FDA.reportPublic FDA data

Reckitt Benckiser LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25314493003979157Reckitt Benckiser LLC1Y2026-01-01360 Independence Avenue Harrisburg PA US 17102
30101643643008264702Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd.1N2026-01-0165 Moo 12 Lardkrabang-Bangplee Rd., Bangplee-Yai Bangplee Samut Prakan TH 10540
30110155683011015568Reckitt Benckiser LLC1Y2026-01-01100 Metro Blvd Nutley NJ US 07110
96106433002807985Reckitt Benckiser Healthcare (UK) Ltd.1N2020-04-25Dansom Lane Hull East Riding of Yorkshire United Kingdom GB HU8 7DS

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1318411684655058K980319DUREX ULTRA COMFORTHIS1998-05-20
1722551684655058K980319DUREX ULTRA COMFORTHIS1998-05-20
1318411423839077K955648K-Y PERSONAL LUBRICANTHIS1996-06-21
1722551423839077K955648K-Y PERSONAL LUBRICANTHIS1996-06-21
1764641469435027K810310K-Y LUBRICATING JELLYKMJ1981-04-21
1722551648042347K810310K-Y LUBRICATING JELLYKMJ1981-04-21
1318411648042347K810310K-Y LUBRICATING JELLYKMJ1981-04-21
1722551152949839K243967ONE Nitrile CondomMOL2025-04-08
1722551409296329K241617Durex Polyisoprene CondomMOL2025-02-28
1722551695442585K240896ONE Nitrile CondomMOL2024-08-23
1722551050288137K223519Carex Hybrid Personal LubricantNUC2023-08-11
1722551044898794K222068Durex Penck III RegularHIS2022-10-12
1722551655599837K220489Durex Patronus CloseFit, Durex Patronus RegularHIS2022-11-07
1318411655599837K220489Durex Patronus CloseFit, Durex Patronus RegularHIS2022-11-07
1537091147095377K213892Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & MineNUC2023-03-07
1722551324472877K213400Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play StrawberryNUC2022-03-01
1537091324472877K213400Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play StrawberryNUC2022-03-01
1318411324472877K213400Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play StrawberryNUC2022-03-01
1722551321749940K211152Durex Condom with BenzocaineHIS2022-05-11
1318411321749940K211152Durex Condom with BenzocaineHIS2022-05-11
1537091571342932K211088Grosz Play FeelNUC2021-07-09
1722551571342932K211088Grosz Play FeelNUC2021-07-09
1318411571342932K211088Grosz Play FeelNUC2021-07-09
1537091328866851K201186KY Grosz JellyNUC2020-07-30
1722551328866851K201186KY Grosz JellyNUC2020-07-30
1318411328866851K201186KY Grosz JellyNUC2020-07-30
1722552046519728K193032KY Grosz LiquidNUC2020-04-20
1537092046519728K193032KY Grosz LiquidNUC2020-04-20
1318412046519728K193032KY Grosz LiquidNUC2020-04-20
1318411424476198K192982KY Grosz UltraGelNUC2020-04-14
1722551424476198K192982KY Grosz UltraGelNUC2020-04-14
1537091424476198K192982KY Grosz UltraGelNUC2020-04-14
1722551782205952K183505KY Banksy MoistureNUC2019-05-17
1537091782205952K183505KY Banksy MoistureNUC2019-05-17
1318411782205952K183505KY Banksy MoistureNUC2019-05-17
1722551172665836K183302KY Banksy AloeNUC2019-04-16
1537091172665836K183302KY Banksy AloeNUC2019-04-16
1318411172665836K183302KY Banksy AloeNUC2019-04-16
1722551231570126K173504K-Y SiliconeNUC2018-01-12
1537091231570126K173504K-Y SiliconeNUC2018-01-12
1318411231570126K173504K-Y SiliconeNUC2018-01-12
1318411560815897K151884K-Y Marilyn Pleasure GelNUC2016-01-11
1722551560815897K151884K-Y Marilyn Pleasure GelNUC2016-01-11
1537091560815897K151884K-Y Marilyn Pleasure GelNUC2016-01-11
