Ibuprofen / Pseudoephedrine Oral Tablet

Brand(s)
Advil Cold and Sinus, Wal-Profen Cold and Sinus
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Pfizer Consumer Healthcare (2012-02-27)
Oldest Current Product
1989-09-19
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\IBUPROFEN:PSEUDOEPHEDRINE
FDAOB
ORAL\TABLET\IBUPROFEN: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, COATED\IBUPROFEN: PSEUDOEPHEDRINE HYDROCHLORIDE
ORAL\TABLET, SUGAR COATED\IBUPROFEN: PSEUDOEPHEDRINE HYDROCHLORIDE
ORAL\TABLET\IBUPROFEN: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, COATED\IBUPROFEN: PSEUDOEPHEDRINE
ORAL\TABLET, SUGAR COATED\IBUPROFEN: PSEUDOEPHEDRINE
ORAL\TABLET\IBUPROFEN: PSEUDOEPHEDRINE

product(s) by strength(s)

ibuprofen 200 mg / pseudoephedrine hydrochloride 30 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005730180Advil Cold and SinusNDAPfizer Consumer Healthcare1989-09-19IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, COATEDNDA019771fac22a47-f0de-4505-fd8a-768430cda0c1

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001130083ANDAL. Perrigo Company2001-10-09IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567f273a521-1292-40b0-9d41-3522677705ca
2003630083Wal-Profen Cold and SinusANDAWalgreens2001-10-08IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567faa26964-a140-4d30-ab1e-19f49f9458ac
3003630423ANDAWalgreens2001-10-08IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, COATEDANDA074567c3b302c6-a2d2-491c-8f56-ecc25dd1f6c0
4116730083ANDATarget Corp2009-08-12IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA07456704816faa-ef2e-4f94-9e43-c31ee89a47b8
5116730423ANDATarget Corp2001-10-08IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, COATEDANDA074567d85b2343-cea2-4cd2-bf03-efa44f6d65fb
6118220083ANDARite Aid2001-10-08IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567fc5cb565-9c65-4a31-b24b-c30e1a60cc67
7211300083ANDABetter Living Brands Llc2001-10-30IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567bad190f1-22fe-4d2e-9a6f-7cb91ec2f2c6
8211300423ANDABetter Living Brands Llc2001-10-13IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567858972a4-db15-4822-9a5a-4d56813c0942
9243850465ANDAGood Neighbor Pharmacy2001-10-15IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLETANDA074567f93c8668-2b36-4ade-92a7-1c748f4fe67b
10301420083ANDAKroger2001-10-12IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567da96fcc0-e1e6-428e-bf07-be04711bb43c
11301420423ANDAKroger2001-10-13IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA0745672c15339d-a33b-4884-87d8-a3b50903a2c8
12368000083ANDATop Care (Topco Associates Llc)2001-10-09IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567ecfd7e18-9867-4b06-9ecb-4bf948036326
13368000423ANDATop Care (Topco Associates Llc)2001-10-08IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567d1d5a493-d792-47b1-818a-12c398cb8290
14372050199ANDACardinal Health2001-10-10IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567c546dd47-7704-45a0-8c4c-c6d18cca4e8a
15378080423ANDAH-E-B2001-10-13IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567421a0a2b-4238-4f1f-8824-6b3468f33470
16411630083ANDASupervalu, Inc2004-09-21IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567552080f7-3a34-4a45-80be-8477317b27a1
17412500083ANDAMeijer Distribution, Inc2001-10-08IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA07456746db2c02-1a06-4d40-81da-e8875b5f83ea
18412500423ANDAMeijer Distribution, Inc2001-10-13IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567cabd7e2b-c7ef-4557-a98d-f486abc82db3
19415200083ANDAFoodhold U.S.A., Llc2004-05-11IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567519784c5-f531-40d8-9936-5facc9660b2a
20425070083ANDAHy-Vee2001-10-15IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567b24bb894-e5ff-4433-a372-f1590401db93
21460840091ANDAA P J Laboratories Limited2013-06-01IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, COATEDANDA074567db492dad-ab1c-459d-842c-062e4b3f4c57
22490350083ANDAWalmart2001-11-07IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567342193c8-5346-4a8b-82cb-d9bd2e79a7c0
23493480097ANDASunmark2001-10-13IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567c55f2820-4d57-4492-9c80-2af9754ac563
24493480431ANDASunmark2003-08-28IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLETANDA0745677f044815-4519-46b5-a4c6-8efdd7c6d2da
25516600423ANDAOhm Laboratories Inc.2001-10-13IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA07456765ec0f85-7ca3-4adc-b152-a0ae2fd0692f
26516600490ANDAOhm Laboratories Inc.2001-10-13IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567c0692a21-358d-47b9-bbff-cc8f4f3bdb56
27516600493ANDAOhm Laboratories Inc.2001-10-13IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567cb7fb0d3-adf6-4c14-ac61-103dc869ebf2
28560620083ANDAPublix Super Markets, Inc2001-12-07IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA07456732757a3c-220b-43a1-b686-9ec04e01371c
29560620423ANDAPublix Super Markets, Inc2001-10-13IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA0745672b98a62b-bd92-4fb8-ad0f-521cb477b612
30597790430ANDACvs2001-10-11IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567627ea7db-47f1-40c2-b1ca-72dc66542e4a
31597790891ANDACvs2001-10-09IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA0745674af066f8-4f1d-4105-a782-b19653a3fbcc
32620110070ANDAMckesson (Health Mart)2001-10-13IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567d93ae778-e6e9-4d1d-8f46-c04d962a9393
33638680453ANDAQuality Choice (Chain Drug Marketing Association)2001-10-13IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567093e6388-54f2-4d04-ba55-8f7c9c182a0e
34680160423ANDAChain Drug Consortium, Llc2001-10-13IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATEDANDA074567f604ba33-dea5-44e1-a27c-a7e6766f0fa5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1636295284ANDABryant Ranch Prepack2001-10-13IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, SUGAR COATED516600423ANDA0745677249b0f9-b24c-4f7f-81f2-22473a4d5b0c
2682588902ANDADispensing Solutions, Inc.2001-10-15IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET243850465ANDA074567d60cc253-e77e-422a-aeb5-1565bf048d76

