foaming hand wash

Product NDC
53329-994
11-digit product format
533290994
Labeler code
53329
Product ID
53329-994_3e4fe7f8-b082-5ac2-e063-6394a90afc08
Type
HUMAN OTC DRUG
Nonproprietary name
chlorhexidine gluconate
Dosage form
LIQUID
Route
TOPICAL
Labeler
Medline Industries, LP
Application
NDA019422
Marketing category
NDA
Marketing start
2020-01-01
Substance
CHLORHEXIDINE GLUCONATE
Active strength
20 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019422-001DYNA-HEX 2CHLORHEXIDINE GLUCONATE2%SOLUTION / TOPICALRLD, RS1985-12-17

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019422-001DYNA-HEX 22%SOLUTION / TOPICALRLD, RS1985-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-173f01610625f2…
2019-09-15 20:21 UTC2019-09N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17053a50430f4f…
2023-01-26 05:58 UTC2023-01N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019422-001EXIDINE2%SOLUTION / TOPICALRLD, RS1985-12-17e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
foaming hand wash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE20 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
1245230Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9b926809-65e9-4e5b-e053-2995a90add10Available 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
53329-994-84foaming hand wash1000 mL in 1 BOTTLELIQUID10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-994FOAMING HAND WASH (CHLORHEXIDINE GLUCONATE) LIQUID [MEDLINE INDUSTRIES, LP]4Current NDC, Legacy NDC, 1 package rows20220212_9b926809-65e9-4e5b-e053-2995a90add10.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DYNA-HEX 2CHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.6cc89ac1-baef-40bb-85a3-d9ae9e3e7a632026-04-27WarningsExact identifier
application applno (NDA): 019422
application number: NDA019422
Bactoshield CHGCHLORHEXIDINE GLUCONATE 2%Xttrium Laboratories, Inc.edfd2be7-b14b-7bd1-e053-2a95a90aa6682025-12-08WarningsExact identifier
application applno (NDA): 019422
application number: NDA019422
foaming hand washCHLORHEXIDINE GLUCONATEMedline Industries, LP9b926809-65e9-4e5b-e053-2995a90add102025-09-08WarningsExact identifier
application applno (NDA): 019422
application number: NDA019422
ndc (product): 53329-994
Provon Antimicrobial Foam HandwashCHLORHEXIDINE GLUCONATE 2%Xttrium Laboratories, Inc.46dd136c-d569-0450-e054-00144ff8d46c2025-04-30WarningsExact identifier
application applno (NDA): 019422
application number: NDA019422
DYNA-HEX 2CHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.6e5f9616-ddf5-19c4-e053-2991aa0a372a2025-04-30WarningsExact identifier
application applno (NDA): 019422
application number: NDA019422
Dyna-Hex 2CHLORHEXIDINE GLUCONATE 2%Xttrium Laboratories, Inc.0c808ebd-1bf7-175d-e063-6294a90ae7df2025-04-30WarningsExact identifier
application applno (NDA): 019422
application number: NDA019422
Purell Antimicrobial FoamCHLORHEXIDINE GLUCONATE 2% SOLUTIONGOJO Industries, Inc.6c7e63c2-428b-2be2-e053-2a91aa0a6af32024-12-21WarningsExact identifier
application applno (NDA): 019422
application number: NDA019422
Provon Antimicrobial Foam HandwashCHLORHEXIDINE GLUCONATE 2%Gojo Industries, Inc.365c3ac6-6c1f-594b-e054-00144ff88e882022-12-20WarningsExact identifier
application applno (NDA): 019422
application number: NDA019422
Bactoshield CHG Chlorhexidine GluconateCHLORHEXIDINE GLUCONATESC Johnson Professional USA, Inc.46084e90-6ffa-4e1a-a8ff-1c1b1484fe882022-11-28WarningsExact identifier
application applno (NDA): 019422
application number: NDA019422
Dyna-Hex 2CHLORHEXIDINE GLUCONATE 2%Xttrium Laboratories, Inc.36e6abcb-d792-3ef4-e054-00144ff8d46c2020-10-13WarningsExact identifier
application applno (NDA): 019422
application number: NDA019422
Provon Antimicrobial Foam HandwashCHLORHEXIDINE GLUCONATE 2%Gojo Industries, Inc.36803a5b-3075-5d5b-e054-00144ff8d46c2019-06-19WarningsExact identifier
application applno (NDA): 019422
application number: NDA019422
Antimicrobial Skin CleanserCHLORHEXIDINE GLUCONATE 2% SOLUTIONGojo Industries, Inc.759beac3-6fc8-40c6-e053-2a91aa0aab572019-06-18WarningsExact identifier
application applno (NDA): 019422
application number: NDA019422
Purell Antimicrobial FoamCHLORHEXIDINE GLUCONATE 2% SOLUTIONGOJO Industries, Inc.6e0f3d2f-7834-68a0-e053-2991aa0ab4532019-06-18WarningsExact identifier
application applno (NDA): 019422
application number: NDA019422
Antimicrobial Foam HandwashCHLORHEXIDINE GLUCONATE 2% SOLUTIONGOJO Industries, Inc.743021cd-38c3-3825-e053-2a91aa0aa7f22018-08-24WarningsExact identifier
application applno (NDA): 019422
application number: NDA019422
Antiseptic Foam HandwashCHLORHEXIDINE GLUCONATE 2% SOLUTIONGOJO Industries, Inc.74317b4d-3fbf-6fd5-e053-2a91aa0ab90f2018-08-24WarningsExact identifier
application applno (NDA): 019422
application number: NDA019422

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapPSN9b926809-65e9-4e5b-e053-2995a90add105
1245230chlorhexidine gluconate 20 MG/ML Medicated Liquid SoapSCD9b926809-65e9-4e5b-e053-2995a90add105
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapSY9b926809-65e9-4e5b-e053-2995a90add105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-994-84533290994841000 mL in 1 BOTTLE (53329-994-84) 1000 ml2020-01-010000-00-00NoNoCurrent