1318411126842210K122219THEYFIT MALE CONDOMHIS2013-09-27
1722551126842210K122219THEYFIT MALE CONDOMHIS2013-09-27
1722551302013390K122061K-Y BRAND LIQUIBEADSNUC2013-11-08
1318411247426188K113061LARGE/EXTRA LAGRE CONDOMHIS2011-12-07
1722551247426188K113061LARGE/EXTRA LAGRE CONDOMHIS2011-12-07
1318411917112621K081886KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATEDHIS2009-02-06
1722551917112621K081886KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATEDHIS2009-02-06
1722551990263819K072421K-Y BRAND YOURS+MINENUC2008-03-06
1318411990263819K072421K-Y BRAND YOURS+MINENUC2008-03-06
1537091990263819K072421K-Y BRAND YOURS+MINENUC2008-03-06
1537091744688383K072236DUREX PLAY TINGLING AQUEOUS BASED LUBRICANTNUC2008-05-07
1722551744688383K072236DUREX PLAY TINGLING AQUEOUS BASED LUBRICANTNUC2008-05-07
1318411744688383K072236DUREX PLAY TINGLING AQUEOUS BASED LUBRICANTNUC2008-05-07
1318411322394750K072169DUREX SYNTHETIC POLYISOPRENE MALE CONDOMMOL2008-06-19
1722551322394750K072169DUREX SYNTHETIC POLYISOPRENE MALE CONDOMMOL2008-06-19
1537091336587699K070545K-Y BRAND WARMING LIQUIDNUC2007-03-23
1318411336587699K070545K-Y BRAND WARMING LIQUIDNUC2007-03-23
1722551336587699K070545K-Y BRAND WARMING LIQUIDNUC2007-03-23
1318411047101597K063385DUREX PLAY MASSAGE GEL LUBRICANTNUC2008-03-10
1537091047101597K063385DUREX PLAY MASSAGE GEL LUBRICANTNUC2008-03-10
1722551047101597K063385DUREX PLAY MASSAGE GEL LUBRICANTNUC2008-03-10
1537091892996184K042563DUREX PLAY WARMER LUBRICANTKMJ2005-02-23
1318411892996184K042563DUREX PLAY WARMER LUBRICANTKMJ2005-02-23
1722551892996184K042563DUREX PLAY WARMER LUBRICANTKMJ2005-02-23
1318411760908422K040185DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOMHIS2004-04-27
1722551760908422K040185DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOMHIS2004-04-27
1764641503888717K040164K-Y BRAND WARMING JELLY PERSONAL LUBRICANTNUC2004-04-05
1318411620170518K040164K-Y BRAND WARMING JELLY PERSONAL LUBRICANTNUC2004-04-05
1537091620170518K040164K-Y BRAND WARMING JELLY PERSONAL LUBRICANTNUC2004-04-05
1722551620170518K040164K-Y BRAND WARMING JELLY PERSONAL LUBRICANTNUC2004-04-05
1537091873833223K020827K-Y BRAND ULTRA GEL PERSONAL LUBRICANTNUC2002-06-12
1318411873833223K020827K-Y BRAND ULTRA GEL PERSONAL LUBRICANTNUC2002-06-12
1722551873833223K020827K-Y BRAND ULTRA GEL PERSONAL LUBRICANTNUC2002-06-12
1318411151310876K020659DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANTHIS2002-03-29
1722551151310876K020659DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANTHIS2002-03-29
1722551036612983
1722551179189800
1722551370903030
1318411519701335
1722551519701335
1318411777267984
1722551777267984
1722551782518796
1722551887362792
1722551968470414

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NUC492023-08-11
HIS192022-11-07
KMJ62005-02-23
MOL52025-04-08

NDC#

Biofreeze

Reckitt Benckiser LLC

Camphor, Capsaicin, Menthol

Biofreeze

Reckitt Benckiser LLC

Camphor, Capsaicin, Menthol

Biofreeze

Reckitt Benckiser LLC

Menthol, Unspecified form

Mucinex Fast-Max

Reckitt Benckiser LLC

acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

Mucinex Fast-Max

Reckitt Benckiser LLC

dextromethorphan hydrobromide and guaifenesin

Delsym

Reckitt Benckiser LLC

Dextromethorphan

156 records. Showing 1-40. Next

PMN#

SPOROX

1997-10-29

RECKITT BENCKISER, INC.