FDA.reportPublic FDA data

BETASEPT

Product NDC
67618-200
Requested package NDC
67618-200-01
11-digit product format
676180200
Labeler code
67618
Product ID
67618-200_872a571c-88d2-45f9-ae87-5b0b3c900939
Type
HUMAN OTC DRUG
Nonproprietary name
Antiseptic Surgical Scrub
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Atlantis Consumer Healthcare, Inc.
Application
NDA019125
Marketing category
NDA
Marketing start
1993-06-01
Substance
CHLORHEXIDINE GLUCONATE
Active strength
.04 mg/mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67618-20067618-200-01DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N019125-001DYNA-HEX 4CHLORHEXIDINE GLUCONATE4%SOLUTION / TOPICAL1984-12-24

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N019125-001DYNA-HEX 44%SOLUTION / TOPICAL1984-12-24a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Meijer Distribution, Inc.2821b691-0ece-0e35-e054-00144ff8d46c2026-04-29WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Bactoshield CHGCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a6403ad-fa5e-2b4a-e054-00144ff8d46c2026-04-28WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Bactoshield CHGCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.ee0317ff-0988-7621-e053-2a95a90a13fe2026-04-27WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Cardinal HealthCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.4a645652-ae2f-3811-e054-00144ff8d46c2026-04-27WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a9eda34-d85c-4b66-e054-00144ff88e882026-04-27WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
CliniCleanCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.f8352f15-b481-ee95-e053-6294a90ac5352026-04-27WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Antiseptic SolutionCHLORHEXIDINE GLUCONATE 4%Coloplast Corpc4e4068b-5e5e-a571-e053-2995a90a98a52026-03-27WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%CVS Pharmacy, Inc.46dc074c-af71-4805-e054-00144ff8d46c2026-03-03WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.48a814e7-bfe4-5437-e054-00144ff88e882026-03-03WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
BETASEPTANTISEPTIC SURGICAL SCRUBAtlantis Consumer Healthcare, Inc.7e64e7bf-e88f-4056-c9e1-b49a277daa6c2025-12-24WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
ndc (package): 67618-200-01
ndc (product): 67618-200
ndc11 (package): 67618020001
CliniCleanCHLORHEXIDINE GLUCONATE 4%HR Pharmaceuticals, Inc.f7959667-6275-802a-e053-6394a90aa7f12025-12-16WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Foster and ThriveCHLORHEXIDINE GLUCONATE 4%McKesson Corporation08b60f82-01db-3451-e063-6294a90a2bdc2025-12-16WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATECardinal Health7a7aeecf-ce26-5a66-e053-2991aa0ad4a22025-12-12WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%AmerisourceBergen Drug Corporation12ace9af-14ed-2dea-e054-00144ff8d46c2025-12-12WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Topco Associates LLCa0b7180a-0257-4a64-9d1a-6b6d824fac1c2025-12-12WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Chain Drug Marketing Association Inc.12234b17-fd07-6088-e054-00144ff88e882025-12-12WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.4aa41583-790c-2446-e054-00144ff8d46c2025-12-10WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.9f6342f7-faa3-4d23-a860-054d04cb8d422025-12-10WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.4a64f7c5-829c-6184-e054-00144ff88e882025-12-08WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125
Foster and ThriveCHLORHEXIDINE GLUCONATE 4%Xttrium Laboratories, Inc.0ce1b132-1f2d-d344-e063-6394a90a57d72025-12-08WarningsExact identifier
application applno (NDA): 019125
application number: NDA019125

Additional Listing Data#

Finished product
Yes
Brand name base
BETASEPT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE.04 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
834150Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7e64e7bf-e88f-4056-c9e1-b49a277daa6cAvailable 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
67618-200-01BETASEPT3785 mL in 1 BOTTLESOLUTION378513
67618-200-04BETASEPT118 mL in 1 BOTTLESOLUTION11813
67618-200-08BETASEPT237 mL in 1 BOTTLESOLUTION23713
67618-200-16BETASEPT473 mL in 1 BOTTLESOLUTION47313
67618-200-30BETASEPT946 mL in 1 BOTTLESOLUTION94613
67618-200-32BETASEPT946 mL in 1 BOTTLESOLUTION94613

