Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%

Product NDC
0404-0220
Requested package NDC
0404-0220-03
11-digit product format
004040220
Labeler code
0404
Product ID
0404-0220_4b0d7a8b-8db9-49d7-e063-6294a90a4fbd
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorhexidine Gluconate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Henry Schein, Inc.
Application
NDA019258
Marketing category
NDA
Marketing start
2021-11-17
Substance
CHLORHEXIDINE GLUCONATE
Active strength
40 mg/mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019258-001CIDA-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…
2021-12-28 21:50 UTC2021-12N019258-001CIDA-STAT2%SOLUTION / TOPICAL1986-07-22782e0a99824c…
2021-12-28 21:50 UTC2021-12N019258-002CHG SCRUB4%SOLUTION / TOPICAL1986-07-22782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%
Listing expiration
2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
211365Internal RxNorm lookup
2630838Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b0d7b42-5757-6248-e063-6394a90a94c5Available 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
0404-0220-03Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%236 mL in 1 BOTTLESOLUTION2361

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
ndc (package): 0404-0220-03
ndc (product): 0404-0220
ndc11 (package): 00404022003
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
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 SoapPSN4b0d7b42-5757-6248-e063-6394a90a94c51
2630838Maxiclens 4 % Medicated Liquid SoapPSN4b0d7b42-5757-6248-e063-6394a90a94c51
2630838chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Maxiclens]SBD4b0d7b42-5757-6248-e063-6394a90a94c51
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD4b0d7b42-5757-6248-e063-6394a90a94c51
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY4b0d7b42-5757-6248-e063-6394a90a94c51
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY4b0d7b42-5757-6248-e063-6394a90a94c51
2630838Maxiclens 4 % Medicated Surgical ScrubSY4b0d7b42-5757-6248-e063-6394a90a94c51
2630838Maxiclens 40 MG/ML Medicated Surgical ScrubSY4b0d7b42-5757-6248-e063-6394a90a94c51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0404-0220-0300404022003236 mL in 1 BOTTLE (0404-0220-03) 236 ml2021-11-17NoNoCurrent