DYNA-HEX

Product NDC
0116-1021
Requested package NDC
0116-1021-17
11-digit product format
001161021
Labeler code
0116
Product ID
0116-1021_3400b896-c408-acc1-e063-6294a90a9471
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorhexidine Gluconate
Dosage form
LIQUID
Route
TOPICAL
Labeler
Xttrium Laboratories, Inc.
Application
NDA019422
Marketing category
NDA
Marketing start
2014-01-01
Substance
CHLORHEXIDINE GLUCONATE
Active strength
2 g/100mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0116-10210116-1021-17DDiscontinued by firm2026-08-17

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
DYNA-HEX
Brand name suffix
2
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE2 g/100mL

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
834160Internal RxNorm lookup
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
6e5f9616-ddf5-19c4-e053-2991aa0a372aAvailable 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
0116-1021-01DYNA-HEX215142 mL in 1 JUGLIQUID1514211
0116-1021-08DYNA-HEX2237 mL in 1 BOTTLE, PLASTICLIQUID23711
0116-1021-16DYNA-HEX2473 mL in 1 BOTTLE, PLASTICLIQUID47311
0116-1021-17DYNA-HEX2473 mL in 1 BOTTLE, PLASTICLIQUID47311
0116-1021-32DYNA-HEX2946 mL in 1 BOTTLE, PLASTICLIQUID94611
0116-1021-85DYNA-HEX2250 mL in 1 BOTTLE, PUMPLIQUID25011
0116-1021-04DYNA-HEX2118 mL in 1 BOTTLE, PLASTICLIQUID1185

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0116-1021-04ML - Milliliter0116-1021620183db-4ad8-4631-aba0-2969edd1518d12024-08-12
0116-1021-16ML - Milliliter0116-102199dae371-2187-4f0b-85e8-52df57a4376a12024-04-05
0116-1021-17ML - Milliliter0116-1021e6e690bb-da83-437f-95dc-63d2c775094112024-04-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-1021DYNA-HEX 2 (CHLORHEXIDINE GLUCONATE) LIQUID [XTTRIUM LABORATORIES, INC.]9Current NDC, Legacy NDC, 6 package rows20250503_6cc89ac1-baef-40bb-85a3-d9ae9e3e7a63.zip
0116-1021DYNA-HEX 2 (CHLORHEXIDINE GLUCONATE) LIQUID [XTTRIUM LABORATORIES, INC.]5Current NDC, Legacy NDC, 1 package rows20250503_6e5f9616-ddf5-19c4-e053-2991aa0a372a.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
ndc (package): 0116-1021-17
ndc (product): 0116-1021
ndc11 (package): 00116102117
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
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
ndc (product): 0116-1021
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 SoapPSN6cc89ac1-baef-40bb-85a3-d9ae9e3e7a6311
834160DYNA-HEX 2 2 % Medicated Liquid SoapPSN6cc89ac1-baef-40bb-85a3-d9ae9e3e7a6311
834160chlorhexidine gluconate 20 MG/ML Medicated Liquid Soap [Dyna-Hex]SBD6cc89ac1-baef-40bb-85a3-d9ae9e3e7a6311
1245230chlorhexidine gluconate 20 MG/ML Medicated Liquid SoapSCD6cc89ac1-baef-40bb-85a3-d9ae9e3e7a6311
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapSY6cc89ac1-baef-40bb-85a3-d9ae9e3e7a6311
834160Dyna-Hex 2 % Medicated Liquid SoapSY6cc89ac1-baef-40bb-85a3-d9ae9e3e7a6311
834160Dyna-Hex 20 MG/ML Medicated Liquid SoapSY6cc89ac1-baef-40bb-85a3-d9ae9e3e7a6311
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapPSN6e5f9616-ddf5-19c4-e053-2991aa0a372a5
834160DYNA-HEX 2 2 % Medicated Liquid SoapPSN6e5f9616-ddf5-19c4-e053-2991aa0a372a5
834160chlorhexidine gluconate 20 MG/ML Medicated Liquid Soap [Dyna-Hex]SBD6e5f9616-ddf5-19c4-e053-2991aa0a372a5
1245230chlorhexidine gluconate 20 MG/ML Medicated Liquid SoapSCD6e5f9616-ddf5-19c4-e053-2991aa0a372a5
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapSY6e5f9616-ddf5-19c4-e053-2991aa0a372a5
834160Dyna-Hex 2 % Medicated Liquid SoapSY6e5f9616-ddf5-19c4-e053-2991aa0a372a5
834160Dyna-Hex 20 MG/ML Medicated Liquid SoapSY6e5f9616-ddf5-19c4-e053-2991aa0a372a5
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapPSN3ad6fa05-81e7-4055-e054-00144ff8d46c2
834160DYNA-HEX 2 2 % Medicated Liquid SoapPSN3ad6fa05-81e7-4055-e054-00144ff8d46c2
834160chlorhexidine gluconate 20 MG/ML Medicated Liquid Soap [Dyna-Hex]SBD3ad6fa05-81e7-4055-e054-00144ff8d46c2
1245230chlorhexidine gluconate 20 MG/ML Medicated Liquid SoapSCD3ad6fa05-81e7-4055-e054-00144ff8d46c2
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapSY3ad6fa05-81e7-4055-e054-00144ff8d46c2
834160Dyna-Hex 2 % Medicated Liquid SoapSY3ad6fa05-81e7-4055-e054-00144ff8d46c2
834160Dyna-Hex 20 MG/ML Medicated Liquid SoapSY3ad6fa05-81e7-4055-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0116-1021-1700116102117473 mL in 1 BOTTLE, PLASTIC (0116-1021-17) 473 ml2014-01-010000-00-00NoNoCurrent