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67618-200-01ML - Milliliter67618-2005702a901-38c3-493d-be08-8ece61e7853812013-02-13
67618-200-04ML - Milliliter67618-2003f81ce9c-97d1-4c53-9ea4-499277cccfae12013-02-13
67618-200-08ML - Milliliter67618-200bdfcd9fd-4e2d-41d3-be6f-eb8e864e6cba12013-02-13
67618-200-16ML - Milliliter67618-200c73e9a20-ed84-464c-b26e-a39732ec5c0a12013-02-13
67618-200-30ML - Milliliter67618-200239f33e8-6bf9-4785-a9bc-4a7dd58c43e612013-02-13
67618-200-32ML - Milliliter67618-20005c1a18c-da15-4ff3-8818-e2e12a463a8f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Chlorhexidine GluconateACTIVE INGREDIENTMOR84MUD8EBETASEPT (ANTISEPTIC SURGICAL SCRUB) SOLUTION [PURDUE PRODUCTS LP]2
ChlorhexidineACTIVE MOIETYR4KO0DY52LBETASEPT (ANTISEPTIC SURGICAL SCRUB) SOLUTION [PURDUE PRODUCTS LP]2
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DBETASEPT (ANTISEPTIC SURGICAL SCRUB) SOLUTION [PURDUE PRODUCTS LP]2
GLUCONOLACTONEINACTIVE INGREDIENTWQ29KQ9POTBETASEPT (ANTISEPTIC SURGICAL SCRUB) SOLUTION [PURDUE PRODUCTS LP]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BETASEPT (ANTISEPTIC SURGICAL SCRUB) SOLUTION [PURDUE PRODUCTS LP]2
LAURAMINE OXIDEINACTIVE INGREDIENT4F6FC4MI8WBETASEPT (ANTISEPTIC SURGICAL SCRUB) SOLUTION [PURDUE PRODUCTS LP]2
PEG-75 LANOLININACTIVE INGREDIENT09179OX7TBBETASEPT (ANTISEPTIC SURGICAL SCRUB) SOLUTION [PURDUE PRODUCTS LP]2
TRIDECYL ALCOHOLINACTIVE INGREDIENT8I9428H868BETASEPT (ANTISEPTIC SURGICAL SCRUB) SOLUTION [PURDUE PRODUCTS LP]2
WATERINACTIVE INGREDIENT059QF0KO0RBETASEPT (ANTISEPTIC SURGICAL SCRUB) SOLUTION [PURDUE PRODUCTS LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67618-200BETASEPT (ANTISEPTIC SURGICAL SCRUB) SOLUTION [ATLANTIS CONSUMER HEALTHCARE, INC.]11Current NDC, Legacy NDC, 6 package rows20250101_7e64e7bf-e88f-4056-c9e1-b49a277daa6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834150BETASEPT 4 % Medicated Liquid SoapPSN7e64e7bf-e88f-4056-c9e1-b49a277daa6c13
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN7e64e7bf-e88f-4056-c9e1-b49a277daa6c13
834150chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Betasept]SBD7e64e7bf-e88f-4056-c9e1-b49a277daa6c13
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD7e64e7bf-e88f-4056-c9e1-b49a277daa6c13
834150Betasept 4 % Medicated Liquid SoapSY7e64e7bf-e88f-4056-c9e1-b49a277daa6c13
834150Betasept 4 % Surgical ScrubSY7e64e7bf-e88f-4056-c9e1-b49a277daa6c13
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY7e64e7bf-e88f-4056-c9e1-b49a277daa6c13
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY7e64e7bf-e88f-4056-c9e1-b49a277daa6c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67618-200-01676180200013785 mL in 1 BOTTLE (67618-200-01) 3785 ml1993-06-010000-00-00NoNoCurrent