FDA.reportPublic FDA data

Application 076434

Type
ANDA
Sponsor
SUNSTAR AMERICAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PAROEXCHLORHEXIDINE GLUCONATESOLUTION;DENTAL0.12%NoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076434-001PAROEXCHLORHEXIDINE GLUCONATE0.12%SOLUTION / DENTAL2005-11-29

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATESage Products LLCbdb6a012-37e5-4664-84a3-134bea2847442026-06-16WarningsName fallback
Sponge with 4% w/w chlorhexidine gluconate (CHG)CHLORHEXIDINE GLUCONATEXinxiang Xinda Technology Co.,Ltd53f4dd22-e4ab-5d8a-e063-6294a90a8c392026-06-11WarningsName fallback
Swab Applicator Brushes 4% w/w chlorhexidine gluconate (CHG)CHLORHEXIDINE GLUCONATEXINXIANG XINDA TECHNOLOGY CO.,LTD51c1a74f-c6a8-b831-e063-6294a90a6c712026-05-24WarningsName fallback
Swab Stick 2% w/w chlorhexidine gluconate (CHG)CHLORHEXIDINE GLUCONATEXINXIANG XINDA TECHNOLOGY CO.,LTD51c5a926-d137-9119-e063-6294a90a88452026-05-24WarningsName fallback
Dyna-Hex 4CHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.0a32c299-f7ca-d15c-e063-6294a90af2c12026-04-30WarningsName fallback
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEBenco Dental21b03b2a-44ee-41c0-e054-00144ff8d46c2026-04-29Warnings, Adverse reactionsName fallback
Bactoshield CHGCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a6403ad-fa5e-2b4a-e054-00144ff8d46c2026-04-28WarningsName fallback
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a3a4cfe-88e0-0a10-e054-00144ff88e882026-04-27Warnings, Adverse reactionsName fallback
ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a9eda34-d85c-4b66-e054-00144ff88e882026-04-27WarningsName fallback
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a3a684f-5f72-347a-e054-00144ff8d46c2026-04-27Warnings, Adverse reactionsName fallback
DYNA-HEX 2CHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.6cc89ac1-baef-40bb-85a3-d9ae9e3e7a632026-04-27WarningsName fallback
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEPreferred Pharmaceuticals, Inc.1c3401ef-6a7a-485e-ab7e-52420a36f4e22026-03-27Warnings, Adverse reactionsName fallback
CleanCare Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATESafco Dental Supply LLC0d950be9-9d25-202c-e063-6294a90ada7d2026-03-02Warnings, Adverse reactionsName fallback
CleanCare Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATESafco Dental Supply LLC0d9624f6-2a0b-c30f-e063-6294a90ae7172026-03-02Warnings, Adverse reactionsName fallback
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%CHLORHEXIDINE GLUCONATEHenry Schein, Inc.4b0b50ef-78e1-5595-e063-6294a90aa84d2026-02-17WarningsName fallback
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%CHLORHEXIDINE GLUCONATEHenry Schein, Inc.4b0c6bcd-2242-f734-e063-6294a90a8fbf2026-02-17WarningsName fallback
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%CHLORHEXIDINE GLUCONATEHenry Schein, Inc.4b0d7b42-5757-6248-e063-6394a90a94c52026-02-17WarningsName fallback
Periogard Alcohol FreeCHLORHEXIDINE GLUCONATEATLANTIC BIOLOGICALS CORP.f927717e-e743-43c4-a2b3-d5b83f2403b02026-02-13Warnings, Adverse reactionsName fallback
CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATERising Pharma Holdings, Inc.d53a01eb-7213-4f19-b74f-acbf0fd544182026-02-10WarningsName fallback
Surgical Scrub Brush/Sponge With Nail Cleaner 4% CHGCHLORHEXIDINE GLUCONATEXinxiang Xinda Technology Co.,Ltd125ac9df-03db-83e9-e063-6394a90afeab2026-01-08WarningsName fallback

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings 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 on patients allergic to chlorhexidine gluconate or any other ingredient in this product for lumbar punctures or in contact with the meninges on open skin wounds or as a general skin cleanser When using this product keep out of eyes, ears and mouth. May cause serious or permanent injury if chlorhexidine is permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor. Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0210PAROEXChlorhexidine GluconateATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0210PAROEXChlorhexidine GluconateATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0210PAROEXChlorhexidine GluconateATLANTIC BIOLOGICALS CORP.ANDACurrent
52376-021PAROEXchlorhexidine gluconateSunstar Americas, Inc.ANDACurrent
52376-021PAROEXchlorhexidine gluconateSunstar Americas, Inc.ANDACurrent
68094-028Paroex Chlorhexidine GluconateChlorhexidine GluconatePrecision Dose, Inc.ANDACurrent
68094-028Chlorhexidine GluconateChlorhexidine GluconatePrecision Dose, Inc.ANDACurrent
70166-027Chlorhexidine GluconateChlorhexidine GluconateLohxaANDACurrent
70166-027Chlorhexidine GluconateChlorhexidine GluconateLohxaANDACurrent