Dyna-Hex 2

Product NDC
0116-1022
11-digit product format
001161022
Labeler code
0116
Product ID
0116-1022_3400ba9f-d027-b3f7-e063-6394a90ac53a
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorhexidine Gluconate 2%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Xttrium Laboratories, Inc.
Application
NDA019422
Marketing category
NDA
Marketing start
2023-12-14
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

Additional Listing Data#

Finished product
Yes
Brand name base
Dyna-Hex 2
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMOR84MUD8E
Rxcui834160, 1245230

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
0116-1022-18Dyna-Hex 2535 mL in 1 BOTTLESOLUTION5353
0116-1022-32Dyna-Hex 2946 mL in 1 BOTTLESOLUTION9462

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-1022DYNA-HEX 2 (CHLORHEXIDINE GLUCONATE 2%) SOLUTION [XTTRIUM LABORATORIES, INC.]3Current NDC, Legacy NDC, 1 package rows20201014_36e6abcb-d792-3ef4-e054-00144ff8d46c.zip
0116-1022DYNA-HEX 2 (CHLORHEXIDINE GLUCONATE 2%) SOLUTION [XTTRIUM LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250503_0c808ebd-1bf7-175d-e063-6294a90ae7df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapPSN36e6abcb-d792-3ef4-e054-00144ff8d46c3
834160DYNA-HEX 2 2 % Medicated Liquid SoapPSN36e6abcb-d792-3ef4-e054-00144ff8d46c3
834160chlorhexidine gluconate 20 MG/ML Medicated Liquid Soap [Dyna-Hex]SBD36e6abcb-d792-3ef4-e054-00144ff8d46c3
1245230chlorhexidine gluconate 20 MG/ML Medicated Liquid SoapSCD36e6abcb-d792-3ef4-e054-00144ff8d46c3
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapSY36e6abcb-d792-3ef4-e054-00144ff8d46c3
834160Dyna-Hex 2 % Medicated Liquid SoapSY36e6abcb-d792-3ef4-e054-00144ff8d46c3
834160Dyna-Hex 20 MG/ML Medicated Liquid SoapSY36e6abcb-d792-3ef4-e054-00144ff8d46c3
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapPSN0c808ebd-1bf7-175d-e063-6294a90ae7df2
834160DYNA-HEX 2 2 % Medicated Liquid SoapPSN0c808ebd-1bf7-175d-e063-6294a90ae7df2
834160chlorhexidine gluconate 20 MG/ML Medicated Liquid Soap [Dyna-Hex]SBD0c808ebd-1bf7-175d-e063-6294a90ae7df2
1245230chlorhexidine gluconate 20 MG/ML Medicated Liquid SoapSCD0c808ebd-1bf7-175d-e063-6294a90ae7df2
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapSY0c808ebd-1bf7-175d-e063-6294a90ae7df2
834160Dyna-Hex 2 % Medicated Liquid SoapSY0c808ebd-1bf7-175d-e063-6294a90ae7df2
834160Dyna-Hex 20 MG/ML Medicated Liquid SoapSY0c808ebd-1bf7-175d-e063-6294a90ae7df2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0116-1022-1800116102218535 mL in 1 BOTTLE (0116-1022-18) 535 ml2016-01-290000-00-00NoNoCurrent
0116-1022-3200116102232946 mL in 1 BOTTLE (0116-1022-32) 946 ml2023-12-14NoNoHistorical