COMP Dyna-Hex 2: 8.5oz, 16oz, 8oz, 32oz, 1GL

Manufacturer
Xttrium Laboratories, Inc.
Effective date
2026-04-27
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:55:12

Label at a glance#

ProductDYNA-HEX 2
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure14 sections

Indications and uses

surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease skin wound and general skin cleansing

Dosage and administration

Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. Surgical hand scrub: wet hands and forearms under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner. scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers rins...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

chlorhexidine gluconate 2% solution

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • skin wound and general skin cleansing

Warnings

WARNINGS SECTION

For external use only

Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing
shock

facial swelling
hives
rash
If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with meninges
  • in the genital area

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes, ears and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums.
  • if solution should contact these areas, rinse out promptly and thoroughly with water
  • wounds that involve more than the superficial layers of the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done except when advised by a health care provider

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Surgical hand scrub:

wet hands and forearms under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner.

scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers

rinse thoroughly under running water for 30 seconds

wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds

dry thoroughly

Healthcare personnel handwash:
wet hands with water
dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 15 seconds

rinse and dry thoroughly

Skin wound and general skin cleaning:

thoroughly rinse the area to be cleaned with water

apply the minimum amount of product necessary to cover the skin or wound area and wash gently

rinse again thoroughly

Other information

SPL UNCLASSIFIED SECTION

  • store at 20-25° C (68-77° F)
  • avoid excessive heat above 40° C (104° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric add. cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-587-3721
Monday through Friday 8:00 AM to 4:30 PM CST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DYNA-HEX 2®

NDC 0116-1021-08

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

2BLDY08BTLLBLC

Net Wt 8 fl oz (237 mL)

Dyna-Hex 2 8oz single panelDyna-Hex 2 8oz single panel

NDC 0116-1021-85

DYNA-HEX 2®ANTIMICROBIAL HAND SOAP

Chlorhexidine Gluconate 2% Solution

Antiseptic

Contains: 2% Chlorhxidine Gluconate

FOR EXTERNAL USE ONLY

FDA approved formula

Helps Reduce Bacteria

Fragrance-Free

Used by Healthcare personnel in hospitals

Net Contents: 8.5 fl oz (251 mL)

2DYN85FLBL

2DYN85 Front2DYN85 Front

2DYN85 DF12DYN85 DF1

2DYN85 DF22DYN85 DF2

2DYN85 DF32DYN85 DF3

NDC 0116-1021-16

Dyna-Hex 2 ®

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

2DYN16BTLLBLD

Net Wt 16 fl oz (473 mL)

Dyna-Hex 2 16oz single panelDyna-Hex 2 16oz single panel

NDC 0116-1021-17

Dyna-Hex 2®

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

2BLDYNATLBLD

Net Wt 16 fl oz (473 mL)

Nat 1Nat 1

Nat 2Nat 2

nat 3nat 3

nat 4nat 4

NDC 0116-1021-32

Dyna-Hex 2®

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

2DYN32BTLLBLA

Net Wt 32 fl oz (946 mL)

PDP 32-oz Page 1PDP 32-oz Page 1

PDP 32-oz Page 2PDP 32-oz Page 2

PDP 32-oz Page 3PDP 32-oz Page 3

NDC 0116-1021-01

Dyna-Hex 2®

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

2DYN1GBTLLBLB

Net Wt 128 fl oz (1 gal)

Dyna-Hex 1 GallonDyna-Hex 1 Gallon

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapPSN11
834160DYNA-HEX 2 2 % Medicated Liquid SoapPSN11
834160chlorhexidine gluconate 20 MG/ML Medicated Liquid Soap [Dyna-Hex]SBD11
1245230chlorhexidine gluconate 20 MG/ML Medicated Liquid SoapSCD11
1245230chlorhexidine gluconate 2 % Medicated Liquid SoapSY11
834160Dyna-Hex 2 % Medicated Liquid SoapSY11
834160Dyna-Hex 20 MG/ML Medicated Liquid SoapSY11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130011610211601GTIN-13: 0011610211601
EAN-13: 0011610211601
GTIN-12: 011610211601
UPC-A: 011610211601
GTIN storage (14 digits): 00011610211601
Dyna-Hex 2 16oz - blank.jpg

