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 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
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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-09-29 23:25 UTC2022-09N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD1998-05-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020774-001PERIOCHIP2.5MGTABLET / DENTALRLD, RS1998-05-15cb3db0bc1861…

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 4 · 77 matching rows.

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

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