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA074567IBUPROHM COLD AND SINUSOHM LABORATORIES INC2001-04-17ANDA074567_001
2ANDA075588IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDECONTRACT PHARMACAL CORP2002-04-08ANDA075588_001
3ANDA077628IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEDR REDDYS LABORATORIES LTD2006-08-14ANDA077628_001
4NDA019771ADVIL COLD AND SINUSPFIZER INC1989-09-19NDA019771_001
5NDA019899SINE-AID IBJOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION1992-12-31NDA019899_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA074567_001OTCIBUPROFEN (200MG), PSEUDOEPHEDRINE HYDROCHLORIDE (30MG)ORALTABLETFalse2001-04-17IBUPROHM COLD AND SINUS
2ANDA075588_001OTCIBUPROFEN (200MG), PSEUDOEPHEDRINE HYDROCHLORIDE (30MG)ORALTABLETFalse2002-04-08IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
3ANDA077628_001OTCPSEUDOEPHEDRINE HYDROCHLORIDE (30MG), IBUPROFEN (200MG)ORALTABLETFalse2006-08-14IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
4NDA019771_001OTCPSEUDOEPHEDRINE HYDROCHLORIDE (30MG), IBUPROFEN (200MG)ORALTABLETTrue1989-09-19ADVIL COLD AND SINUS
5NDA019899_001OTCPSEUDOEPHEDRINE HYDROCHLORIDE (30MG), IBUPROFEN (200MG)ORALTABLETFalse1992-12-31SINE-AID IB