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

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#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLORHEXIDINE GLUCONATEACTIVE INGREDIENTMOR84MUD8E3
CHLORHEXIDINEACTIVE MOIETYR4KO0DY52L3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP3
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972D3
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN163
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163023
LAURAMINE OXIDEINACTIVE INGREDIENT4F6FC4MI8W3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0116-10210116-1021-08, 0116-1021-16, 0116-1021-17, 0116-1021-32, 0116-1021-01, 0116-1021-85

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102025-12-10monthly-update2026-06-03 17:46:07

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 245 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route
119 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii+dosage form
119 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii+route
119 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii+route
119 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii+route
119 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
49 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
49 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii+route
119 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
49 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPEMULSION / TOPICAL0.11 %w/wExact identifier — unii+route
119 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16GEL / TOPICAL4 mgExact identifier — unii+route
28 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
49 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
49 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / TOPICALNAExact identifier — unii+route
119 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / TOPICALNAExact identifier — unii+route
119 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
49 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSUSPENSION / TOPICAL4 %w/wExact identifier — unii+route
35 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSOLUTION / TOPICAL2.5 %w/vExact identifier — unii+route
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+dosage form
119 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii+route
119 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLOTION / TOPICAL0.85 %w/wExact identifier — unii+route
119 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / RESPIRATORY (INHALATION)0.13 %w/wExact identifier — unii+dosage form
119 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
49 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+dosage form
119 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii+route
119 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii+route
119 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+dosage form
119 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
49 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / RESPIRATORY (INHALATION)0.13 %w/wExact identifier — unii+dosage form
119 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii+route
14 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii+route
119 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii+route
119 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii+route
14 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPEMULSION / TOPICAL0.11 %w/wExact identifier — unii+route
119 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / TOPICAL0.21 %w/vExact identifier — unii+route
28 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO, SUSPENSION / TOPICAL0.25 %w/vExact identifier — unii+route
119 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16GEL / TOPICAL4 mgExact identifier — unii+route
28 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / RESPIRATORY (INHALATION)0.13 %w/wExact identifier — unii+dosage form
119 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSOLUTION / TOPICAL2.5 %w/vExact identifier — unii+route
35 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
49 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii+route
119 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
49 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLOTION / TOPICAL0.85 %w/wExact identifier — unii+route
119 equally ranked IID candidates
LAURAMINE OXIDELAURAMINE OXIDE4F6FC4MI8WSOLUTION / TOPICAL3.5 %w/vExact identifier — unii+route
14 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / TOPICAL0.21 %w/vExact identifier — unii+route
28 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPOINTMENT / TOPICAL1 mgExact identifier — unii+route
119 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
49 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+dosage form
119 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
49 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSUSPENSION / TOPICAL4 %w/wExact identifier — unii+route
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii+route
119 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLOTION / TOPICAL0.85 %w/wExact identifier — unii+route
119 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
49 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
49 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSUSPENSION / TOPICAL4 %w/wExact identifier — unii+route
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSWAB / TOPICAL0.05 %w/wExact identifier — unii+route
119 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / RESPIRATORY (INHALATION)0.13 %w/wExact identifier — unii+dosage form
119 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / TOPICAL0.2 mgExact identifier — unii+route
119 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / TOPICAL0.69 %w/vExact identifier — unii+route
28 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSOLUTION / TOPICAL2.5 %w/vExact identifier — unii+route
35 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019422-001DYNA-HEX 22%SOLUTION / TOPICALRLD, RS1985-12-1784e616aacf4f…
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…

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 · 2 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
ndc (package): 0116-1021-08
ndc (package): 0116-1021-01
ndc (package): 0116-1021-16
ndc (package): 0116-1021-17
ndc (package): 0116-1021-85
ndc (package): 0116-1021-32
ndc (product): 0116-1021
ndc11 (package): 00116102132
ndc11 (package): 00116102108
ndc11 (package): 00116102101
ndc11 (package): 00116102117
ndc11 (package): 00116102185
ndc11 (package): 00116102116
spl id: 50770746-83a2-1eed-e063-6394a90a887e
spl set id: 6cc89ac1-baef-40bb-85a3-d9ae9e3e7a63
DYNA-HEX 2CHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.6e5f9616-ddf5-19c4-e053-2991aa0a372a2025-04-30WarningsExact identifier
ndc (product): 0116-1021

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.