FDA.reportPublic FDA data

Application 017768

Type
NDA
Sponsor
MOLNLYCKE HLTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HIBICLENSCHLORHEXIDINE GLUCONATESOLUTION;TOPICAL4%YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N017768-001HIBICLENSCHLORHEXIDINE GLUCONATE4%SOLUTION / TOPICALRLD, RS, Approved before 1982

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017768-001HIBICLENS4%SOLUTION / TOPICALRLD, RS, Approved before 1982a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HibiclensCHLORHEXIDINE GLUCONATEMolnlycke Health Care29b547bf-c08e-14c2-e054-00144ff88e882024-12-23WarningsExact identifier
application applno (NDA): 017768
application number: NDA017768
ndc (product): 0234-0575
HibiclensCHLORHEXIDINE GLUCONATEMolnlycke Health Care4275eb53-1a7e-4a91-aac1-1085f40fac882024-12-23WarningsExact identifier
application applno (NDA): 017768
application number: NDA017768
ndc (product): 0234-0575
HibiclensCHLORHEXIDINE GLUCONATEMolnlycke Health Care8b37a721-79bb-4051-95a7-fcb4edebfcb72024-12-23WarningsExact identifier
application applno (NDA): 017768
application number: NDA017768
ndc (product): 0234-0575
HibiclensCHLORHEXIDINE GLUCONATEAsclemed USA, Inc.c7363108-0b4e-4d8a-9ec8-ea048604ecb22024-10-05WarningsExact identifier
application applno (NDA): 017768
application number: NDA017768

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0234-0575HibiclensChlorhexidine GluconateMolnlycke Health CareNDACurrent
0234-0575HibiclensChlorhexidine GluconateMolnlycke Health CareNDACurrent
0234-0575HibiclensChlorhexidine GluconateMolnlycke Health CareNDACurrent
0234-0575HibiclensChlorhexidine GluconateMolnlycke Health CareNDACurrent
0234-0575HibiclensChlorhexidine GluconateMolnlycke Health CareNDACurrent
0234-0575HibiclensChlorhexidine GluconateMolnlycke Health CareNDACurrent
0234-0575HibiclensChlorhexidine GluconateMolnlycke Health CareNDACurrent
0234-0575HibiclensChlorhexidine GluconateMolnlycke Health CareNDACurrent
0234-0575HibiclensChlorhexidine GluconateMolnlycke Health CareNDACurrent
0234-0575HibiclensChlorhexidine GluconateMolnlycke Health CareNDACurrent
0234-0575HibiclensChlorhexidine GluconateMolnlycke Health CareNDACurrent
0234-0575HibiclensChlorhexidine GluconateMolnlycke Health CareNDACurrent
50090-2354HibiclensChlorhexidine GluconateA-S Medication SolutionsNDACurrent
50090-2354HibiclensChlorhexidine GluconateA-S Medication SolutionsNDACurrent
54622-575Hibiclens for Georgia PacificChlorhexidine GluconateGeorgia-Pacific Consumer Products LPNDACurrent
54622-575Hibiclens for Georgia PacificChlorhexidine GluconateGeorgia-Pacific Consumer Products LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84033SUPPL 2025-11-03
84005SUPPL 2025-10-31
74933SUPPL 2023-07-31
74920SUPPL 2023-07-28
74618SUPPL 2023-06-23
74611SUPPL 2023-06-23
70170SUPPL2022-02-15
70162SUPPL2022-02-15
69954SUPPL2022-01-24
69952SUPPL2022-01-24
57052SUPPL2018-12-30
50144SUPPL2017-10-23
50115SUPPL2017-10-19
11060SUPPL2015-12-15
33342SUPPL2014-07-31
698SUPPL2014-07-01
13898SUPPL2012-05-29