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
104816faa-ef2e-4f94-9e43-c31ee89a47b8 (view SPL)Target Corporation Cold and Sinus Drug FactsotcHuman OTCTarget Corp2010-05-171116730083
2093e6388-54f2-4d04-ba55-8f7c9c182a0e (view SPL)Drug FactsotcHuman OTCQuality Choice (Chain Drug Marketing Association)manufacture2012-09-122638680453
32b98a62b-bd92-4fb8-ad0f-521cb477b612 (view SPL)Drug FactsotcHuman OTCPublix Super Markets, Incmanufacture2013-01-041560620423
42c15339d-a33b-4884-87d8-a3b50903a2c8 (view SPL)Drug FactsotcHuman OTCKrogermanufacture2013-02-271301420423
532757a3c-220b-43a1-b686-9ec04e01371c (view SPL)Publix Super Markets, Inc. Ibuprofen Cold & Sinus Drug FactsotcHuman OTCPublix Super Markets, Inc2010-05-171560620083
6342193c8-5346-4a8b-82cb-d9bd2e79a7c0 (view SPL)Wal-Mart Ibuprofen Cold & Sinus Drug FactsotcHuman OTCWalmart2010-05-171490350083
7421a0a2b-4238-4f1f-8824-6b3468f33470 (view SPL)Drug FactsotcHuman OTCH-E-Bmanufacture2012-09-193378080423
846db2c02-1a06-4d40-81da-e8875b5f83ea (view SPL)Meijer Distribution, Inc. Ibuprofen Cold & Sinus Drug FactsotcHuman OTCMeijer Distribution, Inc2011-09-191412500083
94af066f8-4f1d-4105-a782-b19653a3fbcc (view SPL)CVS Pharmacy, Inc. Cold & Sinus Relief Drug FactsotcHuman OTCCvs2012-09-201597790891
10519784c5-f531-40d8-9936-5facc9660b2a (view SPL)American Sales Company Ibuprofen Cold & Sinus Drug FactsotcHuman OTCFoodhold U.S.A., Llc2011-09-191415200083
11552080f7-3a34-4a45-80be-8477317b27a1 (view SPL)SuperValu Inc. Ibuprofen Cold and & Sinus Drug FactsotcHuman OTCSupervalu, Inc2011-09-191411630083
12627ea7db-47f1-40c2-b1ca-72dc66542e4a (view SPL)Drug FactsotcHuman OTCCvsmanufacture2013-03-051597790430
1365ec0f85-7ca3-4adc-b152-a0ae2fd0692f (view SPL)DRUG FACTSotcHuman OTCOhm Laboratories Inc.manufacture2012-01-184516600423
147249b0f9-b24c-4f7f-81f2-22473a4d5b0c (view SPL)DRUG FACTSprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-101000636295284
157f044815-4519-46b5-a4c6-8efdd7c6d2da (view SPL)McKesson Ibuprofen Cold & Sinus Drug FactsotcHuman OTCSunmark2011-10-052493480431
16858972a4-db15-4822-9a5a-4d56813c0942 (view SPL)Drug FactsotcHuman OTCBetter Living Brands Llcmanufacture2012-09-262211300423
17b24bb894-e5ff-4433-a372-f1590401db93 (view SPL)Hy-Vee, Inc. Ibu-Profen Cold & Sinus Drug FactsotcHuman OTCHy-Vee2010-05-171425070083
18bad190f1-22fe-4d2e-9a6f-7cb91ec2f2c6 (view SPL)Safeway Inc. Cold & Sinus Pain Relief Drug FactsotcHuman OTCBetter Living Brands Llc2011-09-191211300083
19c0692a21-358d-47b9-bbff-cc8f4f3bdb56 (view SPL)Drug FactsotcHuman OTCOhm Laboratories Inc.manufacture2012-10-111516600490
20c3b302c6-a2d2-491c-8f56-ecc25dd1f6c0 (view SPL)Drug FactsotcHuman OTCWalgreensmanufacture2012-10-081003630423
21c546dd47-7704-45a0-8c4c-c6d18cca4e8a (view SPL)Cardinal Health Ibuprofen Cold & Sinus Drug FactsotcHuman OTCCardinal Health2010-05-171372050199
22c55f2820-4d57-4492-9c80-2af9754ac563 (view SPL)Drug FactsotcHuman OTCSunmarkmanufacture2012-08-152493480097
23cabd7e2b-c7ef-4557-a98d-f486abc82db3 (view SPL)Drug FactsotcHuman OTCMeijer Distribution, Incmanufacture2012-12-071412500423
24cb7fb0d3-adf6-4c14-ac61-103dc869ebf2 (view SPL)DRUG FACTSotcHuman OTCOhm Laboratories Inc.MANUFACTURE2014-09-121516600493
25d1d5a493-d792-47b1-818a-12c398cb8290 (view SPL)Drug FactsotcHuman OTCTop Care (Topco Associates Llc)manufacture2012-08-291368000423
26d60cc253-e77e-422a-aeb5-1565bf048d76 (view SPL)Amerisource Bergen Ibuprofen Cold and Sinus Drug FactsotcHuman OTCDispensing Solutions, Inc.relabel, repack2013-06-051682588902
27d85b2343-cea2-4cd2-bf03-efa44f6d65fb (view SPL)Drug FactsotcHuman OTCTarget Corpmanufacture2012-10-041116730423
28d93ae778-e6e9-4d1d-8f46-c04d962a9393 (view SPL)Drug FactsotcHuman OTCMckesson (Health Mart)manufacture2012-08-132620110070
29da96fcc0-e1e6-428e-bf07-be04711bb43c (view SPL)Kroger Co. Ibuprofen Cold & Sinus Drug FactsotcHuman OTCKroger2011-10-271301420083
30db492dad-ab1c-459d-842c-062e4b3f4c57 (view SPL)otcHuman OTCA P J Laboratories Limitedmanufacture2013-04-291460840091
31ecfd7e18-9867-4b06-9ecb-4bf948036326 (view SPL)Topco Associates LLC. Ibuprofen Cold & Sinus Drug FactsotcHuman OTCTop Care (Topco Associates Llc)2010-05-171368000083
32f273a521-1292-40b0-9d41-3522677705ca (view SPL)Perrigo Ibuprofen Cold & Sinus Drug FactsotcHuman OTCL. Perrigo Company2011-09-191001130083
33f604ba33-dea5-44e1-a27c-a7e6766f0fa5 (view SPL)Drug FactsotcHuman OTCChain Drug Consortium, LlcMANUFACTURE2015-10-063680160423
34f93c8668-2b36-4ade-92a7-1c748f4fe67b (view SPL)Amerisource Bergen Ibuprofen Cold and Sinus Drug FactsotcHuman OTCGood Neighbor Pharmacy2011-10-052243850465
35faa26964-a140-4d30-ab1e-19f49f9458ac (view SPL)Walgreen Co. Wal-Profen Cold & Sinus Drug FactsotcHuman OTCWalgreens2011-09-191003630083
36fac22a47-f0de-4505-fd8a-768430cda0c1 (view SPL)Advil Cold & Sinus Caplets(ibuprofen and pseudoephedrine HCl)otcHuman OTCPfizer Consumer HealthcareANALYSIS, LABEL, MANUFACTURE, PACK2012-02-277005730180
37fc5cb565-9c65-4a31-b24b-c30e1a60cc67 (view SPL)Rite Aid Corporation Ibu-Profen Cold & Sinus Drug FactsotcHuman OTCRite Aid2011-11-291118220083

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII