff88e882023-11-03WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
Scrub, Scrub-Stat, Foam Safe, Micro-GuardCHLORHEXIDINE GLUCONATEAVA, Inc.3e3d67c6-180c-1d9c-e054-00144ff8d46c2023-11-03WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
Scrub, Scrub-Stat, Foam Safe, Micro-GuardCHLORHEXIDINE GLUCONATEAVA, Inc.42b0a0a9-6c5e-45c7-e054-00144ff88e882023-11-03WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
Scrub, Scrub-Stat, Foam Safe, Micro-GuardCHLORHEXIDINE GLUCONATEAVA, Inc.3e3bcbd1-de23-4d86-e054-00144ff8d46c2023-11-03WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
Scrub, Scrub-Stat, Foam Safe, Micro-GuardCHLORHEXIDINE GLUCONATEAVA, Inc.43401362-8e54-1f5d-e054-00144ff8d46c2023-11-03WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258
Scrub, Scrub-Stat, Foam Safe, Micro-GuardCHLORHEXIDINE GLUCONATEAVA, Inc.9dc6d487-b51b-985b-e053-2995a90a88232022-12-26WarningsExact identifier
application applno (NDA): 019258
application number: NDA019258

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN262e1975-bf99-cd3f-e063-6394a90a0a5b1
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD262e1975-bf99-cd3f-e063-6394a90a0a5b1
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY262e1975-bf99-cd3f-e063-6394a90a0a5b1
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY262e1975-bf99-cd3f-e063-6394a90a0a5b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
39892-0961-139892096101118 mL in 1 BOTTLE, PLASTIC (39892-0961-1) 118 ml2024-07-31NoNoCurrent
39892-0961-239892096102118 mL in 1 CASE (39892-0961-2) 118 ml2024-07-31NoNoCurrent