Brompheniramine / Dextromethorphan / Pseudoephedrine Oral Solution

Brand(s)
Bromfed DM
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Paddock Laboratories, Llc (2015-02-10)
Oldest Current Product
2001-04-05
License(s)
ANDA, OTC MONOGRAPH FINAL
RxNORM
ORAL SOLUTION\BROMPHENIRAMINE:DEXTROMETHORPHAN:PSEUDOEPHEDRINE
FDAOB
ORAL\SYRUP\BROMPHENIRAMINE MALEATE: DEXTROMETHORPHAN HYDROBROMIDE: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Active
ORAL\ELIXIR\BROMPHENIRAMINE MALEATE: DEXTROMETHORPHAN HYDROBROMIDE: PSEUDOEPHEDRINE HYDROCHLORIDE
ORAL\LIQUID\BROMPHENIRAMINE MALEATE: DEXTROMETHORPHAN HYDROBROMIDE: PSEUDOEPHEDRINE HYDROCHLORIDE
ORAL\SYRUP\BROMPHENIRAMINE MALEATE: DEXTROMETHORPHAN HYDROBROMIDE: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Moiety
ORAL\ELIXIR\BROMPHENIRAMINE: DEXTROMETHORPHAN: PSEUDOEPHEDRINE
ORAL\LIQUID\BROMPHENIRAMINE: DEXTROMETHORPHAN: PSEUDOEPHEDRINE
ORAL\SYRUP\BROMPHENIRAMINE: DEXTROMETHORPHAN: PSEUDOEPHEDRINE

product(s) by strength(s)

brompheniramine 0.6 mg/ml / dextromethorphan 6 mg/ml / pseudoephedrine 10 mg/ml oral solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1164770562OTC MONOGRAPH FINALLaser Pharmaceuticals, Llc2008-01-02BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDEORALSYRUP54fa9022-7ae5-4a08-834e-482b725284d0

brompheniramine maleate 0.2 mg/ml / dextromethorphan hydrobromide 1 mg/ml / pseudoephedrine hydrochloride 3 mg/ml oral solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productspl
1006030852OTC MONOGRAPH FINALQualitest Pharmaceuticals2002-04-02BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDEORALLIQUIDf5dd4f8f-39f2-4ae8-a3fe-1fc03a12cc97
2006030864OTC MONOGRAPH FINALQualitest Pharmaceuticals2001-04-05BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDEORALELIXIRb3c8dbc9-c0b2-481f-822c-6f4c911a6f91
3548380136OTC MONOGRAPH FINALSilarx Pharmaceuticals, Inc2001-04-05BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDEORALLIQUIDbc89bbe9-3e31-4dca-a442-b60b696532b7
4687880852OTC MONOGRAPH FINALPreferred Pharmaceuticals, Inc.2001-04-05BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDEORALELIXIR0060308640654b093-2067-492f-a0bc-647dac430bde

brompheniramine maleate 0.2 mg/ml / dextromethorphan hydrobromide 4 mg/ml / pseudoephedrine hydrochloride 6 mg/ml oral solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1457370203OTC MONOGRAPH FINALAdvanced Generic Corporation2011-12-01BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDEORALLIQUID9eb28921-8917-4c82-9994-853e36c74431

brompheniramine maleate 0.4 mg/ml / dextromethorphan hydrobromide 2 mg/ml / pseudoephedrine hydrochloride 6 mg/ml oral solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1153100106OTC MONOGRAPH FINALCreekwood Pharmaceutical, Inc,2011-02-26BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDEORALSYRUP89beae5d-67ca-4da3-ae81-2cd59f27c618

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005741104ANDAPaddock Laboratories, Llc2015-02-06BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDEORALSYRUPANDA20529206db369d-09fe-4ca2-b98c-705356b7c403
2604320275ANDAMorton Grove Pharmaceuticals, Inc.2010-06-15BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDEORALSYRUPANDA088811655017cb-e6d4-4cef-869f-c25d6b246013
3604320837Bromfed DMANDAMorton Grove Pharmaceuticals, Inc.2010-06-15BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDEORALSYRUPANDA088811e241d83e-996c-494d-b3fe-97f1ef4809ed
4643760657ANDABoca Pharmacal, Llc2014-07-21BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDEORALSYRUPANDA2029405b64b800-5f5f-48d5-bb44-eb191b3aec67

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686377Bromfed DMANDAPhysicians Total Care, Inc.2012-10-26BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDEORALSYRUP604320837ANDA088811ccdf22f3-171f-4c19-8273-fefa140d1969
2581189978Bromfed DMANDAClinical Solutions Wholesale2009-08-21BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDEORALSYRUP604320837ANDA0888117e018414-ac11-4a0d-9e72-415715724822
3631870400ANDAProficient Rx Lp2010-06-15BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDEORALSYRUP604320275ANDA088811871632bb-0525-4e3b-a3ab-a50393bc9634

brompheniramine maleate 0.8 mg/ml / dextromethorphan hydrobromide 4 mg/ml / pseudoephedrine hydrochloride 4 mg/ml oral solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1586050151OTC MONOGRAPH FINALMcr American Pharmaceuticals, Inc.2007-11-30BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDEORALLIQUID5a6f21f8-651f-4559-98d8-bb2646a216ca

