Acetaminophen / Dextromethorphan / Doxylamine / Phenylephrine Oral Capsule

Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Bayer Healthcare Llc (2015-10-23)
Oldest Current Product
2012-05-30
License(s)
OTC MONOGRAPH FINAL
RxNORM
ORAL CAPSULE\ACETAMINOPHEN:DEXTROMETHORPHAN:DOXYLAMINE:PHENYLEPHRINE
SPL Active
ORAL\CAPSULE, LIQUID FILLED\ACETAMINOPHEN: DEXTROMETHORPHAN HYDROBROMIDE: DOXYLAMINE SUCCINATE: PHENYLEPHRINE HYDROCHLORIDE
ORAL\CAPSULE\ACETAMINOPHEN: DEXTROMETHORPHAN HYDROBROMIDE: DOXYLAMINE SUCCINATE: PHENYLEPHRINE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE, LIQUID FILLED\ACETAMINOPHEN: DEXTROMETHORPHAN: DOXYLAMINE: PHENYLEPHRINE
ORAL\CAPSULE\ACETAMINOPHEN: DEXTROMETHORPHAN: DOXYLAMINE: PHENYLEPHRINE

product(s) by strength(s)

acetaminophen 325 mg / dextromethorphan hydrobromide 10 mg / doxylamine succinate 6.25 mg / phenylephrine hydrochloride 5 mg oral capsule

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1001130345OTC MONOGRAPH FINALL. Perrigo Company2014-01-28ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLED0f251a73-ca3e-4390-b46f-57e7b483c701
2002801124OTC MONOGRAPH FINALBayer Healthcare Llc2013-07-08ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLED2fc59897-25a0-4516-a50b-64e4b2a9dd19
3002801125OTC MONOGRAPH FINALBayer Healthcare Llc2013-10-30ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLED42d75610-d62d-48d9-8364-7b1cf20d30d2
4002801435OTC MONOGRAPH FINALBayer Healthcare Llc2012-05-30ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLED642cdd2e-be58-4908-b412-3bdbea346f1c
5301420345OTC MONOGRAPH FINALKroger2014-05-14ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLED327b0e4c-d697-48b7-a708-0dcc318d8417
6368000345OTC MONOGRAPH FINALTop Care (Topco Associates Llc)2014-06-22ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLED2b384fbd-4a54-4c5f-9cc5-0e28b79658d0
7415200345OTC MONOGRAPH FINALFoodhold U.S.A., Llc2014-08-30ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLED58f559a8-ef00-4e1b-a0c9-84fc5b7d9ba9
8425070345OTC MONOGRAPH FINALHy-Vee2014-05-19ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLEDcb19f315-4a7f-45c0-85cf-6a1251a1fb37
9461220272OTC MONOGRAPH FINALAmerisource Bergen2014-12-21ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLED8b9211a6-5e8a-48e9-b3fb-ad69dbc758d6
10497810056OTC MONOGRAPH FINALCardinal Health, Inc.2013-11-21ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLED61a19c0f-ac4f-4424-a2af-f3a01972c48f
11533450020OTC MONOGRAPH FINALHumanwell Puracap Pharmaceutical (Wuhan), Ltd.2013-05-29ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLED590f4f0d-c8b0-412d-be1e-3eb2ccb29ac0
12553120345OTC MONOGRAPH FINALWestern Family2014-03-28ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLED2170e0d5-c69d-43db-8935-bf9a87eb199b
13617150141OTC MONOGRAPH FINALPreferred Plus (Kinray)2015-02-16ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLED890a2927-bd6b-49aa-9d87-5b68016a8a0a
14638240593OTC MONOGRAPH FINALReckitt Benckiser Llc2015-07-15ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLED8d64baa9-489a-48dc-8c03-6a66a52e44e0
15680160720OTC MONOGRAPH FINALChain Drug Consortium, Llc2015-09-23ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEORALCAPSULE3aee6110-944a-58f1-50a4-20ee52dca237

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10f251a73-ca3e-4390-b46f-57e7b483c701 (view SPL)Perrigo Severe Sinus Congestion Drug FactsotcHuman OTCL. Perrigo Company2015-04-142001130345
22170e0d5-c69d-43db-8935-bf9a87eb199b (view SPL)Western Family Allergy & Cough Drug FactsotcHuman OTCWestern Family2015-04-142553120345
32b384fbd-4a54-4c5f-9cc5-0e28b79658d0 (view SPL)Topco Associates LLC. Severe Sinus Congestion Drug FactsotcHuman OTCTop Care (Topco Associates Llc)2015-05-222368000345
42fc59897-25a0-4516-a50b-64e4b2a9dd19 (view SPL)Alka-Seltzer Plus Night Cold & Flu Formula Liquid GelsotcHuman OTCBayer Healthcare Llclabel, manufacture, pack2015-10-233002801124
5327b0e4c-d697-48b7-a708-0dcc318d8417 (view SPL)Kroger Co. Severe Sinus Congestion Drug FactsotcHuman OTCKroger2015-04-142301420345
63aee6110-944a-58f1-50a4-20ee52dca237 (view SPL)Multi-Symptom NIGHTTIME Cold and Flu Relief Plus Drug FactsotcHuman OTCChain Drug Consortium, Llcanalysis, manufacture, pack2015-10-131680160720
742d75610-d62d-48d9-8364-7b1cf20d30d2 (view SPL)Alka-Seltzer Plus Severe Sinus Congestion, Allergy & CoughotcHuman OTCBayer Healthcare Llc2013-07-082002801125
858f559a8-ef00-4e1b-a0c9-84fc5b7d9ba9 (view SPL)American Sales Company Severe Sinus Congestion Drug FactsotcHuman OTCFoodhold U.S.A., Llc2015-04-132415200345
9590f4f0d-c8b0-412d-be1e-3eb2ccb29ac0 (view SPL)Night Cold Flu Cough and Allergy capsule, liquid filledotcHuman OTCHumanwell Puracap Pharmaceutical (Wuhan), Ltd.ANALYSIS, MANUFACTURE2014-05-291533450020
1061a19c0f-ac4f-4424-a2af-f3a01972c48f (view SPL)Cardinal Health Severe Sinus Congestion Drug FactsotcHuman OTCCardinal Health, Inc.2015-04-142497810056
11642cdd2e-be58-4908-b412-3bdbea346f1c (view SPL)Alka-Seltzer Plus Night Cold & Flu FormulaotcHuman OTCBayer Healthcare Llc2012-04-301002801435
12890a2927-bd6b-49aa-9d87-5b68016a8a0a (view SPL)Kinray, LLC Severe Sinus Congestion Drug FactsotcHuman OTCPreferred Plus (Kinray)2015-05-142617150141
138b9211a6-5e8a-48e9-b3fb-ad69dbc758d6 (view SPL)Amerisource Bergen Severe Sinus Congestion Drug FactsotcHuman OTCAmerisource Bergen2015-04-142461220272
148d64baa9-489a-48dc-8c03-6a66a52e44e0 (view SPL)Mucinex Fast-Max Night Time Cold & FluotcHuman OTCReckitt Benckiser Llc2015-07-202638240593
15cb19f315-4a7f-45c0-85cf-6a1251a1fb37 (view SPL)Hy-Vee, Inc. Severe Sinus Congestion Drug FactsotcHuman OTCHy-Vee2015-04-142425070345

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