FDA.reportPublic FDA data

Foster and Thrive

Product NDC
0116-1221
11-digit product format
001161221
Labeler code
0116
Product ID
0116-1221_457511e0-22e0-e264-e063-6294a90ac8c5
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorhexidine Gluconate 4%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Xttrium Laboratories, Inc.
Application
NDA019125
Marketing category
NDA
Marketing start
2023-10-27
Marketing end
2027-01-31
Substance
CHLORHEXIDINE GLUCONATE
Active strength
4 g/100mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Current FDA listing
Yes

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
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
ndc (product): 0116-1221

Additional Listing Data#

Finished product
Yes
Brand name base
Foster and Thrive

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE4 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
211365Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ce1b132-1f2d-d344-e063-6394a90a57d7Available 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
0116-1221-01Foster and Thrive237 mL in 1 BOTTLESOLUTION2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-1221FOSTER AND THRIVE (CHLORHEXIDINE GLUCONATE 4%) SOLUTION [XTTRIUM LABORATORIES, INC.]2Current NDC, 1 package rows20250503_0ce1b132-1f2d-d344-e063-6394a90a57d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN0ce1b132-1f2d-d344-e063-6394a90a57d73
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD0ce1b132-1f2d-d344-e063-6394a90a57d73
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY0ce1b132-1f2d-d344-e063-6394a90a57d73
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY0ce1b132-1f2d-d344-e063-6394a90a57d73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0116-1221-0100116122101237 mL in 1 BOTTLE (0116-1221-01) 237 ml2023-10-272027-01-31NoNoHistorical