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA088722BROMANATE DMTrueALPHARMA US PHARMACEUTICALS DIVISION1985-03-07ANDA088722_001
2ANDA088811BROMFED-DMWOCKHARDT EU OPERATIONS (SWISS) AG1985-06-07ANDA088811_001
3ANDA089681BROMFED-DMTrueWOCKHARDT EU OPERATIONS (SWISS) AG1988-12-22ANDA089681_001
4ANDA202940BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEVINTAGE PHARMACEUTICALS2014-07-21ANDA202940_001
5ANDA205292BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEPADDOCK LABORATORIES LLC2014-07-15ANDA205292_001
6NDA019279DIMETANE-DXTrueAH ROBINS CO1984-08-24NDA019279_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA088722_001discontinuedBROMPHENIRAMINE MALEATE (2MG/5ML), DEXTROMETHORPHAN HYDROBROMIDE (10MG/5ML), PSEUDOEPHEDRINE HYDROCHLORIDE (30MG/5ML)ORALSYRUPFalse1985-03-07BROMANATE DM
2ANDA088811_001RXBROMPHENIRAMINE MALEATE (2MG/5ML), PSEUDOEPHEDRINE HYDROCHLORIDE (30MG/5ML), DEXTROMETHORPHAN HYDROBROMIDE (10MG/5ML)ORALSYRUPTrueAA1985-06-07BROMFED-DM
3ANDA089681_001discontinuedDEXTROMETHORPHAN HYDROBROMIDE (10MG/5ML), PSEUDOEPHEDRINE HYDROCHLORIDE (30MG/5ML), BROMPHENIRAMINE MALEATE (2MG/5ML)ORALSYRUPFalse1988-12-22BROMFED-DM
4ANDA202940_001RXPSEUDOEPHEDRINE HYDROCHLORIDE (30MG/5ML), DEXTROMETHORPHAN HYDROBROMIDE (10MG/5ML), BROMPHENIRAMINE MALEATE (2MG/5ML)ORALSYRUPFalseAA2014-07-21BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
5ANDA205292_001RXDEXTROMETHORPHAN HYDROBROMIDE (10MG/5ML), PSEUDOEPHEDRINE HYDROCHLORIDE (30MG/5ML), BROMPHENIRAMINE MALEATE (2MG/5ML)ORALSYRUPFalseAA2014-07-15BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
6NDA019279_001discontinuedPSEUDOEPHEDRINE HYDROCHLORIDE (30MG/5ML), DEXTROMETHORPHAN HYDROBROMIDE (10MG/5ML), BROMPHENIRAMINE MALEATE (2MG/5ML)ORALSYRUPFalse1984-08-24DIMETANE-DX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10654b093-2067-492f-a0bc-647dac430bde (view SPL)Q-Tapp DM ElixirotcHuman OTCPreferred Pharmaceuticals, Inc.repack2011-05-101687880852
206db369d-09fe-4ca2-b98c-705356b7c403 (view SPL)Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide SyrupprescriptionHuman PrescriptionPaddock Laboratories, Llc2015-02-102005741104
354fa9022-7ae5-4a08-834e-482b725284d0 (view SPL)NEO DM SYRUPotcHuman OTCLaser Pharmaceuticals, Llcmanufacture2011-10-192164770562
45a6f21f8-651f-4559-98d8-bb2646a216ca (view SPL)BrveXPSB DM LIQUIDotcHuman OTCMcr American Pharmaceuticals, Inc.MANUFACTURE2011-04-131586050151
55b64b800-5f5f-48d5-bb44-eb191b3aec67 (view SPL)BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUPprescriptionHuman PrescriptionBoca Pharmacal, LlcAPI MANUFACTURE, MANUFACTURE, PACK2014-08-082643760657
6655017cb-e6d4-4cef-869f-c25d6b246013 (view SPL)BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SYRUP 2 mg/30 mg/10 mg per 5 mLprescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.2014-08-201604320275
77e018414-ac11-4a0d-9e72-415715724822 (view SPL)BROMFED DM COUGH SYRUP (Brompheniramine Maleate 2 mg, Pseudoephedrine Hydrochloride 30 mg, and Dextromethorphan Hydrobromide 10 mg)prescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL2013-11-251581189978
8871632bb-0525-4e3b-a3ab-a50393bc9634 (view SPL)BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SYRUP 2 mg/30 mg/10 mg per 5 mLprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-03-271631870400
989beae5d-67ca-4da3-ae81-2cd59f27c618 (view SPL)Dimetane DX SyrupotcHuman OTCCreekwood Pharmaceutical, Inc,2011-03-041153100106
109eb28921-8917-4c82-9994-853e36c74431 (view SPL)DRUG FACTSotcHuman OTCAdvanced Generic Corporation2012-05-302457370203
11b3c8dbc9-c0b2-481f-822c-6f4c911a6f91 (view SPL)Q-Tapp DM ElixirotcHuman OTCQualitest Pharmaceuticals2010-12-023006030864
12bc89bbe9-3e31-4dca-a442-b60b696532b7 (view SPL)Brotapp DM Cold & Cough LiquidotcHuman OTCSilarx Pharmaceuticals, Inc2014-06-2713548380136
13ccdf22f3-171f-4c19-8273-fefa140d1969 (view SPL)BROMFED DM COUGH SYRUP (Brompheniramine Maleate 2 mg, Pseudoephedrine Hydrochloride 30 mg, and Dextromethorphan Hydrobromide 10 mg)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2013-02-051548686377
14e241d83e-996c-494d-b3fe-97f1ef4809ed (view SPL)BROMFED DM COUGH SYRUP (Brompheniramine Maleate 2 mg, Pseudoephedrine Hydrochloride 30 mg, and Dextromethorphan Hydrobromide 10 mg)prescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.2014-01-107604320837
15f5dd4f8f-39f2-4ae8-a3fe-1fc03a12cc97 (view SPL)Q-Tapp Cold and Cough Red Grape FlavorotcHuman OTCQualitest PharmaceuticalsMANUFACTURE2010-09-011006030852

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