FDA.reportPublic FDA data

Application 020774

Type
NDA
Sponsor
DEXCEL PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PERIOCHIPCHLORHEXIDINE GLUCONATETABLET;DENTAL2.5MGYesYes

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
N020774-001PERIOCHIPCHLORHEXIDINE GLUCONATE2.5MGTABLET / DENTALRLD1998-05-15

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 22:38:342026-08N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-1584e616aacf4f…
2026-08-18 06:07:402026-07N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD, RS1998-05-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD, RS1998-05-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD, RS1998-05-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD, RS1998-05-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD, RS1998-05-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD, RS1998-05-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD, RS1998-05-1587673890dc5c…
2021-03-12 10:30 UTC2021-03N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD, RS1998-05-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD, RS1998-05-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD, RS1998-05-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD, RS1998-05-153f01610625f2…
2019-09-15 20:21 UTC2019-09N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD, RS1998-05-15b00525d2431f…
2019-07-19 19:46 UTC2019-07N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD, RS1998-05-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-153f0d92c62455…
2023-05-13 08:27 UTC2023-05N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-15053a50430f4f…
2023-01-26 05:58 UTC2023-01N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-15f41ea6bd6efb…

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 2 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Periogard Alcohol FreeCHLORHEXIDINE GLUCONATEATLANTIC BIOLOGICALS CORP.f927717e-e743-43c4-a2b3-d5b83f2403b02026-02-13Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATERising Pharma Holdings, Inc.d53a01eb-7213-4f19-b74f-acbf0fd544182026-02-10WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Surgical Scrub Brush/Sponge With Nail Cleaner 4% CHGCHLORHEXIDINE GLUCONATEXinxiang Xinda Technology Co.,Ltd125ac9df-03db-83e9-e063-6394a90afeab2026-01-08WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Scrub-StatCHLORHEXIDINE GLUCONATEEcolab Inc.20e79dbb-8f33-469d-a7ca-29afde16a8ee2026-01-02WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Scrub-StatCHLORHEXIDINE GLUCONATEEcolab Inc.4b4b02c7-b44a-483e-8e6b-79d9940374902025-12-31WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATECardinal Health7a7aeecf-ce26-5a66-e053-2991aa0ad4a22025-12-12WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.9f6342f7-faa3-4d23-a860-054d04cb8d422025-12-10WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
BD E-Z Scrub 107CHLORHEXIDINE GLUCONATEBecton Dickinson and Company7c173111-11de-4585-af06-b329fe0290362025-12-08WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATESage Products LLC3c754532-d9a5-f876-00c4-05a4c9b21efa2025-10-21Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
foaming hand washCHLORHEXIDINE GLUCONATEMedline Industries, LP9b926809-65e9-4e5b-e053-2995a90add102025-09-08WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Bactoshield CHGCHLORHEXIDINE GLUCONATESC Johnson Professional USA, Inc.5d49522f-63e5-4297-adf5-b5f3bd419d472025-07-09WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Bactoshield CHGCHLORHEXIDINE GLUCONATESC Johnson Professional USA, Inc.da5d244d-e9c1-45a5-8f4e-ed1d3b9d02a92025-07-09WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a2c3c98-4e4e-1c9b-e054-00144ff88e882025-05-28Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEATLANTIC BIOLOGICALS CORP.ec1c2a9f-f0e3-c560-360a-2d2cbdd0cb7c2025-05-12Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEAtlantic Biologicals Corps.b445d769-a9e3-f72a-fbab-d485457996d02025-05-12Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
NUPRO Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a3b87bc-d913-6c88-e054-00144ff8d46c2025-04-30Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
DYNA-HEX 2CHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.6e5f9616-ddf5-19c4-e053-2991aa0a372a2025-04-30WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.6e5e678f-3832-d201-e053-2a91aa0a5ea82025-04-30WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATEMcKesson Medical-Surgical626d7aa9-b8da-4254-9c57-9007ed4290d42025-01-16WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATENuCare Pharmaceuticals,Inc.56e5e687-b1b5-6b43-e054-00144ff88e882024-12-31Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52096-001PerioChipChlorhexidine GluconateAdrian Pharmaceuticals, LLCNDACurrent
64239-101PerioChipChlorhexidine GluconateDexcel Pharma Technologies Ltd.NDACurrent
64239-101PerioChipChlorhexidine GluconateDexcel Pharma Technologies Ltd.NDACurrent
64239-101PerioChipChlorhexidine GluconateDexcel Pharma Technologies Ltd.NDACurrent
64239-101PerioChipChlorhexidine GluconateDexcel Pharma Technologies Ltd.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
3317SUPPL2012-11-09
13397SUPPL2012-11-08
35317SUPPL2012-01-23
25771SUPPL2012-01-17
13396SUPPL2011-07-07
3316SUPPL2011-06-14
35316SUPPL2004-04-05
25770SUPPL2004-03-03
35315SUPPL2002-12-15
25769SUPPL2002-12-15
20931ORIG1998-05-15
13395ORIG1998-05-15
3315ORIG1998-05-15